CRM Product Performance Report 2013 - Boston …...CRM Quality Pledge I improve the quality of patient care and all things Boston Scienti˜c Transforming Lives through Innovative Medical

CRM Product Performance Report 2013Q1 Edition

CRM Quality Pledge

I improve

the quality

of patient care

and all things

Boston Scienti�c

Transforming Lives through Innovative Medical Solutions.

For a lm ost fo rty years , B oston S c ientific C R M has p rovided innova tive m ed ica l so lu tions that im prove the health o f pa tien ts a round the world . W e a re com m itted to p rovid ing perfo rm ance da ta wh ich a re accura te , transparen t and respons ive to top ics o f con tem porary c lin ica l in te res t. Th is Q 1 2013 report inc ludes da ta through January 16 , 2013 .

A ll data m eet o r exceed the AdvaM ed Industry G u idance fo r U n ifo rm R eporting o f C lin ica l P erfo rm ance , and address recom m endations from the H eart R hythm Soc ie ty Task Force on Lead Perfo rm ance . W ith increased in te res t in lead perfo rm ance , ou r Product Performance Report p rovides the m ost com prehensive p resenta tion o f lead perfo rm ance da ta availab le , inc lud ing:

• U .S . Lead surviva l probability • W orldw ide m alfunc tion counts and patterns • Longitud ina l S urve illance R eg is try lead surviva l probability • A cute (firs t m onth) lead observa tions • C hron ic (a fter firs t m onth) lead com plications • M alfunc tions reported before and during an im plant procedure

Your feedback is a lways we lcom e, and p lays a v ita l ro le in our e ffo rt to con tinuously im prove our products and se rvices , advancing science to transfo rm the lives o f ou r patien ts .

S incere ly,

R eno ld J . R ussie V ice P res iden t, Q ua lity A ssurance

STATISTICAL METHODOLOGY ........................................................ 2SUPPORTING GREATER RETURN OF EXPLANTED DEVICES ............... 7U.S. SURVIVAL PROBABILITYCARDIAC RESYNCHRONIZATIONTHERAPY DEFIBRILLATORS – CRT–D................................................ 9U.S. SURVIVAL PROBABILITYCARDIAC RESYNCHRONIZATIONTHERAPY DEFIBRILLATORS – CRT–P ...............................................17U.S. SURVIVAL PROBABILITYCARDIAC RESYNCHRONIZATIONTHERAPY – CRT LEAD ...................................................................18U.S. SURVIVAL PROBABILITYTACHYCARDIA THERAPY – ICD.............20U.S. SURVIVAL PROBABILITY– DEFIBRILLATION LEAD......................35U.S. SURVIVAL PROBABILITYBRADYCARDIA THERAPY –PACEMAKER ................................................................................41U.S. SURVIVAL PROBABILITYBRADYCARDIA THERAPY – PACINGLEAD...........................................................................................63MALFUNCTION DETAILS: OVERVIEW..............................................66MALFUNCTION DETAILS: PULSE GENERATORS – CRT–D ..................68MALFUNCTION DETAILS: PULSE GENERATORS – CRT–P ..................77MALFUNCTION DETAILS: PULSE GENERATORS – ICD ......................78MALFUNCTION DETAILS: PULSE GENERATORS –PACEMAKER ................................................................................90PATTERN DESCRIPTIONS - PULSE GENERATORS........................... 106MALFUNCTION DETAILS: LEAD – CRT............................................111MALFUNCTION DETAILS: LEAD – DEFIBRILLATION ........................ 113MALFUNCTION DETAILS: LEAD – PACING ..................................... 120PATTERN DESCRIPTIONS - LEADS................................................ 123U.S. CHRONIC LEAD COMPLICATIONS.......................................... 125U.S. ACUTE LEAD OBSERVATIONS ............................................... 128BEFORE/DURING IMPLANT PROCEDURE –WORLDWIDE MALFUNCTIONS: PULSE GENERATORS .................... 131BEFORE/DURING IMPLANT PROCEDURE –WORLDWIDE MALFUNCTIONS: LEADS ......................................... 137U.S. REASON FOR OUT OF SERVICE............................................. 140PRODUCT ADVISORIES ............................................................... 146INDEX ....................................................................................... 167

CONTACT INFORMATION ........................................................................ 169

MEDICAL REVIEW BOARD

RONALD D. BERGER, M.D. PHD, PROFESSOR OF MEDICINE, JOHNS HOPKINS UNIVERSITY

LEONARD GANZ, M.D., ASSOCIATE PROFESSOR OF MEDICINE, UNIVERSITY OF PITTSBURGH

MEDICAL CENTER

STEPHEN R. SHOROFSKY M.D., PH.D., PROFESSOR OF MEDICINE, UNIVERSITY OF

MARYLAND, SCHOOL OF MEDICINE

BOSTON SCIENTIFIC REVIEWERS

RENOLD J. RUSSIE, VICE PRESIDENT, QUALITY ASSURANCE

ARJUN SHARMA, M.D., VP OF MEDICAL SAFETY

ALEXANDRA NAUGHTON, DIRECTOR, QUALITY ASSURANCE

JACK LITZAU, M.S., PRINCIPAL STATISTICIAN

FOR A LIST OF TRADEMARKS, PLEASE SEE PAGE 6. REFER TO PRODUCT LABELING FOR SPECIFICINDICATIONS, CONTRAINDICATIONS, WARNINGS/PRECAUTIONS, AND ADVERSE EVENTS.

1 Boston Scientific CRM Product Performance Report published March 20, 2013


Statistical MethodologyWhat Is Device Survival Probability?Medical journals have traditionally used patient survival probability to displayinformation on treatment option effectiveness. In the report, pulse generator andlead survival probabilities convey information about long-term performance ofimplantable cardiac rhythm management products.

Survival probability shows the percentage of implanted devices that remainimplanted and in service at various points in a product’s service life, in the absenceof competing risks, such as natural mortality or voluntary explants. Conceptually,a pulse generator of high reliability and large battery capacity or low current drainremains near 100% survival until eventually, normal battery depletion begins to causesignificant numbers of devices to be removed, and the device survival probabilitydrops rapidly. For example, a device survival probability of 99% indicates thatwithin the stated implant duration, the pulse generator had a 1% risk of removal forbattery depletion or for incurring a malfunction that required replacement. Survivalprobabilities are provided with and without normal battery depletions (depicted as“Battery Depletions and Malfunctions” and “Malfunctions Only,“ respectively).

Boston Scientific estimates survival probability in compliance with internationalstandard ISO 5841-2: 2000 (E). Survival probability is calculated at a given timeby separately estimating the probability of surviving each interval and multiplyingthe survival probabilities of all intervals through which a device has passed.To estimate the probability of surviving any interval, the number of units thatsuccessfully functioned during the interval is divided by the number of unitsexposed to malfunction/depletion during the interval. The number of units exposedis calculated using the actuarial method, where device suspensions in an intervalare distributed uniformly across the interval. Reasons for device suspension fromsurvival probability statistics are detailed in the report section entitled U.S. Reasonfor Out of Service.

Survival probabilities are statistical estimates subject to uncertainty. To quantifythis uncertainty, 95% confidence intervals of survival probabilities are computed.Greenwood’s formula is used to estimate the standard error of the calculatedsurvival probabilities, and confidence intervals are constructed using a logittransformation, assuming the transformed values are normally distributed. For

example, 99.36% (-0.3/+0.2) represents an interval of 99.06% to 99.56%, andthese intervals are constructed such that 95% of the time they will contain thetrue survival probability. These confidence intervals are not symmetric due to thetransformation method described previously.

Inclusion Criteria for Pulse Generator and Lead Survival Probability DatasetsPulse generator survival probability is reported for U.S. implanted devices in productfamilies which meet inclusion criteria described below. Lead survival probability isreported for both the U.S. Registered Implant population and for leads enrolledin the Longitude Surveillance Registry, for product families which meet inclusioncriteria described below.

To be included in survival probability statistics, a device must first be successfullyimplanted (defined in this report as occurring upon pocket closure). Prophylacticdevice removals are tracked as part of the active population up until the time thedevice is removed from service; devices removed prophylactically which are notidentified as malfunctions at the time of explant do not contribute to a reductionin survival probability. Reasons for device explant or out of service, if known, areprovided in this report for each pulse generator product/product grouping.

Survival probabilities are based on devices registered as implanted in the UnitedStates. Privacy laws in many other geographies preclude manufacturers fromobtaining specific patient implant and explant information, thus device survivalprobabilities cannot be constructed from these data. Boston Scientific believes,however, that U.S. experience is generally representative of worldwide performance.The Malfunction Details for leads and pulse generators reflect worldwidemalfunctions, inclusive of U.S. data.

Criteria for inclusion of product families in this report are in compliance with theAdvaMed Industry Guidance for Uniform Reporting of Clinical Performance of PulseGenerators and Leads. Survival estimates are provided for product families oncethey have at least 10,000 cumulative U.S. implant months. The minimum intervalsample size is 200 U.S. implanted units. Pulse generator product families withless than 200 total remaining estimated active U.S. devices are not included in thisreport. Lead product families that received original U.S. market release approval

twenty or more years ago are not included in this report. Survival estimates for leadsenrolled in the Longitude Surveillance Registry are provided for product familiesonce they have at least 200 enrolled leads. The minimum interval sample size is 50leads which have been followed for at least 6 months.

Estimated Longevity information is provided for pulse generator products in the U.S.Survival Probability - Battery Depletions and Malfunctions graphs, depicted as a bluebar on the x axis for Years Implanted. The estimated longevity values from theInstructions for Use for each product family are used to construct the blue longevitybars on their U.S. Survival Probability graph. They represent the range of estimatedlongevity based on a variety of programmed settings and therapy usage.

Survival probability data are presented in tabular format in print, and in tabular andgraphical formats online at www.bostonscientific.com/ppr. Performance datafor Intermedics products may also be found on www.bostonscientific.com/ppr.Specific inclusion criteria for pulse generator and lead survival probability datasetsare described here. Not all products may be approved for use in all geographies, asproduct approval is geography specific.

Worldwide distribution and U.S. registered implant numbers have been roundedto provide population size context. A U.S. malfunction count and percentage aredisplayed for each product family within theU.S. Summary table. The malfunctionpercentage shown consists of total U.S. malfunctions divided by total registeredU.S. implants and is not intended to facilitate comparison of Boston Scientificdevice performance to that of competitive devices, nor is it intended to facilitategeneration-to-generation reliability comparisons. The information shown is intendedto put the malfunctions in context, relative to overall product distribution. Cumulativesurvival probability is a more accurate representation of overall product performance.

To convey implant experience for a product family, average device age and U.S.approval date are provided. The U.S. approval date listed is the earliest dateBoston Scientific received approval for one or more of the models in the family.For Longitude Surveillance Registry data, the number of enrolled leads and theircumulative followup months are also provided for context.

Survival Probability – Battery Depletions and Malfunctions (Pulse Generators)Reduction in survival probability for pulse generators is due to:

• Devices removed for normal battery depletion

• Device malfunctions occurring while implanted, as confirmed by returnedproduct analysis

• Devices removed from service and reported to have exhibited prematurebattery depletion, but not confirmed by laboratory analysis, whether returnedor not—also known as “unconfirmed reports of premature battery depletions”

Survival Probability – Malfunctions Only (Pulse Generators)Reduction in survival probability for pulse generators is due only to:

• Device malfunctions occurring while implanted, as confirmed by returnedproduct analysis; premature battery depletions are considered devicemalfunctions

In this case, normal battery depletions do not contribute to the reduction in survivalprobability; rather, reduction in survival probability is due only to confirmed pulsegenerator malfunctions. Futhermore, unconfirmed reports of premature batterydepletions do not reduce “Malfunctions Only” survival probability. Put anotherway, this information depicts the percentage of confirmed malfunction-free devicesremaining in service at various intervals in the product’s service life, based onreturned product analysis.

Survival Probability — Complications and Malfunctions (Leads)The AdvaMed Industry Guidance for Uniform Reporting of Clinical Performance ofCardiac Rhythm Management Pulse Generators and Leads, published in May 2009,outlines a methodology for lead survival probability inclusion. Boston Scientific hasapplied this methodology to all lead families currently being implanted as of May2009, and will apply it to all future lead families as they are included in the ProductPerformance Report. Lead families no longer being implanted as of May 2009 willcontinue to use previous reporting methodology.

Reduction in survival probability for current leads using AdvaMed Guidancemethodology is due to:

• Leads and lead segments returned for analysis and determined to benon-compliant in form, fit, or function at any time while implanted



• Leads and lead segments returned for analysis with reported observations30 days or more post-implant, but for which analysis was inconclusive or areported complication was unconfirmed

• Leads removed from service but not returned for laboratory analysis, withreported complications 30 days or more post-implant

Reduction in survival probability for older leads using previous methodology isdue to:

• Leads and lead segments returned for analysis and determined to benon-compliant in form, fit, or function at any time while implanted

• Leads not returned for laboratory analysis but reported to have discrepancywith mechanical integrity and/or impedance measurement 30 days or morepost-implant

Further Adjustments for Device and Lead SurvivalBecause underreporting of patient deaths unrelated to device function would resultin overestimation of pulse generator or lead survival by overstating the numberof devices in service, Boston Scientific addresses this underreporting in twoways. First, regular updates are obtained from the Social Security Administrationabout deceased persons and compared to Boston Scientific patient data to learnabout patients who have died but whose deaths had not been reported to BostonScientific. Second, Boston Scientific uses 10% annual patient mortality as a baselineand adjusts reported patient deaths in any interval for which reports are lessthan the baseline rate. No adjustment is applied to account for underreporting ofmalfunctions, as the rate of underreporting is unknown.

Boston Scientific does not make statistical adjustments to account forunderreporting of battery depletion. However, as mentioned earlier, BostonScientific includes non-returned devices removed from service for battery depletionwith no associated complaint as normal battery depletions.

Categorization of Malfunctions for Survival Probability ReportingMalfunctions represent pulse generators and leads removed from service andconfirmed through laboratory analysis to have operated outside the specifiedperformance limits established by Boston Scientific while implanted and in service.In addition, current leads utilizing AdvaMed methodology include Extrinsic Factormalfunctions occurring 30 days or more post-implant, where laboratory analysis is

inconclusive or unconfirmed. Device damage occurring during or after explant, orcaused by external factors including those warned against in product labeling (suchas ionizing therapeutic radiation), are not reported as device malfunctions in survivaldata. Damage to a pulse generator caused by a lead malfunction is reported as alead malfunction. Malfunctions are further classified according to their impact ontherapy, as follows:

Malfunction With Compromised Therapy —The condition when a device is confirmed through laboratory analysis to havemalfunctioned in a manner that compromised pacing or defibrillation therapy(including complete loss or partial degradation) while implanted and in service.

Examples include (but are not limited to): sudden loss of battery voltage; acceleratedcurrent drain such that low battery was not detected before loss of therapy; suddenmalfunction during defibrillation therapy resulting in aborted therapy delivery;intermittent malfunction in which therapy is compromised while in the malfunctionstate.

Malfunction Without Compromised Therapy —The condition when a device is confirmed through laboratory analysis to havemalfunctioned in a manner that did not compromise pacing or defibrillation therapywhile implanted and in service. Malfunctions in which critical patient-protectivepacing and defibrillation therapies remain available are included here.

Examples include (but are not limited to): error affecting diagnostic functions,telemetry function, data storage; malfunction of a component that causes thebattery to lose power quickly enough to result in premature battery depletion, butslowly enough that the condition is detected through normal follow-up before therapyis lost; mechanical problems with connector header that do not affect therapy.

Categorization of Normal Battery Depletion for Survival Probability ReportingPer the AdvaMed Industry Guidance for Uniform Reporting of Clinical Performanceof Pulse Generators and Leads, Normal Battery Depletion is defined as thecondition when

a) A device is returned with no associated complaint and the device has reachedits elective replacement indicator(s) with implant time that meets or exceedsthe nominal (50 percentile) predicted longevity at default (labeled) settings, or

b) A device is returned and the device has reached its elective replacementindicator(s) with implant time exceeding 75% of the expected longevity usingactual device settings and therapeutic use

Boston Scientific includes within this count both returned and non-returned devicesremoved from service for battery depletion with no associated complaint. Inconformance with the AdvaMed guidance document, Boston Scientific performsbattery usage analysis, including battery status verification, on all devices returnedwithout a complaint. We continue to include non-returned devices reported byour customers as being removed from service due to normal battery depletionwithin this count.

Boston Scientific CRM’s Corrective and Preventive Actions (CAPA) System

Boston Scientific strives to provide implantable devices of high quality and reliability.However, these devices are not perfect and may exhibit malfunctions at a low rateof occurrence. Device performance information is received from many sourcesthrough various channels. Boston Scientific monitors information from manysources including suppliers, testing, manufacturing and field performance to identifyopportunities for improvement.

When a device is returned to Boston Scientific, laboratory technicians and engineersassess overall device function and perform analysis using specific tests related tothe clinical observation(s). Test results are compared to original manufacturingrecords and design intent. Clinical observations are added to laboratory findings tohelp determine root cause of the clinical observation(s). Each discrete event isthen compared to other similar-appearing events. If a pattern is detected, actionsare taken to identify a common root cause, and improvements intended to improveproduct reliability and/or performance may be implemented. Observations fromsupplier data and internal manufacturing operations also lead to opportunities forimprovement. Improvements, when made, may include design changes in existingor subsequent generations, manufacturing and supplier process modifications,software updates, educational communications, and/or labeling changes asexamples. Improvement implementation may vary by geography due to variousfactors including regulatory review timing. They may not be applied to every productsusceptible to the malfunction pattern, and may not mitigate or eliminate thepotential for additional malfunctions. In cases where an improvement is made toan approved product line, devices made without the improvement may continue

to be distributed where such products meet our high reliability and performancestandards, particularly when changes are incremental and in accordance with ouroverall philosophy of continuous product improvement.

Improvements are closely monitored for effectiveness. Boston Scientific informsregulatory bodies of each significant event that poses potential risk to patient healthto meet regulatory obligations, and shares returned product investigation findingswith physicians. The malfunction details section for pulse generators and leadsincludes a summary of these findings.

In summary, thorough investigation of internal and external data coupled withlow trigger levels for improvements creates a continuous product improvementsystem that is very responsive to patient and physician needs. Boston Scientific iscommitted to characterizing and presenting to our customers an accurate picture ofproduct performance and addressing identified issues in a timely fashion.



TrademarksThe following are trademarks of Boston Scientific Corporation, CRM Division(doing business as Cardiac Pacemakers, Inc., a Boston Scientific Company) used inconnection with the goods or services indicated:

ACUITY ENDOTAK DSP LIVIAN

ADVANTIO ENDOTAK ENDURANCEEZ

MERIDIAN

ALTRUA ENDOTAK ENDURANCERX

PULSAR

ACT ENERGEN PUNCTUA

CHFD ENDOTAK RELIANCE SELUTE

COGNIS FINELINE SWEET PICOTIP

CONFIENT FLEXTEND SWEET TIP

CONTAK FORMIO TELIGEN

CONTAK REVEWAL INSIGNIA ULTRA I

CONTAK RENEWAL TR INGENIO VENTAK

CONTAK TR INCEPTA VENTAK PRIZM

DISCOVERY INLIVEN VITALIO

EASYTRAK INTUA VITALITY

ENDOTAK INVIVE 4–SITE

EQUIO

The following marks are registered trademarks for Intermedics, Inc (doing businessas Cardiac Pacemakers, Inc., a Boston Scientific Company) used in connection withthe goods or services indicated:

UNIPASS VIRTUS

OTHER

GORE and associated logos are trademarks of W.L. Gore & Associates.

Supporting Greater Return of Explanted DevicesThe Heart Rhythm Society (HRS) Task Force on Device Performance Policiesand Guidelines stated that knowledge, confidence, and trust in cardiac rhythmmanagement devices can be strengthened through enhancing systems thatincrease the return of devices to the manufacturer. Boston Scientific CRMshares in this belief and supports the HRS-specified actions geared towardachieving the goal of greater device return to the manufacturer, includingpost-mortem device interrogation, explantation and return to the manufacturer.1

In this section of the report, Boston Scientific provides device return rate datawith the goal of raising awareness and improving current device explant andreturn rates. Figure 2 on the following page depicts the percentage of devicesreported to have been explanted and then returned to Boston Scientific forvarious product therapy types.

Help Us Provide You With More Complete Product Performance Data

Reporting Adverse EventsThe data in this report reflect Boston Scientific’s understanding of productperformance. We acknowledge that there is underreporting. If you have productperformance observations to report, please contact your local Boston Scientificsales representative or Boston Scientific’s Technical Services department at:United States: Phone 1.800.CARDIAC (1.800.227.3422) or 1.651.582.2698.International: Please refer to the back page of this report for local contactinformation.E-mail: [email protected]

Returning Products to Boston ScientificBoston Scientific provides a Returned Products Kit (Model 6499) that includesproper forms, shipping/packaging (biohazard bags), and a prepaid shipping label.It can be ordered at no charge through Boston Scientific’s Customer Servicedepartment at 1.800.CARDIAC (1.800.227.3422) or 1.651.582.2698, or you canorder a Returned Products Kit online at www.bostonscientific.com/ppr.

1 Carlson et al. Recommendations from the Heart Rhythm Society Task Force. Heart Rhythm. October 2006; 3(special issue):1251 — 1252.



Figure 1. Percentage of U.S. explanted devices as reported and returned to Boston Scientific CRM.

0%

20%

40%

60%

80%

100%2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

(through 9/30)

Perc

ent r

etur

ned

CRT ICD Pacemakers

724 403 56%

14,244 4,543 32%

15,255 4,221 28%

1326 599 45%

15,292 5,134 34%

14,439 4,086 28%

4,507 3,085 68%

16,464 8,675 53%

21,612 10,148

47%

4,369 2,421 55%

10,190 5,240 51%

17,686 7,795 44%

4,680 2,945 63%

11,488 6,924 60%

19,009 9,053 48%

5,269 3,341 62%

15,696 9,464 60%

20,844 10,288

49%

8,125 4,787 59%

20,118 11,918

59%

21,416 10,804

50%

Explants Returns % returned Explants Returns % returned Explants Returns % returned

Explant Year

* Note: Percent return is only reported for each therapy type in years with more than 500 explants

8,967 5,633 63%

20,677 13,391

65%

21,262 11,494

54%

7,429 4,711 63%

17,485 11,542 66%

20,195 11,603 57%

4,452 2,708 61%

9,773 6,212 64%

14,107 7,810 55%

CRT-DINCEPTA CRT-D 4-Site Models N160/N162/P162

U.S. Registered Implants: 2,000

U.S. Approval Date: November 2011

U.S. Estimated Active Implants: 2,000

U.S. Normal Battery Depletions: 0

U.S. Unconfirmed Reports of PrematureBattery Depletions: 0

U.S. Confirmed Malfunctions: 0Without Compromised Therapy: 0With Compromised Therapy: 0

U.S Average Device Age: 5.9 mo.

Registered

U.S. ImplantsYr 1 (%) Yr 2 (%) Yr 3 (%) Yr 4 (%) Yr 5 (%) Yr 6 (%) Yr 7 (%) Yr 8 (%) Yr 9 (%) Yr 10 (%)

2,000 Depletions &Malfunctions

100.00 @ 10 mo.

(-0.0/+0.0)

– – – – – – – – –Non AdvisoryPopulation

MalfunctionsOnly

100.00 @ 10 mo.

(-0.0/+0.0)

– – – – – – – – –

INCEPTA CRT-D Models N161/N163/N164/N165/P163/P165








Registered



100.00 @ 10 mo.

(-0.0/+0.0)


MalfunctionsOnly

100.00 @ 10 mo.

(-0.0/+0.0)

– – – – – – – – –

9 Boston Scientific CRM Product Performance Report published March 20, 2013 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS - CRT-D

10 Boston Scientific CRM Product Performance Report published March 20, 2013U.S SURVIVAL PROBABILITY

CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS - CRT-D

ENERGEN CRT-D 4-Site Models N140/N142/P142








Registered



100.00 @ 11 mo.

(-0.0/+0.0)


MalfunctionsOnly

100.00 @ 11 mo.

(-0.0/+0.0)

– – – – – – – – –

ENERGEN CRT-D Models N141/N143/P143








Registered



99.89 @ 10 mo.

(-0.4/+0.1)


MalfunctionsOnly

99.89 @ 10 mo.

(-0.4/+0.1)

– – – – – – – – –

COGNIS Models N106/N107/N108/N118/N119/N120/P106/P107/P108


U.S. Approval Date: May 2008




U.S. Confirmed Malfunctions: 180


Registered



99.92(-0.0/+0.0)

99.85(-0.0/+0.0)

99.71(-0.2/+0.1)

– – – – – – –Non AdvisoryPopulation

MalfunctionsOnly

99.94(-0.0/+0.0)

99.89(-0.0/+0.0)

99.80(-0.2/+0.1)

– – – – – – –


99.77(-0.1+0.1)

99.63(-0.1/+0.1)

99.37(-0.1/+0.1)

98.62(-0.3/+0.2)

98.42 @ 53

(-0.5/+0.2)

– – – – –01-Dec-09SubpectoralImplant 2009* Malfunctions

Only99.80(-0.1/+0.0)

99.71(-0.1/+0.1)

99.61(-0.1/+0.1)

99.26(-0.2/+0.3)

99.20 @ 53 mo.

(-0.3/+0.2)

– – – – –

*Devices subject to an advisory. Refer to the Advisories for more details.

LIVIAN HE Models H227/H229/H247/H249


U.S. Approval Date: February 2008






Registered



99.98(-0.1/+0.0)

99.75(-0.2/+0.1)

98.90(-0.4/+0.3)

96.43(-0.8/+0.6)

91.77 @ 57 mo.

(-1.4/+1.2)

– – – – –Non AdvisoryPopulation

MalfunctionsOnly

99.98(-0.1/+0.0)

99.91(-0.1/+0.1)

99.91(-0.1/+0.1)

99.91(-0.1/+0.1)

99.91 @ 57 mo.

(-0.1/+0.1)

– – – – –




LIVIAN Models H220/H225/H240/H245








Registered



99.95(-0.1/+0.0)

99.71(-0.2/+0.1)

99.08(-0.4/+0.3)

96.35(-0.8/+0.7)

91.52 @ 57 mo.

(-1.7/+1.5)


MalfunctionsOnly

99.98(-0.1/+0.0)

99.90(-0.2/+0.1)

99.86(-0.2/+0.1)

99.82(-0.2/+0.1)

99.82 @ 57 mo.

(-0.2/+0.1)

– – – – –

CONTAK RENEWAL 3 RF HE Models H217/H219




U.S. Normal Battery Depletions: 4,306




Registered



99.93(-0.4/+0.1)

99.71(-0.5/+0.2)

98.93(-0.8/+0.4)

95.11(-1.5/+1.1)

86.31 @ 59 mo.

(-3.0/+2.5)


MalfunctionsOnly

99.93(-0.4/+0.1)

99.93(-0.4/+0.1)

99.93(-0.4/+0.1)

99.93(-0.4/+0.1)

99.93 @ 59 mo.

(-0.4/+0.1)

– – – – –


99.91(-0.1/+0.0)

99.72(-0.1/+0.1)

98.41(-0.3/+0.2)

93.89(-0.6/+0.5)

77.86(-1.0/+1.0)

32.49(-1.9/+2.0)

27.73 @ 74 mo.

(-2.1/+2.2)

– – –21-Jul-10Magnetic Reed

Switch 2010* MalfunctionsOnly

99.94(-0.1/+0.0)

99.89(-0.1/+0.0)

99.75(-0.1/+0.1)

99.43(-0.2/+0.1)

99.31(-0.2/+0.2)

99.29(-0.2/+0.2)

99.29 @ 74 mo.

(-0.2/+0.2)

– – –


99.88(-0.2/+0.1)

99.36(-0.4/+0.2)

96.77(-0.8/+0.6)

87.28(-1.5/+1.3)

55.80(-2.3/+2.3)

18.58(-1.9/+2.1)

17.07 @ 73 mo.

(-1.9/+2.1)

– – –05-Apr-07,04-Mar-09Shortened

Replacement

Window*

MalfunctionsOnly

99.91(-0.2/+0.1)

99.65(-0.3/+0.2)

98.60(-0.5/+0.4)

96.01(-0.9/+0.8)

95.18(-1.0/+0.9)

94.57(-1.4/+1.1)

93.68 @ 73 mo.

(-2.0/+1.5)

– – –


99.90(-0.1/+0.0)

99.64(-0.1/+0.1)

98.10(-0.3/+0.2)

92.71(-0.5/+0.5)

74.03(-0.9/+0.9)

30.06(-1.5/+1.5)

22.52 @ 77 mo.

(-1.6/+1.7)

– – –11-Mar-06Low Level Current*

MalfunctionsOnly

99.93(-0.1/+0.0)

99.84(-0.1/+0.1)

99.56(-0.1/+0.1)

98.94(-0.2/+0.2)

98.71(-0.2/+0.2)

98.50(-0.4/+0.3)

97.87 @ 77 mo.

(-1.0/+0.7)

– – –

*Devices subject to an advisory. Refer to the Advisories for more details. Devices may be part of more than one advisory.




CONTAK RENEWAL 3 RF Models H210/H215








Registered



99.94(-0.3/+0.0)

99.82(-0.4/+0.1)

99.17(-0.6/+0.4)

96.25(-1.2/+0.9)

90.41 @ 59 mo.

(-2.3/+1.9)


MalfunctionsOnly

99.94(-0.3/+0.0)

99.94(-0.3/+0.0)

99.94(-0.3/+0.0)

99.78(-0.5/+0.2)

99.78 @ 59 mo.

(-0.5/+0.2)

– – – – –


99.91(-0.1/+0.0)

99.75(-0.1/+0.1)

98.82(-0.2/+0.2)

95.98(-0.4/+0.4)

86.72(-0.7/+0.7)

58.50(-1.7/+1.7)

41.02 @ 76 mo.

(-2.7/+2.8)



99.96(-0.1/+0.0)

99.88(-0.1/+0.0)

99.77(-0.1/+0.1)

99.53(-0.2/+0.1)

99.28(-0.2/+0.2)

99.16(-0.3/+0.2)

99.16 @ 76 mo.

(-0.3/+0.2)

– – –


99.83(-0.2/+0.1)

99.41(-0.3/+0.2)

97.58(-0.6/+0.5)

91.88(-1.1/+1.0)

73.07(-1.9/+1.9)

31.99(-2.2/+2.3)

17.55 @ 77 mo.

(-1.9/+2.0)


Replacement

Window*

MalfunctionsOnly

99.89(-0.2/+0.1)

99.66(-0.3/+0.2)

98.82(-0.5/+0.3)

97.10(-0.7/+0.6)

94.93(-1.0/+0.9)

93.59(-1.3/+1.1)

92.77 @ 77 mo.

(-1.6/+1.4)

– – –


99.90(-0.1/+0.0)

99.67(-0.1/+0.1)

98.63(-0.2/+0.2)

95.46(-0.4/+0.4)

84.82(-0.7/+0.7)

52.42(-1.4/+1.4)

26.27 @ 79 mo.

(-2.0/+2.1)

– – –11-Mar-06Low Level Current*

MalfunctionsOnly

99.94(-0.0/+0.0)

99.84(-0.1/+0.1)

99.64(-0.1/+0.1)

99.23(-0.2/+0.1)

98.72(-0.2/+0.2)

98.37(-0.3/+0.3)

98.02 @ 79 mo.

(-0.5/+0.4)

– – –


CONTAK RENEWAL 3 HE Models H177/H179


U.S. Approval Date: June 2003






Registered



99.90(-0.6/+0.1)

99.78(-0.7/+0.2)

98.69(-1.1/+0.6)

94.17(-2.2/+1.6)

72.41(-5.0/+4.5)

68.83 @ 61 mo.

(-5.2/+4.8)

– – – –Non AdvisoryPopulation

MalfunctionsOnly

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

99.64(-1.1/+0.3)

99.64(-1.1/+0.3)

99.64 @ 61 mo.

(-1.1/+0.3)

– – – –


99.87(-0.8/+0.1)

99.38(-1.0/+0.4)

98.05(-1.6/+0.9)

94.31(-2.5/+1.7)

74.16(-4.6/+4.1)

71.10 @ 61 mo.

(-4.9/+4.4)

– – – –21-Jul-10Magnetic Reed


99.87(-0.8/+0.1)

99.72(-0.8/+0.2)

99.52(-1.0/+0.3)

99.28(-1.2/+0.5)

99.28(-1.2/+0.5)

99.28 @ 61 mo.

(-1.2/+0.5)

– – – –


99.84(-0.1/+0.1)

98.51(-0.3/+0.3)

93.47(-0.6/+0.6)

78.79(-1.1/+1.1)

46.28(-1.5/+1.5)

19.05(-1.2/+1.3)

14.26(-1.1/+1.2)

13.84 @ 86 mo.

(-1.2/+1.2)

– –05-Apr-07,04-Mar-09Shortened

Replacement

Window*

MalfunctionsOnly

99.89(-0.1/+0.1)

99.07(-0.3/+0.2)

96.98(-0.5/+0.4)

92.57(-0.8/+0.7)

88.47(-1.0/+0.9)

85.16(-1.5/+1.3)

83.92(-1.8/+1.6)

83.23 @ 86 mo.

(-2.0/+1.8)

– –


99.84(-0.1/+0.1)

99.47(-0.2/+0.1)

96.81(-0.4/+0.3)

87.33(-0.7/+0.7)

58.76(-1.2/+1.2)

24.27(-1.1/+1.2)

17.89(-1.0/+1.1)

16.35(-1.0/+1.1)

16.35 @ 101 mo.

(-1.0/+1.1)

–10-Mar-07Product Update

- Mid-life Display

of Replacement

Indicators*

MalfunctionsOnly

99.90(-0.1/+0.0)

99.78(-0.1/+0.1)

99.04(-0.2/+0.2)

97.58(-0.4/+0.3)

96.38(-0.5/+0.4)

94.26(-0.9/+0.8)

92.78(-1.2/+1.0)

91.75(-1.4/+1.2)

91.75 @ 101 mo.

(-1.4/+1.2)

–

12-May-06Premature Battery

Depletion*

<200 Survival probability data not provided because this population does not meet report inclusion criteria (see Statistical Methodology for more details). Refer to Product Advisories formore information.


99.83(-0.1/+0.1)

99.38(-0.2/+0.1)

96.73(-0.4/+0.3)

87.64(-0.7/+0.7)

59.50(-1.1/+1.1)

24.91(-1.1/+1.1)

18.21(-1.0/+1.0)

16.63(-1.0/+1.0)

16.63 @ 100 mo.

(-1.0/+1.0)

–23-Jun-05Magnetic Switch*

MalfunctionsOnly

99.88(-0.1/+0.0)

99.65(-0.1/+0.1)

98.89(-0.2/+0.2)

97.44(-0.3/+0.3)

96.09(-0.5/+0.4)

93.90(-0.8/+0.7)

92.17(-1.1/+1.0)

91.14(-1.4/+1.2)

91.14 @ 100 mo.

(-1.4/+1.2)

–





CONTAK RENEWAL 3 Models H170/H175








Registered



99.94(-0.3/+0.0)

99.72(-0.5/+0.2)

98.53(-0.9/+0.5)

95.54(-1.4/+1.1)

85.15(-2.9/+2.5)

58.84 @ 68 mo.

(-4.8/+4.6)


MalfunctionsOnly

99.94(-0.3/+0.0)

99.94(-0.3/+0.0)

99.85(-0.5/+0.1)

99.23(-0.8/+0.4)

98.83(-1.1/+0.6)

98.43 @ 68 mo.

(-1.6/+0.8)

– – – –


99.91(-0.3/+0.1)

99.43(-0.5/+0.3)

98.14(-0.8/+0.5)

94.13(-1.3/+1.1)

82.42(-2.2/+2.0)

54.82 @ 71 mo.

(-3.8/+3.7)

– – – –21-Jul-10Magnetic Reed


99.91(-0.3/+0.1)

99.54(-0.4/+0.2)

99.04(-0.6/+0.4)

98.77(-0.7/+0.4)

98.12(-0.9/+0.6)

97.70 @ 71 mo.

(-1.0/+0.7)

– – – –


99.76(-0.1/+0.1)

98.67(-0.3/+0.2)

95.23(-0.5/+0.5)

86.00(-0.9/+0.8)

64.37(-1.3/+1.2)

26.66(-1.3/+1.3)

14.57(-1.1/+1.1)

14.00 @ 87 mo.

(-1.1/+1.2)

– –05-Apr-07,04-Mar-09Shortened

Replacement

Window*

MalfunctionsOnly

99.78(-0.1/+0.1)

98.95(-0.2/+0.2)

97.13(-0.4/+0.4)

94.05(-0.6/+0.5)

90.06(-0.8/+0.8)

88.15(-1.0/+0.9)

87.76(-1.1/+1.0)

87.76 @ 87 mo.

(-1.1/+1.0)

– –


99.84(-0.1/+0.0)

99.63(-0.1/+0.1)

97.83(-0.3/+0.2)

91.12(-0.5/+0.5)

73.98(-0.8/+0.8)

33.43(-1.0/+1.0)

16.65(-0.8/+0.9)

15.41(-0.8/+0.8)

15.36 @ 105 mo.

(-0.8/+0.8)

–10-Mar-07Product Update

- Mid-life Display

of Replacement

Indicators*

MalfunctionsOnly

99.87(-0.1/+0.0)

99.79(-0.1/+0.1)

99.50(-0.1/+0.1)

98.11(-0.3/+0.2)

97.56(-0.3/+0.3)

96.86(-0.4/+0.4)

96.37(-0.5/+0.5)

96.17(-0.6/+0.5)

96.17 @ 105 mo.

(-0.6/+0.5)

–


Depletion*



99.82(-0.1/+0.0)

99.52(-0.1/+0.1)

97.65(-0.2/+0.2)

91.02(-0.5/+0.5)

74.17(-0.8/+0.8)

33.94(-0.9/+0.9)

16.55(-0.8/+0.8)

15.22(-0.8/+0.8)

15.16 @ 105 mo.

(-0.8/+0.8)

–23-Jun-05Magnetic Switch*

MalfunctionsOnly

99.85(-0.1/+0.0)

99.70(-0.1/+0.1)

99.30(-0.1/+0.1)

97.88(-0.3/+0.2)

97.22(-0.3/+0.3)

96.54(-0.4/+0.3)

96.08(-0.5/+0.4)

95.90(-0.6/+0.5)

95.90 @ 105 mo.

(-0.6/+0.5)

–


CRT-PCONTAK RENEWAL TR Models H120/H125


U.S. Approval Date: January 2004






Registered



99.90(-0.1/+0.0)

99.41(-0.2/+0.1)

98.31(-0.3/+0.2)

95.90(-0.5/+0.4)

90.59(-0.9/+0.8)

81.10(-1.5/+1.4)

67.41(-2.3/+2.2)

48.53(-3.2/+3.2)

46.93 @ 97 mo.

(-3.3/+3.4)

–Non AdvisoryPopulation

MalfunctionsOnly

99.97(-0.0/+0.0)

99.93(-0.1/+0.0)

99.84(-0.1/+0.1)

99.80(-0.1/+0.1)

99.62(-0.2/+0.1)

99.40(-0.3/+0.2)

99.15(-0.5/+0.3)

98.47(-1.1/+0.7)

98.00 @ 97 mo.

(-1.7/+0.9)

–

23-Jun-06,24-Aug-06Low Voltage

Capacitor*

200 Survival probability data not provided because this population does not meet report inclusion criteria (see Statistical Methodology for more details). Refer to Product Advisories formore information.




CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS - CRT LEAD

CRT LeadACUITY Spiral Models 4591/4592/4593




U.S. Unconfirmed Reports ofLead Complications: 188



Registered


Non AdvisoryPopulation

15,000 98.47(-0.2/+0.2)

98.09(-0.3/+0.2)

97.82(-0.3/+0.3)

97.53(-0.4/+0.3)

97.53 @ 54 mo.

(-0.4/+0.3)

– – – – –

ACUITY Spiral Longitude Models 4591/4592/4593

Leads Enrolled: 1054

Leads Active: 860

Cumulative Followup Months:25,646

ChronicLead Complications: 12

Confirmed Malfunctions: 9Without Compromised Therapy: 0With Compromised Therapy: 9

Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 Yr 6 Yr 7 Yr 8 Yr 9 Yr 10

SurvivalProbability(%)(confidence interval)

98.02(-1.1/+0.7)

97.73(-1.2/+0.8)

97.73(-1.2/+0.8)

97.73 @ 38 mo.

(-1.2/+0.8)

– – – – – –

EffectiveSample Size

753 443 126 65 – – – – – –

ACUITY Steerable Models 4554/4555/4556


U.S. Approval Date: April 2007





Registered



23,000 98.44(-0.2/+0.2)

98.04(-0.2/+0.2)

97.73(-0.2/+0.2)

97.52(-0.3/+0.2)

97.02(-0.4/+0.4)

96.96 @ 66 mo.

(-0.4/+0.4)

– – – –

EASYTRAK 3 Models 4522/4524/4525/4527/4548/4549/4550







Registered



19,000 98.65(-0.2/+0.2)

98.45(-0.2/+0.2)

98.20(-0.2/+0.2)

97.84(-0.3/+0.2)

97.38(-0.3/+0.3)

97.02(-0.4/+0.3)

96.55(-0.4/+0.4)

96.48(-0.5/+0.4)

96.48 @ 99 mo.

(-0.5/+0.4)

–

EASYTRAK 2 Models 4515/4517/4518/4520/4542/4543/4544


U.S. Approval Date: August 2004


U.S. Unconfirmed Reports ofLead Complications: 1,375



Registered



84,000 98.76(-0.1/+0.1)

98.29(-0.1/+0.1)

97.85(-0.1/+0.1)

97.48(-0.1/+0.1)

96.94(-0.2/+0.1)

96.28(-0.2/+0.2)

95.77(-0.2/+0.2)

95.51(-0.3/+0.3)

95.45 @ 101 mo.

(-0.3/+0.3)

–

EASYTRAK Models 4510/4511/4512/4513/4535/4536/4537/4538







Registered



38,000 98.94(-0.1/+0.1)

98.57(-0.1/+0.1)

98.15(-0.2/+0.1)

97.84(-0.2/+0.2)

97.36(-0.2/+0.2)

97.00(-0.2/+0.2)

96.73(-0.2/+0.2)

96.32(-0.3/+0.3)

96.07(-0.3/+0.3)

95.93(-0.3/+0.3)

19 Boston Scientific CRM Product Performance Report published March 20, 2013 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS - CRT LEAD


TACHYCARDIA THERAPY - ICD

ICDINCEPTA ICD VR 4-Site Models E160/F160








Registered



99.85 @ 10 mo.

(-0.9/+0.1)


MalfunctionsOnly

99.85 @ 10 mo.

(-0.9/+0.1)

– – – – – – – – –

INCEPTA ICD DR 4-Site Models E162/F162








Registered



100.00 @ 11 mo.

(-0.0/+0.0)


MalfunctionsOnly

100.00 @ 11 mo.

(-0.0/+0.0)

– – – – – – – – –

ENERGEN ICD VR 4-Site Models E140/F140








Registered



100.00 @ 11 mo.

(-0.0/+0.0)


MalfunctionsOnly

100.00 @ 11 mo.

(-0.0/+0.0)

– – – – – – – – –

ENERGEN ICD DR 4-Site Models E142/F142








Registered



99.92 @ 11 mo.

(-0.2/+0.1)


MalfunctionsOnly

99.92 @ 11 mo.

(-0.2/+0.1)

– – – – – – – – –

21 Boston Scientific CRM Product Performance Report published March 20, 2013 TACHYCARDIA THERAPY - ICD



ENERGEN ICD DR Models E143/F143








Registered



100.00 @ 10 mo.

(-0.0/+0.0)


MalfunctionsOnly

100.00 @ 10 mo.

(-0.0/+0.0)

– – – – – – – – –

TELIGEN VR Models E102/E103/F102/F103








Registered



99.92(-0.1/+0.0)

99.85(-0.1/+0.1)

99.77 @ 35 mo.

(-0.2/+0.1)


MalfunctionsOnly

99.94(-0.0/+0.0)

99.93(-0.0/+0.0)

99.88 @ 35 mo.

(-0.1/+0.1)

– – – – – – –


99.77(-0.1/+0.1)

99.65(-0.1/+0.1)

99.50(-0.1/+0.1)

98.90(-0.3/+0.2)

98.71 @ 53

(-0.3/+0.2)

– – – – –01–Dec-09Subpectoral Implant

2009*MalfunctionsOnly

99.80(-0.1/+0.1)

99.73(-0.1/+0.1)

99.63(-0.1/+0.1)

99.18 @ 49 mo.

(-0.2/+0.2)

98.98 @ 53

(-0.2/+0.2)

– – – – –


TELIGEN DR Models E110/E111/F110/F111








Registered



99.92(-0.0/+0.0)

99.85(-0.1/+0.0)

99.76(-0.2/+0.1)


MalfunctionsOnly

99.95(-0.0/+0.0)

99.92(-0.0/+0.0)

99.84(-0.2/+0.1)

– – – – – – –


99.88(-0.1/+0.0)

99.76(-0.1/+0.1)

99.61(-0.1/+0.1)

99.15(-0.2/+0.2)

99.15 @ 53 mo.

(-0.2/+0.2)

– – – – –01–Dec-09Subpectoral Implant

2009* MalfunctionsOnly

99.89(-0.1/+0.0)

99.82(-0.1/+0.0)

99.74(-0.1/+0.1)

99.37(-0.2/+0.1)

99.37 @ 53 mo.

(-0.2/+0.1)

– – – – –


CONFIENT DR Models E030/F030








Registered



99.94(-0.1/+0.0)

99.89(-0.1/+0.1)

99.74(-0.2/+0.1)

99.51(-0.3/+0.2)

99.33 @ 57 mo.

(-0.4/+0.2)


MalfunctionsOnly

99.98(-0.1/+0.0)

99.98(-0.1/+0.0)

99.98(-0.1/+0.0)

99.91(-0.2/+0.1)

99.87 @ 57 mo.

(-0.2/+0.1)

– – – – –




VITALITY 2 EL VR Model T177


U.S. Approval Date: March 2004






Registered



99.95(-0.2/+0.0)

99.92(-0.2/+0.1)

99.78(-0.2/+0.1)

99.42(-0.4/+0.2)

97.03(-0.9/+0.7)

61.22(-4.0/+3.8)

57.16 @ 74 mo.

(-4.2/+4.1)

– – –Non AdvisoryPopulation

MalfunctionsOnly

99.95(-0.2/+0.0)

99.92(-0.2/+0.1)

99.85(-0.2/+0.1)

99.73(-0.3/+0.1)

98.43(-0.7/+0.5)

70.98(-3.9/+3.7)

68.10 @ 74 mo.

(-4.2/+3.9)

– – –


99.95(-0.3/+0.0)

99.56(-0.5/+0.2)

98.48(-0.8/+0.5)

95.88(-1.2/+1.0)

85.72(-2.2/+2.0)

61.11(-3.2/+3.2)

46.02 @ 81 mo.

(-3.6/+3.6)


Replacement

Window*

MalfunctionsOnly

99.95(-0.3/+0.0)

99.56(-0.5/+0.2)

98.84(-0.7/+0.4)

97.00(-1.1/+0.8)

88.94(-2.1/+1.8)

68.98(-3.2/+3.0)

62.05 @ 81 mo.

(-3.5/+3.4)

– – –


99.72(-0.6/+0.2)

99.72(-0.6/+0.2)

99.48(-0.7/+0.3)

98.90(-1.0/+0.5)

91.25(-2.5/+2.0)

50.72(-4.4/+4.4)

45.58 @ 74 mo.

(-4.4/+4.4)

– – –10-Mar-07Product Update

- Mid-life Display

of Replacement

Indicators*

MalfunctionsOnly

99.72(-0.6/+0.2)

99.72(-0.6/+0.2)

99.48(-0.7/+0.3)

98.90(-1.0/+0.5)

93.23(-2.3/+1.7)

60.00(-4.5/+4.4)

54.89 @ 74 mo.

(-4.7/+4.6)

– – –


Capacitor*



VITALITY 2 EL DR Model T167








Registered



99.98(-0.1/+0.0)

99.85(-0.2/+0.1)

99.66(-0.2/+0.1)

99.00(-0.4/+0.3)

90.60(-1.3/+1.1)

80.50(-2.2/+2.1)

77.82 @ 76 mo.

(-2.9/+2.6)


MalfunctionsOnly

99.98(-0.1/+0.0)

99.90(-0.2/+0.1)

99.82(-0.2/+0.1)

99.49(-0.3/+0.2)

92.87(-1.2/+1.0)

86.91(-1.8/+1.6)

86.65 @ 76 mo.

(-1.9/+1.7)

– – –


99.94(-0.4/+0.1)

99.22(-0.6/+0.3)

98.37(-0.8/+0.5)

93.39(-1.5/+1.2)

77.47(-2.6/+2.4)

57.97(-3.2/+3.1)

39.05 @ 81 mo.

(-3.5/+3.6)


Replacement

Window*

MalfunctionsOnly

99.94(-0.4/+0.1)

99.41(-0.5/+0.3)

98.63(-0.7/+0.5)

94.61(-1.4/+1.1)

83.60(-2.4/+2.1)

75.91(-2.8/+2.6)

74.21 @ 81 mo.

(-3.0/+2.8)

– – –


99.68(-0.5/+0.2)

99.40(-0.7/+0.3)

99.18(-0.8/+0.4)

96.23(-1.5/+1.1)

74.33(-3.3/+3.1)

58.01(-3.8/+3.7)

42.69 @ 82 mo.

(-4.0/+4.1)


- Mid-life Display

of Replacement

Indicators*

MalfunctionsOnly

99.92(-0.5/+0.1)

99.74(-0.6/+0.2)

99.52(-0.7/+0.3)

97.51(-1.3/+0.9)

81.31(-3.1/+2.7)

71.25(-3.7/+3.4)

71.01 @ 82 mo.

(-3.7/+3.5)

– – –


Capacitor*






VITALITY 2 VR Model T175






U.S. Confirmed Malfunctions: 1,223Without Compromised Therapy: 1,198With Compromised Therapy: 25


Registered



99.95(-0.1/+0.0)

99.81(-0.1/+0.1)

99.48(-0.2/+0.1)

97.49(-0.4/+0.4)

93.15(-0.7/+0.6)

85.43(-1.7/+1.5)

76.77 @ 77 mo.

(-3.3/+3.0)


MalfunctionsOnly

99.97(-0.1/+0.0)

99.92(-0.1/+0.0)

99.79(-0.1/+0.1)

98.37(-0.3/+0.3)

96.00(-0.6/+0.5)

95.71(-0.6/+0.5)

95.71 @ 77 mo.

(-0.6/+0.5)

– – –


99.93(-0.1/+0.0)

99.43(-0.3/+0.2)

97.47(-0.5/+0.4)

90.30(-1.0/+0.9)

78.10(-1.4/+1.3)

52.77(-1.8/+1.8)

19.98 @ 83 mo.

(-1.8/+2.0)


Replacement

Window*

MalfunctionsOnly

99.97(-0.1/+0.0)

99.50(-0.2/+0.2)

97.79(-0.5/+0.4)

92.41(-0.9/+0.8)

86.41(-1.2/+1.1)

84.95(-1.3/+1.2)

83.13 @ 83 mo.

(-1.6/+1.5)

– – –


99.34(-0.3/+0.2)

96.85(-0.6/+0.5)

94.72(-0.8/+0.7)

86.62(-1.3/+1.2)

76.44(-1.7/+1.6)

56.43(-2.1/+2.1)

16.57(-1.7/+1.9)

14.37 @ 85 mo.

(-1.7/+1.8)

– –10-Mar-07Product Update

- Mid-life Display

of Replacement

Indicators*

MalfunctionsOnly

99.39(-0.3/+0.2)

96.95(-0.6/+0.5)

95.13(-0.8/+0.7)

89.21(-1.2/+1.1)

84.05(-1.4/+1.3)

83.39(-1.5/+1.4)

81.64(-1.8/+1.7)

81.64 @ 85 mo.

(-1.8/+1.7)

– –


99.47(-1.1/+0.4)

98.64(-1.5/+0.7)

96.88(-2.1/+1.3)

92.79(-3.1/+2.2)

77.95(-4.9/+4.3)

73.48 @ 63 mo.

(-5.3/+4.7)

– – – –23-Jun-06,24-Aug-06Low Voltage

Capacitor* MalfunctionsOnly

99.82(-1.1/+0.2)

98.99(-1.4/+0.6)

97.73(-1.9/+1.0)

95.08(-2.7/+1.8)

84.96(-4.5/+3.6)

84.53 @ 63 mo.

(-4.5/+3.6)

– – – –


Depletion*



VITALITY 2 DR Model T165








Registered



99.92(-0.1/+0.0)

99.80(-0.1/+0.1)

99.59(-0.1/+0.1)

98.53(-0.2/+0.2)

93.21(-0.6/+0.6)

54.92(-2.1/+2.1)

36.78 @ 75 mo.

(-2.9/+2.9)


MalfunctionsOnly

99.95(-0.0/+0.0)

99.89(-0.1/+0.0)

99.80(-0.1/+0.1)

99.51(-0.1/+0.1)

99.37(-0.2/+0.1)

99.17(-0.3/+0.2)

99.17 @ 75 mo.

(-0.3/+0.2)

– – –


99.86(-0.1/+0.1)

99.39(-0.2/+0.2)

96.63(-0.5/+0.4)

85.54(-0.9/+0.9)

60.70(-1.4/+1.4)

18.36(-1.2/+1.2)

7.18 @ 77 mo.

(-0.8/+0.9)


Replacement

Window*

MalfunctionsOnly

99.92(-0.1/+0.0)

99.56(-0.2/+0.1)

97.37(-0.4/+0.4)

91.22(-0.8/+0.7)

86.79(-1.0/+0.9)

84.79(-1.2/+1.1)

84.21 @ 77 mo.

(-1.5/+1.4)

– – –


99.30(-0.3/+0.2)

98.16(-0.4/+0.3)

96.36(-0.6/+0.5)

89.37(-1.0/+0.9)

73.20(-1.6/+1.5)

23.00(-1.6/+1.7)

9.77 @ 76 mo.

(-1.2/+1.3)


- Mid-life Display

of Replacement

Indicators*

MalfunctionsOnly

99.34(-0.3/+0.2)

98.28(-0.4/+0.3)

96.83(-0.6/+0.5)

92.37(-0.9/+0.8)

91.28(-1.0/+0.9)

89.34(-1.2/+1.1)

88.00 @ 76 mo.

(-1.8/+1.6)

– – –


99.84(-1.0/+0.1)

99.42(-1.2/+0.4)

98.25(-1.7/+0.9)

89.37(-3.5/+2.7)

65.65 @ 59 mo.

(-5.3/+5.0)

– – – – –23-Jun-06,24-Aug-06Low Voltage


99.84(-1.0/+0.1)

99.63(-1.1/+0.3)

98.69(-1.6/+0.7)

94.80(-2.8/+1.8)

86.96 @ 59 mo.

(-4.3/+3.3)

– – – – –


Depletion*






VITALITY DR HE Model T180








Registered



99.96(-0.3/+0.0)

99.86(-0.3/+0.1)

99.76(-0.3/+0.1)

98.27(-0.8/+0.5)

92.73(-1.6/+1.3)

85.75(-2.5/+2.2)

76.18 @ 79 mo.

(-3.8/+3.5)


MalfunctionsOnly

99.96(-0.3/+0.0)

99.91(-0.3/+0.1)

99.86(-0.3/+0.1)

99.00(-0.6/+0.4)

96.09(-1.2/+0.9)

95.17(-1.5/+1.1)

94.63 @ 79 mo.

(-1.7/+1.3)

– – –


99.82(-0.1/+0.1)

99.73(-0.2/+0.1)

99.42(-0.2/+0.2)

98.78(-0.3/+0.3)

96.74(-0.6/+0.5)

90.69(-1.4/+1.2)

85.89 @ 76 mo.

(-2.6/+2.3)



99.82(-0.1/+0.1)

99.81(-0.1/+0.1)

99.63(-0.2/+0.1)

99.28(-0.3/+0.2)

98.60(-0.4/+0.3)

97.46(-0.8/+0.6)

96.84 @ 76 mo.

(-1.2/+0.9)

– – –


99.86(-0.2/+0.1)

99.21(-0.4/+0.3)

97.96(-0.7/+0.5)

93.66(-1.2/+1.0)

82.34(-1.9/+1.7)

65.04(-2.5/+2.4)

41.97 @ 82 mo.

(-3.1/+3.2)


Replacement

Window*

MalfunctionsOnly

99.93(-0.2/+0.1)

99.44(-0.4/+0.2)

98.51(-0.6/+0.4)

96.01(-1.0/+0.8)

89.83(-1.6/+1.4)

84.89(-2.0/+1.8)

81.09 @ 82 mo.

(-2.6/+2.3)

– – –


VITALITY AVT A155 Model A155


U.S. Approval Date: October 2003






Registered



200 Survival probability data not provided because this population does not meet report inclusion criteria (see Statistical Methodology for more details).


99.58(-1.2/+0.3)

98.81(-1.6/+0.7)

97.37(-2.2/+1.2)

91.19(-3.7/+2.7)

80.31 @ 54 mo.

(-5.1/+4.3)

– – – – –05-Apr-07,04-Mar-09Shortened

Replacement

Window*

MalfunctionsOnly

99.79(-1.3/+0.2)

99.02(-1.6/+0.6)

98.72(-1.8/+0.7)

95.47(-3.0/+1.9)

94.25 @ 54 mo.

(-3.4/+2.2)

– – – – –


99.79(-0.1/+0.1)

99.39(-0.2/+0.1)

97.59(-0.3/+0.3)

89.26(-0.7/+0.7)

71.58(-1.1/+1.1)

22.57(-1.1/+1.2)

5.47 @ 79 mo.

(-0.7/+0.8)


- Mid-life Display

of Replacement

Indicators*

MalfunctionsOnly

99.82(-0.1/+0.1)

99.46(-0.2/+0.1)

98.52(-0.3/+0.2)

94.44(-0.5/+0.5)

93.19(-0.6/+0.6)

90.87(-0.9/+0.8)

86.17 @ 79 mo.

(-2.5/+2.2)

– – –


Depletion*



99.75(-0.1/+0.1)

99.28(-0.2/+0.1)

97.43(-0.4/+0.3)

89.14(-0.7/+0.7)

71.38(-1.1/+1.1)

22.59(-1.1/+1.2)

5.50 @ 79 mo.

(-0.7/+0.7)

– – –17-Jun-05,22-Jul-05Functional Latching*

MalfunctionsOnly

99.77(-0.1/+0.1)

99.35(-0.2/+0.1)

98.40(-0.3/+0.2)

94.34(-0.5/+0.5)

93.08(-0.6/+0.6)

90.76(-0.9/+0.8)

86.18 @ 79 mo.

(-2.4/+2.1)

– – –





VITALITY AVT A135 Model A135



U.S. Estimated Active Implants: 400





Registered



200 Survival probability data not provided because this population does not meet report inclusion criteria (see Statistical Methodology for more details).


99.82(-0.1/+0.1)

99.61(-0.2/+0.1)

95.69(-0.6/+0.5)

83.11(-1.1/+1.1)

55.40(-1.6/+1.6)

11.46(-1.2/+1.3)

9.41 @ 73 mo.

(-1.1/+1.2)


- Mid-life Display

of Replacement

Indicators*

MalfunctionsOnly

99.85(-0.1/+0.1)

99.75(-0.2/+0.1)

97.31(-0.5/+0.4)

90.52(-0.9/+0.8)

85.95(-1.2/+1.1)

76.17(-2.4/+2.3)

75.13 @ 73 mo.

(-2.7/+2.5)

– – –


99.82(-0.1/+0.1)

99.61(-0.2/+0.1)

95.69(-0.6/+0.5)

83.11(-1.1/+1.1)

55.40(-1.6/+1.6)

11.46(-1.2/+1.3)

9.41 @ 73 mo.

(-1.1/+1.2)

– – –17-Jun-05,22-Jul-05Functional Latching*

MalfunctionsOnly

99.85(-0.1/+0.1)

99.75(-0.2/+0.1)

97.31(-0.5/+0.4)

90.52(-0.9/+0.8)

85.95(-1.2/+1.1)

76.17(-2.4/+2.3)

75.13 @ 73 mo.

(-2.7/+2.5)

– – –


VITALITY DS VR Model T135


U.S. Approval Date: July 2003






Registered



100.00(-0.0/+0.0)

99.94(-0.2/+0.0)

99.74(-0.3/+0.1)

97.80(-0.7/+0.5)

92.60(-1.2/+1.1)

86.15(-2.4/+2.1)

80.00 @ 75 mo.

(-3.8/+3.3)


MalfunctionsOnly

100.00(-0.0/+0.0)

99.97(-0.2/+0.0)

99.91(-0.2/+0.1)

98.67(-0.5/+0.4)

95.23(-1.0/+0.8)

95.13(-1.0/+0.8)

95.13 @ 75 mo.

(-1.0/+0.8)

– – –


99.94(-0.2/+0.0)

99.40(-0.4/+0.2)

98.02(-0.6/+0.5)

91.28(-1.2/+1.1)

79.29(-1.8/+1.7)

54.66(-2.3/+2.3)

24.45 @ 82 mo.

(-2.3/+2.5)


Replacement

Window*

MalfunctionsOnly

99.97(-0.2/+0.0)

99.46(-0.3/+0.2)

98.24(-0.6/+0.4)

93.89(-1.0/+0.9)

88.88(-1.4/+1.3)

87.11(-1.6/+1.4)

86.55 @ 82 mo.

(-1.7/+1.5)

– – –


99.76(-0.1/+0.1)

99.49(-0.2/+0.1)

98.88(-0.2/+0.2)

88.48(-0.8/+0.7)

74.53(-1.1/+1.0)

57.51(-1.3/+1.3)

21.38(-1.2/+1.3)

6.18 @ 90 mo.

(-0.8/+0.9)

– –10-Mar-07Product Update

- Mid-life Display

of Replacement

Indicators*

MalfunctionsOnly

99.84(-0.1/+0.1)

99.58(-0.1/+0.1)

99.16(-0.2/+0.2)

91.53(-0.7/+0.6)

83.15(-0.9/+0.9)

81.70(-1.0/+1.0)

80.42(-1.1/+1.1)

79.23 @ 90 mo.

(-1.5/+1.4)

– –


Capacitor*



Depletion*






VITALITY DS DR Model T125








Registered



99.95(-0.1/+0.0)

99.84(-0.2/+0.1)

99.53(-0.3/+0.2)

98.29(-0.5/+0.4)

93.60(-1.0/+0.9)

55.93(-3.4/+3.4)

49.81 @ 73 mo.

(-3.7/+3.7)


MalfunctionsOnly

99.98(-0.1/+0.0)

99.98(-0.1/+0.0)

99.86(-0.2/+0.1)

99.57(-0.3/+0.2)

99.37(-0.3/+0.2)

99.02(-0.8/+0.5)

99.02 @ 73 mo.

(-0.8/+0.5)

– – –


99.78(-0.2/+0.1)

98.97(-0.4/+0.3)

96.16(-0.7/+0.6)

87.06(-1.2/+1.1)

60.71(-1.9/+1.8)

17.87(-1.6/+1.7)

10.84 @ 75 mo.

(-1.3/+1.5)


Replacement

Window*

MalfunctionsOnly

99.82(-0.2/+0.1)

99.24(-0.3/+0.2)

97.09(-0.6/+0.5)

92.09(-1.0/+0.9)

87.90(-1.3/+1.2)

84.96(-1.7/+1.6)

84.96 @ 75 mo.

(-1.7/+1.6)

– – –


99.85(-0.1/+0.1)

99.45(-0.2/+0.1)

98.01(-0.3/+0.3)

89.14(-0.7/+0.7)

76.08(-1.0/+1.0)

29.64(-1.2/+1.2)

4.77 @ 80 mo.

(-0.6/+0.7)


- Mid-life Display

of Replacement

Indicators*

MalfunctionsOnly

99.87(-0.1/+0.1)

99.56(-0.1/+0.1)

98.52(-0.3/+0.2)

92.36(-0.6/+0.6)

90.70(-0.7/+0.6)

88.49(-0.8/+0.8)

86.40 @ 80 mo.

(-1.7/+1.5)

– – –


Capacitor*



Depletion*



VITALITY EL Model T127








Registered



99.68(-0.7/+0.2)

99.55(-0.8/+0.3)

99.55(-0.8/+0.3)

98.70(-1.2/+0.6)

87.42(-3.5/+2.8)

80.03 @ 65 mo.

(-4.5/+3.9)


MalfunctionsOnly

99.89(-0.7/+0.1)

99.76(-0.7/+0.2)

99.76(-0.7/+0.2)

99.76(-0.7/+0.2)

91.11(-3.2/+2.4)

85.55 @ 65 mo.

(-4.2/+3.4)

– – – –


99.63(-1.1/+0.3)

99.21(-1.3/+0.5)

98.21(-1.8/+0.9)

92.36(-3.2/+2.3)

73.65(-5.2/+4.6)

71.82 @ 61 mo.

(-5.3/+4.8)

– – – –05-Apr-07,04-Mar-09Shortened

Replacement

Window*

MalfunctionsOnly

99.63(-1.1/+0.3)

99.21(-1.3/+0.5)

98.21(-1.8/+0.9)

93.18(-3.1/+2.2)

80.00(-4.9/+4.2)

78.80 @ 61 mo.

(-5.1/+4.3)

– – – –


99.82(-0.3/+0.1)

99.60(-0.4/+0.2)

99.36(-0.5/+0.3)

96.68(-1.1/+0.8)

63.87(-2.8/+2.7)

45.95(-3.0/+3.0)

29.32 @ 83 mo.

(-2.9/+3.1)


- Mid-life Display

of Replacement

Indicators*

MalfunctionsOnly

99.82(-0.3/+0.1)

99.65(-0.4/+0.2)

99.60(-0.4/+0.2)

97.27(-1.0/+0.7)

69.90(-2.7/+2.6)

60.00(-3.0/+3.0)

58.37 @ 83 mo.

(-3.1/+3.1)

– – –


Capacitor*






VENTAK PRIZM 2 VR Model 1860








Registered



99.84(-0.1/+0.0)

99.62(-0.1/+0.1)

99.35(-0.1/+0.1)

98.91(-0.2/+0.1)

98.12(-0.2/+0.2)

95.92(-0.4/+0.3)

88.98(-0.6/+0.6)

43.32(-1.1/+1.1)

4.73 @ 105 mo.

(-0.5/+0.6)

–Non AdvisoryPopulation

MalfunctionsOnly

99.91(-0.0/+0.0)

99.83(-0.1/+0.0)

99.75(-0.1/+0.1)

99.64(-0.1/+0.1)

99.53(-0.1/+0.1)

99.34(-0.1/+0.1)

99.22(-0.2/+0.1)

98.98(-0.2/+0.2)

98.74 @ 105 mo.

(-0.4/+0.3)

–


Capacitor*



VENTAK PRIZM 2 DR Model 1861








Registered



99.77(-0.1/+0.1)

99.54(-0.1/+0.1)

99.09(-0.2/+0.1)

98.28(-0.2/+0.2)

94.43(-0.4/+0.4)

74.90(-0.9/+0.9)

25.49(-1.0/+1.0)

5.59(-0.6/+0.7)

– –Non AdvisoryPopulation

MalfunctionsOnly

99.83(-0.1/+0.0)

99.72(-0.1/+0.1)

99.60(-0.1/+0.1)

99.45(-0.1/+0.1)

99.30(-0.2/+0.1)

99.12(-0.2/+0.2)

98.47(-0.4/+0.3)

97.87(-1.0/+0.7)

– –


99.81(-0.1/+0.1)

99.59(-0.1/+0.1)

98.83(-0.2/+0.2)

96.62(-0.3/+0.3)

89.63(-0.7/+0.6)

67.36(-1.2/+1.2)

24.53(-1.2/+1.3)

13.42(-1.0/+1.1)

12.49(-1.0/+1.1)

12.12 @ 115 mo.

(-1.0/+1.1)

17-Jun-05Shorting In Header*

MalfunctionsOnly

99.92(-0.1/+0.0)

99.85(-0.1/+0.0)

99.65(-0.1/+0.1)

99.41(-0.1/+0.1)

99.08(-0.2/+0.2)

98.74(-0.3/+0.2)

98.29(-0.4/+0.3)

98.29(-0.4/+0.3)

98.29(-0.4/+0.3)

98.29 @ 115 mo.

(-0.4/+0.3)


Capacitor*



Defibrillation LeadENDOTAK RELIANCE G 4-Site Dual Coil, Active Fixation Models 0295/0296







Registered



13,000 99.83(-0.1/+0.1)

– – – – – – – – –

ENDOTAK RELIANCE SG 4-Site Single Coil, Active Fixation Models 0292/0293







Registered



6,000 99.75 @ 11 mo.

(-0.3/+0.1)

– – – – – – – – –

ENDOTAK RELIANCE G Dual Coil, Active Fixation Models 0164/0165/0166/0167/0184/0185/0186/0187







Registered



183,000 99.78(-0.0/+0.0)

99.66(-0.0/+0.0)

99.57(-0.0/+0.0)

99.45(-0.0/+0.0)

99.29(-0.1/+0.1)

99.11(-0.1/+0.1)

98.97(-0.1/+0.1)

98.76(-0.1/+0.1)

98.63 @ 105 mo.

(-0.2/+0.2)

–

35 Boston Scientific CRM Product Performance Report published March 20, 2013 TACHYCARDIA THERAPY - DEFIBRILLATION LEAD


TACHYCARDIA THERAPY - DEFIBRILLATION LEAD

ENDOTAK RELIANCE G Dual Coil, Active Fixation Longitude Models 0164/0165/0166/0167/0184/0185/0186/0187

Leads Enrolled: 593

Leads Active: 490






100.00(-0.0/+0.0)

99.51(-1.4/+0.4)

99.51(-1.4/+0.4)

99.51 @ 45 mo.

(-1.4/+0.4)

– – – – – –


492 339 138 50. – – – – – –

ENDOTAK RELIANCE G Dual Coil, Passive Fixation Models 0174/0175/0176/0177







Registered



13,000 99.72(-0.1/+0.1)

99.58(-0.1/+0.1)

99.38(-0.2/+0.1)

99.22(-0.2/+0.2)

98.93(-0.3/+0.2)

98.67(-0.3/+0.3)

98.22(-0.5/+0.4)

97.95(-0.6/+0.5)

97.95 @ 103 mo.

(-0.6/+0.5)

–

ENDOTAK RELIANCE SG Single Coil, Active Fixation Models 0160/0161/0162/0180/0181/0182







Registered



22,000 99.67(-0.1/+0.1)

99.41(-0.1/+0.1)

99.25(-0.2/+0.1)

98.95(-0.2/+0.2)

98.70(-0.3/+0.3)

98.21(-0.5/+0.4)

98.21(-0.5/+0.4)

98.21 @ 94 mo.

(-0.5/+0.4)

– –

ENDOTAK RELIANCE Dual Coil, Active Fixation Models 0157/0158/0159







Registered



97,000 99.84(-0.0/+0.0)

99.78(-0.0/+0.0)

99.68(-0.0/+0.0)

99.57(-0.1/+0.0)

99.47(-0.1/+0.1)

99.33(-0.1/+0.1)

99.13(-0.1/+0.1)

98.97(-0.1/+0.1)

98.83(-0.1/+0.1)

98.79(-0.1/+0.1)

ENDOTAK RELIANCE Dual Coil, Passive Fixation Models 0147/0148/0149







Registered



33,000 99.80(-0.1/+0.0)

99.74(-0.1/+0.1)

99.61(-0.1/+0.1)

99.46(-0.1/+0.1)

99.26(-0.1/+0.1)

99.09(-0.1/+0.1)

98.89(-0.2/+0.1)

98.68(-0.2/+0.2)

98.56(-0.2/+0.2)

98.45(-0.2/+0.2)

ENDOTAK RELIANCE S Single Coil, Active Fixation Models 0137/0138







Registered



2,000 99.80(-0.3/+0.1)

99.67(-0.4/+0.2)

99.58(-0.5/+0.2)

99.48(-0.5/+0.3)

99.34(-0.7/+0.3)

99.02(-0.9/+0.5)

99.02(-0.9/+0.5)

99.02(-0.9/+0.5)

98.66 @ 107 mo.

(-1.4/+0.7)

–




ENDOTAK RELIANCE S Single Coil, Passive Fixation Models 0127/0128







Registered



1,000 99.66(-1.0/+0.3)

99.66(-1.0/+0.3)

99.66(-1.0/+0.3)

99.42(-1.2/+0.4)

99.42(-1.2/+0.4)

99.42(-1.2/+0.4)

99.02(-1.8/+0.6)

99.02 @ 94 mo.

(-1.8/+0.6)

– –

ENDOTAK ENDURANCE EZ Active Fixation Models 0154/0155/0156







Registered



29,000 99.81(-0.1/+0.0)

99.66(-0.1/+0.1)

99.50(-0.1/+0.1)

99.26(-0.1/+0.1)

99.01(-0.1/+0.1)

98.66(-0.2/+0.2)

98.14(-0.2/+0.2)

97.73(-0.2/+0.2)

97.31(-0.3/+0.3)

96.97(-0.3/+0.3)

ENDOTAK ENDURANCE Rx Passive Fixation Steroid Eluting Models 0144/0145/0146


U.S. Approval Date: January 1999





Registered



18,000 99.81(-0.1/+0.1)

99.61(-0.1/+0.1)

99.26(-0.2/+0.1)

98.65(-0.2/+0.2)

97.92(-0.3/+0.2)

97.39(-0.3/+0.3)

96.86(-0.3/+0.3)

96.26(-0.4/+0.4)

95.65(-0.4/+0.4)

94.74(-0.5/+0.5)

ENDOTAK ENDURANCE Passive Fixation Models 0134/0135/0136







Registered



3,000 99.53(-0.4/+0.2)

99.35(-0.4/+0.3)

98.98(-0.5/+0.3)

98.57(-0.6/+0.4)

98.12(-0.7/+0.5)

97.68(-0.8/+0.6)

97.17(-0.9/+0.7)

96.60(-1.1/+0.8)

95.96(-1.2/+0.9)

95.09(-1.4/+1.1)

ENDOTAK DSP Passive Fixation Models 0094/0095/0125







Registered



16,000 99.76(-0.1/+0.1)

99.58(-0.1/+0.1)

99.39(-0.2/+0.1)

99.10(-0.2/+0.2)

98.47(-0.3/+0.2)

98.05(-0.3/+0.3)

97.70(-0.3/+0.3)

97.33(-0.4/+0.3)

96.95(-0.4/+0.4)

96.60(-0.4/+0.4)

19-Jul-99"Long" IS-1 Terminal Pin*

21,000 99.66(-0.1/+0.1)

99.22(-0.1/+0.1)

98.60(-0.2/+0.2)

97.74(-0.2/+0.2)

96.62(-0.3/+0.3)

96.01(-0.3/+0.3)

95.19(-0.4/+0.4)

94.70(-0.4/+0.4)

94.05(-0.5/+0.4)

93.37(-0.5/+0.5)


ENDOTAK PLUS Passive Fixation Models 0073/0075/0113/0115







Registered



4,000 99.48(-0.3/+0.2)

98.76(-0.4/+0.3)

97.98(-0.5/+0.4)

96.19(-0.7/+0.6)

94.48(-0.9/+0.8)

93.80(-1.0/+0.8)

93.38(-1.0/+0.9)

92.69(-1.1/+1.0)

91.67(-1.2/+1.1)

89.88(-1.4/+1.3)




ENDOTAK 70 SERIES Passive Fixation Models 0070/0072/0074







Registered



7,000 99.46(-0.2/+0.2)

98.63(-0.3/+0.3)

97.73(-0.4/+0.4)

96.64(-0.6/+0.5)

95.64(-0.6/+0.6)

95.06(-0.7/+0.6)

94.49(-0.8/+0.7)

93.41(-0.9/+0.8)

92.41(-1.0/+0.9)

91.46(-1.1/+1.0)

ENDOTAK 60 SERIES Passive Fixation Models 0060/0062/0064







Registered



12,000 99.57(-0.1/+0.1)

98.85(-0.2/+0.2)

97.79(-0.3/+0.3)

96.14(-0.4/+0.4)

94.94(-0.5/+0.5)

94.18(-0.6/+0.5)

93.15(-0.6/+0.6)

91.83(-0.7/+0.7)

90.83(-0.8/+0.7)

89.67(-0.9/+0.8)

PacemakerADVANTIO DR Models J063/J066/K063/K066/K083








Registered



99.99 @ 7 mo.

(-0.1/+0.0)


MalfunctionsOnly

100.00 @ 7 mo.

(-0.0/+0.0)

– – – – – – – – –

INGENIO DR Models J173/J176/K173/K176/K183








Registered



100.00 @ 7 mo.

(-0.0/+0.0)


MalfunctionsOnly

100.00 @ 7 mo.

(-0.0/+0.0)

– – – – – – – – –

ALTRUA 60 SR Model S601








Registered



99.95(-0.0/+0.0)

99.90(-0.1/+0.0)

99.80(-0.1/+0.1)

99.65(-0.2/+0.1)

99.30 @ 54 mo.

(-0.5/+0.3)


MalfunctionsOnly

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

99.98(-0.1/+0.0)

99.98(-0.1/+0.0)

99.98 @ 54 mo.

(-0.1/+0.0)

– – – – –

41 Boston Scientific CRM Product Performance Report published March 20, 2013 BRADYCARDIA THERAPY - PACEMAKER

42 Boston Scientific CRM Product Performance Report published March 20, 2013U.S. SURVIVAL PROBABILITY

BRADYCARDIA THERAPY - PACEMAKER

ALTRUA 60 DR EL Model S606








Registered



99.98(-0.0/+0.0)

99.95(-0.0/+0.0)

99.84(-0.1/+0.1)

99.70 @ 44 mo.

(-0.3/+0.1)

– – – – – –Non AdvisoryPopulation

MalfunctionsOnly

99.99(-0.0/+0.0)

99.99(-0.0/+0.0)

99.99(-0.0/+0.0)

99.99 @ 44 mo.

(-0.0/+0.0)

– – – – – –

ALTRUA 60 DR (Downsize) Model S603








Registered



99.98(-0.0/+0.0)

99.93(-0.0/+0.0)

99.67(-0.1/+0.1)

99.07(-0.2/+0.1)

98.67 @ 55 mo.

(-0.3/+0.2)


MalfunctionsOnly

99.99(-0.0/+0.0)

99.99(-0.0/+0.0)

99.98(-0.0/+0.0)

99.97(-0.0/+0.0)

99.97 @ 55 mo.

(-0.0/+0.0)

– – – – –

ALTRUA 60 DR Model S602








Registered



99.98(-0.0/+0.0)

99.94(-0.1/+0.0)

99.84(-0.1/+0.1)

99.53(-0.2/+0.1)

99.38 @ 54 mo.

(-0.2/+0.2)


MalfunctionsOnly

99.99(-0.0/+0.0)

99.98(-0.0/+0.0)

99.98(-0.0/+0.0)

99.98(-0.0/+0.0)

99.98 @ 54 mo.

(-0.0/+0.0)

– – – – –

ALTRUA 40 SR Model S401








Registered



99.93(-0.2/+0.1)

99.93(-0.2/+0.1)

99.93(-0.2/+0.1)

99.83(-0.4/+0.1)

99.83 @ 50 mo.

(-0.4/+0.1)


MalfunctionsOnly

99.97(-0.2/+0.0)

99.97(-0.2/+0.0)

99.97(-0.2/+0.0)

99.97(-0.2/+0.0)

99.97 @ 50 mo.

(-0.2/+0.0)

– – – – –









Registered



100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00 @ 41 mo.

(-0.0/+0.0)


MalfunctionsOnly

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00 @ 41 mo.

(-0.0/+0.0)

– – – – – –

ALTRUA 40 DR (downsize) Model S403








Registered



99.98(-0.0/+0.0)

99.92(-0.1/+0.0)

99.69(-0.2/+0.1)

98.85(-0.6/+0.4)

98.58 @ 53 mo.

(-0.8/+0.5)


MalfunctionsOnly

99.99(-0.1/+0.0)

99.99(-0.1/+0.0)

99.99(-0.1/+0.0)

99.96(-0.1/+0.0)

99.96 @ 53 mo.

(-0.1/+0.0)

– – – – –




ALTRUA 40 DR Model S402








Registered



99.93(-0.4/+0.1)

99.93(-0.4/+0.1)

99.93(-0.4/+0.1)

99.57(-0.8/+0.3)

99.57 @ 52 mo.

(-0.8/+0.3)


MalfunctionsOnly

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00 @ 52 mo.

(-0.0/+0.0)

– – – – –

ALTRUA 20 SR Models S201/S204








Registered



99.95(-0.2/+0.0)

99.87(-0.2/+0.1)

99.55(-0.5/+0.2)

99.32(-0.9/+0.4)

99.32 @ 49 mo.

(-0.9/+0.4)


MalfunctionsOnly

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00 @ 49 mo.

(-0.0/+0.0)

– – – – –









Registered



99.93(-0.2/+0.1)

99.89(-0.2/+0.1)

99.74(-0.6/+0.2)

99.74 @ 40 mo.

(-0.6/+0.2)


MalfunctionsOnly

99.97(-0.2/+0.0)

99.97(-0.2/+0.0)

99.97(-0.2/+0.0)

99.97 @ 40 mo.

(-0.2/+0.0)

– – – – – –

ALTRUA 20 DR (downsize) Model S203








Registered



100.00(-0.0/+0.0)

99.93(-0.2/+0.0)

99.57(-0.4/+0.2)

98.93(-0.8/+0.5)

98.56 @ 50 mo.

(-1.3/+0.7)


MalfunctionsOnly

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00 @ 50 mo.

(-0.0/+0.0)

– – – – –

ALTRUA 20 DR Models S202/S205








Registered



100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

99.90(-0.6/+0.1)

99.54(-0.8/+0.3)

99.29 @ 51 mo.

(-1.1/+0.4)


MalfunctionsOnly

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00 @ 51 mo.

(-0.0/+0.0)

– – – – –




INSIGNIA Ultra SR Model 1190








Registered



99.97(-0.0/+0.0)

99.94(-0.1/+0.0)

99.73(-0.1/+0.1)

99.42(-0.2/+0.1)

98.73(-0.3/+0.2)

97.29(-0.5/+0.4)

91.34(-1.7/+1.4)

89.16 @ 90 mo.

(-2.4/+2.0)


MalfunctionsOnly

99.99(-0.0/+0.0)

99.99(-0.0/+0.0)

99.98(-0.1/+0.0)

99.97(-0.1/+0.0)

99.94(-0.1/+0.0)

99.88(-0.2/+0.1)

99.61(-0.6/+0.2)

99.61 @ 90 mo.

(-0.6/+0.2)

– –


99.83(-0.5/+0.1)

99.73(-0.6/+0.2)

99.51(-0.7/+0.3)

99.11(-0.9/+0.5)

98.47(-1.2/+0.7)

97.22(-1.6/+1.0)

93.90 @ 81 mo.

(-2.5/+1.8)

– – –23-Jun-06,24-Aug-06Low Voltage


99.91(-0.5/+0.1)

99.91(-0.5/+0.1)

99.91(-0.5/+0.1)

99.77(-0.7/+0.2)

99.77(-0.7/+0.2)

99.59(-0.9/+0.3)

99.59 @ 81 mo.

(-0.9/+0.3)

– – –

22-Sep-05Crystal Timing

Component (Failure

Mode 1)*



100.00(-0.0/+0.0)

99.98(-0.1/+0.0)

99.85(-0.2/+0.1)

99.27(-0.4/+0.3)

98.32(-0.6/+0.4)

96.30(-0.9/+0.7)

89.47(-1.5/+1.3)

76.38(-2.8/+2.6)

74.28 @ 98 mo.

(-3.1/+2.9)

–22-Sep-05Crystal Timing

Component (Failure

Mode 2)*MalfunctionsOnly

100.00(-0.0/+0.0)

99.98(-0.1/+0.0)

99.98(-0.1/+0.0)

99.87(-0.2/+0.1)

99.83(-0.2/+0.1)

99.78(-0.3/+0.1)

99.48(-0.4/+0.2)

99.48(-0.4/+0.2)

99.48 @ 98 mo.

(-0.4/+0.2)

–

*Devices subject to an advisory. Refer to the Advisories for more details. Devices may be part of more than one advisory.Data are representative of Boston Scientific INSIGNIA Ultra and Intermedics NEXUS Ultra device performance.

INSIGNIA Ultra DR (downsize) Model 1290








Registered



99.96(-0.0/+0.0)

99.86(-0.0/+0.0)

99.49(-0.1/+0.1)

98.55(-0.1/+0.1)

95.93(-0.2/+0.2)

87.93(-0.5/+0.5)

70.62(-1.2/+1.2)

50.49 @ 94 mo.

(-2.5/+2.5)


MalfunctionsOnly

99.99(-0.0/+0.0)

99.97(-0.0/+0.0)

99.94(-0.0/+0.0)

99.83(-0.0/+0.0)

99.62(-0.1/+0.1)

99.33(-0.1/+0.1)

99.08(-0.2/+0.2)

98.81 @ 94 mo.

(-0.4/+0.3)

– –


99.88(-0.2/+0.1)

99.75(-0.2/+0.1)

99.51(-0.3/+0.2)

98.41(-0.5/+0.4)

95.67(-0.8/+0.7)

88.26(-1.4/+1.2)

76.46 @ 82 mo.

(-2.2/+2.0)



99.95(-0.1/+0.0)

99.95(-0.1/+0.0)

99.95(-0.1/+0.0)

99.78(-0.2/+0.1)

99.37(-0.4/+0.2)

99.10(-0.5/+0.3)

98.76 @ 82 mo.

(-0.6/+0.4)

– – –


Component (Failure

Mode 1)*



99.96(-0.0/+0.0)

99.87(-0.1/+0.0)

99.38(-0.2/+0.1)

97.77(-0.3/+0.3)

93.64(-0.5/+0.5)

82.87(-0.8/+0.8)

64.76(-1.1/+1.1)

44.41(-1.5/+1.5)

37.34 @ 100 mo.

(-1.9/+2.0)


Component (Failure


99.98(-0.0/+0.0)

99.98(-0.0/+0.0)

99.95(-0.1/+0.0)

99.73(-0.1/+0.1)

99.09(-0.2/+0.2)

98.67(-0.3/+0.2)

98.46(-0.3/+0.2)

98.17(-0.5/+0.4)

98.17 @ 100 mo.

(-0.5/+0.4)

–





INSIGNIA Ultra DR Model 1291








Registered



99.98(-0.0/+0.0)

99.94(-0.0/+0.0)

99.85(-0.1/+0.0)

99.52(-0.1/+0.1)

98.73(-0.2/+0.2)

97.07(-0.4/+0.4)

94.77(-0.9/+0.8)

89.54 @ 93 mo.

(-2.5/+2.1)


MalfunctionsOnly

99.99(-0.0/+0.0)

99.97(-0.0/+0.0)

99.95(-0.0/+0.0)

99.92(-0.1/+0.0)

99.82(-0.1/+0.1)

99.72(-0.1/+0.1)

99.62(-0.2/+0.1)

99.62 @ 93 mo.

(-0.2/+0.1)

– –


99.95(-0.3/+0.0)

99.84(-0.3/+0.1)

99.64(-0.4/+0.2)

99.35(-0.6/+0.3)

98.85(-0.7/+0.4)

97.62(-1.0/+0.7)

95.86 @ 82 mo.

(-1.4/+1.0)



99.95(-0.3/+0.0)

99.95(-0.3/+0.0)

99.95(-0.3/+0.0)

99.95(-0.3/+0.0)

99.95(-0.3/+0.0)

99.95(-0.3/+0.0)

99.63 @ 82 mo.

(-0.6/+0.2)

– – –


100.00(-0.0/+0.0)

99.92(-0.1/+0.0)

99.77(-0.2/+0.1)

99.39(-0.3/+0.2)

98.55(-0.4/+0.3)

96.66(-0.7/+0.5)

93.52(-0.9/+0.8)

86.45(-1.7/+1.6)

81.68 @ 101 mo.

(-2.5/+2.3)


Component (Failure


100.00(-0.0/+0.0)

99.98(-0.1/+0.0)

99.96(-0.1/+0.0)

99.89(-0.2/+0.1)

99.78(-0.2/+0.1)

99.62(-0.3/+0.2)

99.15(-0.4/+0.3)

98.39(-0.7/+0.5)

98.39 @ 101 mo.

(-0.7/+0.5)

–


INSIGNIA Entra SR Models 1195/1198








Registered



99.90(-0.1/+0.1)

99.85(-0.2/+0.1)

99.77(-0.2/+0.1)

99.56(-0.3/+0.2)

99.37(-0.4/+0.2)

98.43(-0.8/+0.5)

97.94(-1.0/+0.7)

97.19 @ 87 mo.

(-1.7/+1.1)


MalfunctionsOnly

99.94(-0.1/+0.0)

99.94(-0.1/+0.0)

99.91(-0.1/+0.1)

99.91(-0.1/+0.1)

99.91(-0.1/+0.1)

99.91(-0.1/+0.1)

99.75(-0.7/+0.2)

99.75 @ 87 mo.

(-0.7/+0.2)

– –


99.78(-1.3/+0.2)

99.10(-1.9/+0.6)

98.39(-2.2/+0.9)

97.94(-2.5/+1.1)

– – – – – –23-Jun-06,24-Aug-06Low Voltage


99.78(-1.3/+0.2)

99.78(-1.3/+0.2)

99.78(-1.3/+0.2)

99.78(-1.3/+0.2)

– – – – – –


99.93(-0.4/+0.1)

99.84(-0.5/+0.1)

99.50(-0.7/+0.3)

99.21(-0.9/+0.4)

98.19(-1.3/+0.8)

96.96(-1.8/+1.1)

95.73(-2.1/+1.4)

94.27(-2.6/+1.8)

91.13 @ 105 mo.

(-3.5/+2.6)


Component (Failure


100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00 @ 105 mo.

(-0.0/+0.0)

–


99.98(-0.1/+0.0)

99.91(-0.2/+0.1)

99.62(-0.3/+0.2)

98.84(-0.4/+0.3)

98.04(-0.6/+0.5)

97.05(-0.7/+0.6)

95.37(-1.0/+0.8)

92.24(-1.4/+1.2)

85.60(-2.7/+2.4)


Component (Failure


100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

99.96(-0.2/+0.0)

99.96(-0.2/+0.0)

99.90(-0.3/+0.1)

99.90(-0.3/+0.1)

99.90(-0.3/+0.1)

–

*Devices subject to an advisory. Refer to the Advisories for more details. Devices may be part of more than one advisory.Data are representative of Boston Scientific INSIGNIA Entra and Intermedics NEXUS Entra device performance.




INSIGNIA Entra DR (downsize) Model 1296








Registered



99.96(-0.1/+0.0)

99.85(-0.1/+0.1)

99.43(-0.2/+0.2)

98.43(-0.4/+0.3)

96.65(-0.6/+0.5)

92.56(-1.0/+0.9)

82.27(-2.2/+2.0)

68.68 @ 93 mo.

(-3.9/+3.7)


MalfunctionsOnly

100.00(-0.0/+0.0)

99.99(-0.1/+0.0)

99.90(-0.1/+0.1)

99.80(-0.2/+0.1)

99.55(-0.2/+0.2)

99.33(-0.3/+0.2)

99.19(-0.4/+0.3)

98.90 @ 93 mo.

(-0.9/+0.5)

– –


100.00(-0.0/+0.0)

99.70(-0.9/+0.2)

99.20(-1.1/+0.5)

97.85(-1.6/+0.9)

95.63(-2.2/+1.5)

91.94(-3.0/+2.2)

87.57 @ 80 mo.

(-3.7/+2.9)



100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

99.76(-1.5/+0.2)

99.76(-1.5/+0.2)

99.44 @ 80 mo.

(-1.7/+0.4)

– – –


99.83(-0.2/+0.1)

99.79(-0.3/+0.1)

99.39(-0.4/+0.2)

98.86(-0.5/+0.4)

96.75(-0.9/+0.7)

92.07(-1.5/+1.2)

81.86(-2.2/+2.0)

64.58(-2.8/+2.7)

47.00(-3.2/+3.2)

42.67 @ 112 mo.

(-3.3/+3.3)


Component (Failure


99.90(-0.2/+0.1)

99.90(-0.2/+0.1)

99.90(-0.2/+0.1)

99.90(-0.2/+0.1)

99.84(-0.3/+0.1)

99.68(-0.4/+0.2)

99.59(-0.5/+0.2)

99.48(-0.6/+0.3)

99.48(-0.6/+0.3)

99.48 @ 112 mo.

(-0.6/+0.3)


99.98(-0.1/+0.0)

99.88(-0.1/+0.1)

99.58(-0.2/+0.1)

98.54(-0.3/+0.3)

96.48(-0.5/+0.4)

90.91(-0.8/+0.7)

79.16(-1.2/+1.1)

60.86(-1.6/+1.6)

43.98(-2.3/+2.3)

43.19 @ 109 mo.

(-2.4/+2.4)


Component (Failure


99.98(-0.1/+0.0)

99.98(-0.1/+0.0)

99.97(-0.1/+0.0)

99.83(-0.1/+0.1)

99.52(-0.2/+0.1)

99.27(-0.3/+0.2)

99.14(-0.3/+0.2)

98.87(-0.4/+0.3)

98.87(-0.4/+0.3)

98.87 @ 109 mo.

(-0.4/+0.3)


INSIGNIA Entra DR Models 1294/1295








Registered



99.97(-0.1/+0.0)

99.87(-0.1/+0.1)

99.75(-0.2/+0.1)

99.51(-0.2/+0.2)

98.66(-0.4/+0.3)

97.19(-0.7/+0.6)

95.29(-1.3/+1.0)

93.56 @ 91 mo.

(-2.2/+1.7)


MalfunctionsOnly

100.00(-0.0/+0.0)

99.97(-0.1/+0.0)

99.91(-0.1/+0.1)

99.91(-0.1/+0.1)

99.82(-0.2/+0.1)

99.78(-0.2/+0.1)

99.67(-0.4/+0.2)

99.25 @ 91 mo.

(-1.6/+0.5)

– –


100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

99.45(-1.1/+0.4)

99.24(-1.3/+0.5)

98.76(-1.5/+0.7)

97.66(-2.0/+1.1)

97.66 @ 80 mo.

(-2.0/+1.1)



100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

99.82(-1.1/+0.2)

99.61(-1.2/+0.3)

99.61(-1.2/+0.3)

99.61(-1.2/+0.3)

99.61 @ 80 mo.

(-1.2/+0.3)

– – –


99.83(-0.4/+0.1)

99.69(-0.4/+0.2)

99.46(-0.5/+0.3)

99.19(-0.7/+0.4)

98.09(-1.0/+0.7)

96.06(-1.4/+1.1)

93.81(-1.8/+1.4)

91.03(-2.2/+1.8)

86.06(-2.9/+2.5)

82.29 @ 112 mo.

(-3.5/+3.0)


Component (Failure


99.83(-0.4/+0.1)

99.83(-0.4/+0.1)

99.83(-0.4/+0.1)

99.83(-0.4/+0.1)

99.83(-0.4/+0.1)

99.83(-0.4/+0.1)

99.67(-0.6/+0.2)

99.19(-1.0/+0.5)

99.19(-1.0/+0.5)

99.19 @ 112 mo.

(-1.0/+0.5)


99.97(-0.1/+0.0)

99.90(-0.1/+0.1)

99.74(-0.2/+0.1)

99.34(-0.3/+0.2)

98.43(-0.4/+0.3)

96.95(-0.6/+0.5)

94.64(-0.8/+0.7)

91.69(-1.1/+1.0)

85.66(-2.3/+2.0)


Component (Failure


99.99(-0.1/+0.0)

99.95(-0.1/+0.0)

99.95(-0.1/+0.0)

99.91(-0.1/+0.1)

99.83(-0.2/+0.1)

99.71(-0.2/+0.1)

99.47(-0.3/+0.2)

99.35(-0.3/+0.2)

98.92(-0.7/+0.4)

–





INSIGNIA Plus SR Model 1194








Registered



99.96(-0.1/+0.0)

99.92(-0.1/+0.1)

99.61(-0.3/+0.2)

99.33(-0.3/+0.2)

98.49(-0.5/+0.4)

97.17(-0.9/+0.7)

93.49(-1.9/+1.5)

89.80 @ 89 mo.

(-3.1/+2.5)


MalfunctionsOnly

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

99.97(-0.2/+0.0)

99.97(-0.2/+0.0)

99.93(-0.2/+0.1)

99.93(-0.2/+0.1)

99.65(-0.7/+0.2)

99.65 @ 89 mo.

(-0.7/+0.2)

– –

400 Depletions &Malfunctions

100.00(-0.0/+0.0)

99.66(-2.0/+0.3)

99.27(-2.1/+0.5)

98.34 @ 45 mo.

(-2.7/+1.0)

– – – – – –23-Jun-06,24-Aug-06Low Voltage


100.00(-0.0/+0.0)

99.66(-2.0/+0.3)

99.66(-2.0/+0.3)

99.19 @ 45 mo.

(-2.4/+0.6)

– – – – – –


99.92(-0.2/+0.1)

99.89(-0.2/+0.1)

99.73(-0.3/+0.1)

99.37(-0.4/+0.2)

98.74(-0.6/+0.4)

98.00(-0.7/+0.5)

94.78(-1.2/+1.0)

84.86(-2.1/+1.9)

71.51(-2.9/+2.7)

67.06 @ 114 mo.

(-3.2/+3.0)


Component (Failure


99.92(-0.2/+0.1)

99.92(-0.2/+0.1)

99.88(-0.2/+0.1)

99.88(-0.2/+0.1)

99.88(-0.2/+0.1)

99.76(-0.3/+0.1)

99.68(-0.4/+0.2)

99.68(-0.4/+0.2)

99.68(-0.4/+0.2)

99.68 @ 114 mo.

(-0.4/+0.2)


99.95(-0.1/+0.0)

99.87(-0.1/+0.0)

99.68(-0.1/+0.1)

99.27(-0.2/+0.1)

98.54(-0.3/+0.2)

97.14(-0.4/+0.4)

92.93(-0.7/+0.6)

81.70(-1.1/+1.1)

69.61(-1.6/+1.5)

59.13(-2.1/+2.1)


Component (Failure


99.99(-0.0/+0.0)

99.99(-0.0/+0.0)

99.96(-0.1/+0.0)

99.95(-0.1/+0.0)

99.94(-0.1/+0.0)

99.91(-0.1/+0.0)

99.89(-0.1/+0.1)

99.89(-0.1/+0.1)

99.80(-0.2/+0.1)

99.80(-0.2/+0.1)

*Devices subject to an advisory. Refer to the Advisories for more details. Devices may be part of more than one advisory.Data are representative of Boston Scientific INSIGNIA Plus and Intermedics NEXUS Plus device performance.

INSIGNIA Plus DR (downsize) Model 1298








Registered



99.94(-0.1/+0.0)

99.88(-0.1/+0.0)

99.41(-0.1/+0.1)

98.29(-0.2/+0.2)

95.52(-0.4/+0.4)

87.27(-0.8/+0.8)

69.09(-1.6/+1.6)

48.41 @ 95 mo.

(-2.9/+2.9)


MalfunctionsOnly

99.98(-0.0/+0.0)

99.98(-0.0/+0.0)

99.90(-0.1/+0.0)

99.76(-0.1/+0.1)

99.53(-0.1/+0.1)

99.28(-0.2/+0.2)

99.13(-0.3/+0.2)

98.89 @ 95 mo.

(-0.5/+0.4)

– –


99.93(-0.4/+0.1)

99.86(-0.4/+0.1)

99.77(-0.5/+0.2)

98.12(-1.0/+0.7)

95.81(-1.5/+1.1)

84.91(-2.6/+2.3)

72.15 @ 81 mo.

(-3.5/+3.3)



100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

99.71(-0.6/+0.2)

99.37(-0.8/+0.3)

99.25(-0.8/+0.4)

98.92 @ 81 mo.

(-1.0/+0.5)

– – –


99.91(-0.1/+0.0)

99.65(-0.1/+0.1)

99.14(-0.2/+0.2)

98.04(-0.3/+0.2)

95.05(-0.5/+0.4)

86.20(-0.8/+0.7)

67.73(-1.1/+1.1)

47.19(-1.3/+1.3)

32.33(-1.3/+1.3)

25.39 @ 116 mo.

(-1.4/+1.5)


Component (Failure


99.93(-0.1/+0.0)

99.88(-0.1/+0.0)

99.81(-0.1/+0.1)

99.79(-0.1/+0.1)

99.57(-0.2/+0.1)

99.38(-0.2/+0.1)

99.32(-0.2/+0.2)

99.19(-0.2/+0.2)

99.14(-0.3/+0.2)

99.14 @ 116 mo.

(-0.3/+0.2)


99.96(-0.0/+0.0)

99.81(-0.0/+0.0)

99.26(-0.1/+0.1)

97.91(-0.2/+0.1)

94.49(-0.3/+0.2)

84.15(-0.4/+0.4)

64.31(-0.6/+0.6)

44.36(-0.7/+0.7)

29.89(-0.8/+0.8)

20.62(-0.9/+0.9)


Component (Failure


99.99(-0.0/+0.0)

99.96(-0.0/+0.0)

99.95(-0.0/+0.0)

99.83(-0.0/+0.0)

99.61(-0.1/+0.1)

99.39(-0.1/+0.1)

99.30(-0.1/+0.1)

99.21(-0.1/+0.1)

99.14(-0.1/+0.1)

99.14(-0.1/+0.1)





INSIGNIA Plus DR Model 1297








Registered



100.00(-0.0/+0.0)

99.98(-0.1/+0.0)

99.78(-0.2/+0.1)

99.29(-0.3/+0.2)

98.54(-0.4/+0.3)

97.10(-0.7/+0.6)

93.90(-1.5/+1.2)

90.10 @ 92 mo.

(-2.6/+2.1)


MalfunctionsOnly

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

99.96(-0.1/+0.0)

99.94(-0.1/+0.0)

99.89(-0.2/+0.1)

99.74(-0.3/+0.1)

99.19(-0.7/+0.4)

99.19 @ 92 mo.

(-0.7/+0.4)

– –


100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

99.19(-1.3/+0.5)

99.19(-1.3/+0.5)

97.25(-2.2/+1.2)

95.93 @ 80 mo.

(-2.6/+1.6)



100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

99.73(-1.6/+0.2)

99.73 @ 80 mo.

(-1.6/+0.2)

– – –


99.95(-0.2/+0.0)

99.86(-0.2/+0.1)

99.49(-0.3/+0.2)

98.96(-0.5/+0.3)

97.93(-0.7/+0.5)

96.25(-0.9/+0.7)

93.59(-1.2/+1.0)

88.30(-1.6/+1.5)

78.03(-2.3/+2.1)

70.96 @ 114 mo.

(-3.0/+2.8)


Component (Failure


99.97(-0.2/+0.0)

99.97(-0.2/+0.0)

99.94(-0.2/+0.0)

99.90(-0.2/+0.1)

99.81(-0.3/+0.1)

99.48(-0.4/+0.2)

99.42(-0.4/+0.3)

99.04(-0.6/+0.4)

98.56(-0.8/+0.5)

98.56 @ 114 mo.

(-0.8/+0.5)


99.96(-0.1/+0.0)

99.91(-0.1/+0.0)

99.59(-0.1/+0.1)

99.14(-0.2/+0.2)

98.21(-0.3/+0.3)

96.54(-0.4/+0.4)

94.12(-0.6/+0.5)

87.81(-0.9/+0.8)

77.87(-1.4/+1.3)

61.31(-2.5/+2.5)


Component (Failure


99.99(-0.0/+0.0)

99.99(-0.0/+0.0)

99.98(-0.1/+0.0)

99.94(-0.1/+0.0)

99.88(-0.1/+0.1)

99.58(-0.2/+0.1)

99.38(-0.2/+0.2)

99.05(-0.3/+0.2)

98.76(-0.4/+0.3)

98.56(-0.5/+0.4)


PULSAR MAX II SR (downsize) Model 1180








Registered



99.97(-0.1/+0.0)

99.93(-0.1/+0.0)

99.69(-0.2/+0.1)

98.99(-0.4/+0.3)

94.70(-0.8/+0.7)

72.48(-1.7/+1.6)

51.96(-2.0/+2.0)

38.75(-2.1/+2.1)

35.91(-2.1/+2.2)

34.09(-2.1/+2.2)


MalfunctionsOnly

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

99.98(-0.1/+0.0)

99.98(-0.1/+0.0)

99.91(-0.2/+0.1)

99.86(-0.3/+0.1)

99.86(-0.3/+0.1)

99.86(-0.3/+0.1)

99.86(-0.3/+0.1)

99.86(-0.3/+0.1)

21-Jan-06,18-Jul-05Hermetic Sealing

Component

(Original Pop.)*

NaN Survival probability data not provided because this population does not meet report inclusion criteria (see Statistical Methodology for more details). Refer to Product Advisories formore information.

*Devices subject to an advisory. Refer to the Advisories for more details.Data are representative of Boston Scientific PULSAR MAX II and Intermedics VIRTUS Plus II device performance.




PULSAR MAX II DR Model 1280








Registered



99.92(-0.0/+0.0)

99.71(-0.1/+0.1)

99.41(-0.1/+0.1)

98.71(-0.2/+0.1)

97.02(-0.3/+0.2)

87.42(-0.5/+0.5)

63.46(-0.8/+0.8)

39.56(-0.9/+0.9)

22.48(-0.9/+0.9)

13.45(-0.8/+0.9)


MalfunctionsOnly

99.98(-0.0/+0.0)

99.97(-0.0/+0.0)

99.94(-0.0/+0.0)

99.92(-0.0/+0.0)

99.87(-0.1/+0.0)

99.67(-0.1/+0.1)

99.23(-0.2/+0.1)

98.22(-0.3/+0.3)

96.98(-0.6/+0.5)

96.18(-0.9/+0.7)

21-Jan-06Hermetic Sealing

Component (Second

Pop.)*



Component

(Original Pop.)*


*Devices subject to an advisory. Refer to the Advisories for more details. Devices may be part of more than one advisory.Data are representative of Boston Scientific PULSAR MAX II and Intermedics VIRTUS Plus II device performance.

DISCOVERY II SR (downsize) Model 1184








Registered



99.96(-0.1/+0.0)

99.83(-0.1/+0.1)

99.65(-0.2/+0.1)

99.11(-0.3/+0.2)

98.00(-0.4/+0.3)

93.54(-0.7/+0.7)

73.09(-1.5/+1.4)

50.92(-1.8/+1.8)

44.15(-1.8/+1.9)

40.82(-1.9/+1.9)


MalfunctionsOnly

99.99(-0.0/+0.0)

99.98(-0.1/+0.0)

99.98(-0.1/+0.0)

99.98(-0.1/+0.0)

99.96(-0.1/+0.0)

99.94(-0.1/+0.0)

99.90(-0.2/+0.1)

99.90(-0.2/+0.1)

99.90(-0.2/+0.1)

99.90(-0.2/+0.1)


99.72(-1.7/+0.2)

99.72(-1.7/+0.2)

99.36(-1.9/+0.5)

98.41 @ 43 mo.

(-2.6/+1.0)

– – – – – –21-Jan-06Hermetic Sealing

Component (Second

Pop.)*MalfunctionsOnly

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00 @ 43 mo.

(-0.0/+0.0)

– – – – – –


Component

(Original Pop.)*


*Devices subject to an advisory. Refer to the Advisories for more details. Devices may be part of more than one advisory.Data are representative of Boston Scientific DISCOVERY II and Intermedics INTELIS II device performance.




DISCOVERY II SR Models 1186/1187








Registered



99.96(-0.2/+0.0)

99.78(-0.3/+0.1)

99.61(-0.4/+0.2)

99.36(-0.5/+0.3)

99.07(-0.6/+0.4)

98.44(-0.8/+0.5)

96.59(-1.3/+0.9)

93.49(-1.8/+1.5)

79.99(-3.3/+3.0)

63.87(-4.5/+4.2)


MalfunctionsOnly

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

99.86(-0.8/+0.1)

99.86(-0.8/+0.1)

99.86(-0.8/+0.1)


Component (Second

Pop.)*



Component

(Original Pop.)*



DISCOVERY II DR (downsize) Model 1283








Registered



99.90(-0.0/+0.0)

99.66(-0.1/+0.1)

98.77(-0.2/+0.1)

96.08(-0.3/+0.3)

85.78(-0.5/+0.5)

59.94(-0.8/+0.8)

38.73(-0.9/+0.9)

32.53(-0.9/+0.9)

31.20(-0.9/+0.9)

30.83(-0.9/+0.9)


MalfunctionsOnly

99.97(-0.0/+0.0)

99.97(-0.0/+0.0)

99.96(-0.0/+0.0)

99.93(-0.0/+0.0)

99.92(-0.0/+0.0)

99.87(-0.1/+0.0)

99.85(-0.1/+0.1)

99.75(-0.2/+0.1)

99.75(-0.2/+0.1)

99.75(-0.2/+0.1)


99.90(-0.6/+0.1)

99.47(-0.7/+0.3)

98.31(-1.1/+0.7)

93.73(-2.0/+1.6)

79.82(-3.4/+3.0)

57.21 @ 69 mo.

(-4.5/+4.4)

– – – –21-Jan-06Hermetic Sealing

Component (Second


100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00 @ 69 mo.

(-0.0/+0.0)

– – – –


100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

99.06(-1.5/+0.6)

94.30(-2.9/+2.0)

78.94(-4.9/+4.2)

77.77 @ 61 mo.

(-5.0/+4.3)

– – – –21-Jan-06,18-Jul-05Hermetic Sealing

Component

(Original Pop.)*

MalfunctionsOnly

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

99.57(-2.6/+0.4)

99.57 @ 61 mo.

(-2.6/+0.4)

– – – –





DISCOVERY II DR Models 1284/1286








Registered



99.96(-0.0/+0.0)

99.84(-0.1/+0.0)

99.59(-0.1/+0.1)

98.94(-0.2/+0.2)

97.49(-0.3/+0.3)

94.44(-0.4/+0.4)

83.22(-0.7/+0.7)

59.34(-1.1/+1.1)

35.72(-1.2/+1.2)

25.05(-1.2/+1.2)


MalfunctionsOnly

99.99(-0.0/+0.0)

99.99(-0.0/+0.0)

99.98(-0.0/+0.0)

99.96(-0.0/+0.0)

99.96(-0.0/+0.0)

99.95(-0.1/+0.0)

99.94(-0.1/+0.0)

99.90(-0.1/+0.1)

99.69(-0.3/+0.1)

99.60(-0.4/+0.2)


100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

99.72(-1.7/+0.2)

98.77(-2.0/+0.8)

98.04(-2.4/+1.1)

95.44 @ 67 mo.

(-3.4/+2.0)

– – – –21-Jan-06Hermetic Sealing

Component (Second


100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00 @ 67 mo.

(-0.0/+0.0)

– – – –


Component

(Original Pop.)*



PULSAR MAX DR Model 1270








Registered



99.94(-0.0/+0.0)

99.78(-0.1/+0.1)

99.38(-0.1/+0.1)

98.24(-0.2/+0.2)

95.80(-0.3/+0.3)

85.46(-0.6/+0.6)

62.15(-0.9/+0.9)

38.33(-1.0/+1.0)

23.22(-0.9/+1.0)

14.28(-0.9/+0.9)


MalfunctionsOnly

99.98(-0.0/+0.0)

99.96(-0.0/+0.0)

99.95(-0.0/+0.0)

99.93(-0.0/+0.0)

99.91(-0.1/+0.0)

99.84(-0.1/+0.1)

99.56(-0.2/+0.1)

99.23(-0.3/+0.2)

98.89(-0.4/+0.3)

98.44(-0.7/+0.5)


99.90(-0.1/+0.1)

99.63(-0.2/+0.1)

99.16(-0.3/+0.2)

98.15(-0.4/+0.3)

95.26(-0.6/+0.6)

82.73(-1.2/+1.1)

58.09(-1.8/+1.8)

35.29(-1.9/+2.0)

19.76(-1.8/+2.0)

18.75 @ 109 mo.

(-1.8/+2.0)


Component (Second


99.95(-0.1/+0.0)

99.95(-0.1/+0.0)

99.87(-0.1/+0.1)

99.83(-0.1/+0.1)

99.81(-0.2/+0.1)

99.54(-0.3/+0.2)

98.90(-0.5/+0.3)

98.27(-0.8/+0.6)

98.27(-0.8/+0.6)

98.27 @ 109 mo.

(-0.8/+0.6)


99.97(-0.1/+0.0)

99.73(-0.2/+0.1)

99.18(-0.3/+0.2)

98.00(-0.4/+0.4)

94.67(-0.7/+0.7)

78.35(-1.6/+1.6)

55.70(-2.5/+2.5)

31.53 @ 95 mo.

(-2.9/+3.0)

– –21-Jan-06,18-Jul-05Hermetic Sealing

Component

(Original Pop.)*

MalfunctionsOnly

99.98(-0.1/+0.0)

99.98(-0.1/+0.0)

99.96(-0.1/+0.0)

99.91(-0.1/+0.1)

99.58(-0.3/+0.2)

97.92(-0.7/+0.5)

95.87(-1.2/+1.0)

91.99 @ 95 mo.

(-2.5/+2.0)

– –

*Devices subject to an advisory. Refer to the Advisories for more details. Devices may be part of more than one advisory.Data are representative of Boston Scientific PULSAR MAX and Intermedics VIRTUS Plus device performance.




MERIDIAN DR Model 1276








Registered



99.96(-0.1/+0.0)

99.82(-0.1/+0.1)

99.62(-0.2/+0.1)

98.79(-0.3/+0.2)

97.43(-0.5/+0.4)

94.33(-0.7/+0.6)

85.40(-1.1/+1.1)

67.34(-1.6/+1.6)

47.89(-1.9/+1.9)

38.37(-2.0/+2.0)


MalfunctionsOnly

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

100.00(-0.0/+0.0)

99.98(-0.1/+0.0)

99.98(-0.1/+0.0)

99.98(-0.1/+0.0)

99.98(-0.1/+0.0)

99.98(-0.1/+0.0)

99.98(-0.1/+0.0)


100.00(-0.0/+0.0)

99.58(-0.4/+0.2)

99.22(-0.5/+0.3)

98.25(-0.8/+0.5)

96.18(-1.2/+0.9)

92.36(-1.7/+1.4)

81.65(-2.7/+2.4)

65.42(-3.7/+3.5)

48.56 @ 104 mo.

(-4.2/+4.3)

–21-Jan-06Hermetic Sealing

Component (Second


100.00(-0.0/+0.0)

99.90(-0.3/+0.1)

99.90(-0.3/+0.1)

99.90(-0.3/+0.1)

99.90(-0.3/+0.1)

99.79(-0.5/+0.1)

99.79(-0.5/+0.1)

99.54(-1.0/+0.3)

99.54 @ 104 mo.

(-1.0/+0.3)

–


99.81(-0.2/+0.1)

99.45(-0.3/+0.2)

98.80(-0.4/+0.3)

97.65(-0.6/+0.5)

95.38(-0.9/+0.8)

90.61(-1.4/+1.2)

80.35(-2.3/+2.1)

63.49(-3.3/+3.2)

49.59(-3.8/+3.8)

45.23 @ 111 mo.

(-3.9/+3.9)


Component

(Original Pop.)*

MalfunctionsOnly

99.86(-0.2/+0.1)

99.65(-0.3/+0.2)

99.45(-0.3/+0.2)

99.29(-0.4/+0.2)

99.20(-0.4/+0.3)

99.01(-0.5/+0.3)

98.31(-0.8/+0.6)

97.96(-1.0/+0.7)

97.96(-1.0/+0.7)

97.96 @ 111 mo.

(-1.0/+0.7)


99.13(-1.8/+0.6)

97.80(-2.3/+1.1)

95.86(-3.0/+1.8)

94.12(-3.6/+2.3)

– – – – – –29-Mar-99Integrated Circuit

Chips* MalfunctionsOnly

99.13(-1.8/+0.6)

97.80(-2.3/+1.1)

96.24(-2.9/+1.7)

94.93(-3.4/+2.1)

– – – – – –


Pacing LeadFLEXTEND Active Fixation Models 4086/4087/4088







Registered



218,000 99.60(-0.0/+0.0)

99.39(-0.0/+0.0)

99.18(-0.0/+0.0)

98.91(-0.1/+0.1)

98.62(-0.1/+0.1)

98.26(-0.1/+0.1)

97.88(-0.1/+0.1)

97.51(-0.1/+0.1)

97.12(-0.1/+0.1)

96.87(-0.2/+0.2)

FINELINE II/FINELINE II Sterox Passive Fixation (Polyurethane) Models 4452/4453/4456/4457







Registered



160,000 99.80(-0.0/+0.0)

99.73(-0.0/+0.0)

99.63(-0.0/+0.0)

99.54(-0.0/+0.0)

99.44(-0.0/+0.0)

99.32(-0.1/+0.1)

99.15(-0.1/+0.1)

98.99(-0.1/+0.1)

98.85(-0.1/+0.1)

98.74(-0.1/+0.1)

Data are representative of Boston Scientific FINELINE II (poly) and Intermedics THINLINE II (poly) lead performance.

63 Boston Scientific CRM Product Performance Report published March 20, 2013 BRADYCARDIA THERAPY - PACING LEADS


BRADYCARDIA THERAPY - PACING LEADS

FINELINE II EZ/FINELINE II Sterox EZ Positive Fixation (Polyurethane) Models 4463/4464/4465/4469/4470/4471







Registered



369,000 99.82(-0.0/+0.0)

99.73(-0.0/+0.0)

99.65(-0.0/+0.0)

99.54(-0.0/+0.0)

99.42(-0.0/+0.0)

99.26(-0.0/+0.0)

99.08(-0.1/+0.0)

98.92(-0.1/+0.1)

98.79(-0.1/+0.1)

98.62(-0.1/+0.1)


FINELINE II EZ Positive Fixation (poly) Longitude Models 4463/4464/4465/4469/4470/4471

Leads Enrolled: 414

Leads Active: 347






99.74(-1.5/+0.2)

99.74(-1.5/+0.2)

99.74(-1.5/+0.2)

99.74 @ 41

(-1.6/+0.2)

– – – – – –


327 220 102 52 @ 41 mo

FINELINE II/FINELINE II Sterox Atrial J (Polyurethane) Models 4477/4478/4479/4480







Registered



52,000 99.41(-0.1/+0.1)

99.24(-0.1/+0.1)

99.10(-0.1/+0.1)

98.98(-0.1/+0.1)

98.88(-0.1/+0.1)

98.70(-0.1/+0.1)

98.53(-0.2/+0.1)

98.39(-0.2/+0.2)

98.20(-0.2/+0.2)

98.08(-0.2/+0.2)


FINELINE II/FINELINE II Sterox Passive Fixation (Silicone) Models 4454/4455/4458/4459







Registered



14,000 99.68(-0.1/+0.1)

99.50(-0.1/+0.1)

99.18(-0.2/+0.2)

98.87(-0.2/+0.2)

98.68(-0.3/+0.2)

98.37(-0.3/+0.3)

97.98(-0.4/+0.3)

97.69(-0.4/+0.3)

97.61(-0.4/+0.4)

97.46(-0.5/+0.4)

Data are representative of Boston Scientific FINELINE II (silicone) and Intermedics THINLINE II (silicone) lead performance.

FINELINE II EZ/FINELINE II Sterox EZ Positive Fixation (Silicone) Models 4466/4467/4468/4472/4473/4474







Registered



46,000 99.75(-0.1/+0.0)

99.57(-0.1/+0.1)

99.37(-0.1/+0.1)

99.13(-0.1/+0.1)

98.77(-0.1/+0.1)

98.30(-0.2/+0.2)

97.85(-0.2/+0.2)

97.38(-0.3/+0.2)

97.17(-0.3/+0.3)

96.86(-0.3/+0.3)

Data are representative of Boston Scientific FINELINE II (silicone) and Intermedics THINLINE II (silicone) lead performance.

65 Boston Scientific CRM Product Performance Report published March 20, 2013 BRADYCARDIA THERAPY - PACING LEADS


Malfunction Details: OverviewBoston Scientific CRM pursues product quality and reliability with a passion. We thereforecontinuously monitor product performance to make improvements whenever possible. Thefollowing tables provide a count and description of worldwide malfunctions associated with themajority of actively in-service Boston Scientific products. Intermedics co-branded product data areincluded in corresponding pacemaker and pacing lead malfunction counts and details. Informationpresented is based on malfunctions reported to and analyzed by Boston Scientific. Each tablecontains malfunction counts listed by category, pattern and therapy availability.

CategoryMalfunctions are categorized by the nature of their root cause. For example, a malfunction due to thesoftware within a pulse generator is listed in the Software category. There are four pulse generatormalfunction categories, three malfunction categories for leads reported with previous methodology,and five malfunction categories for leads reported with AdvaMed methodology (described below).

PatternsPatients and physicians have asked for more access to Quality System details; therefore, we provideinformation on patterns of product performance. Patterns listed are informational and do notrepresent actions that need to be taken. Boston Scientific is committed to direct communicationwhen predicted product performance fails to achieve design or performance expectations or whenactions may be taken to improve patient outcomes. Malfunctions associated with product advisoriesare denoted. Refer to the Product Advisories section for more information.

Each pattern description is comprised of the following components:• Clinical Manifestation and Root Cause – Malfunctions for each product are characterized

according to root cause. Descriptions provide clinical observations and/or analysis findingsassociated with each malfunction pattern listed in this report. Malfunctions listed within“Other” either do not yet have an identified root cause, or are related to a proprietary productfeature, such as connectors or seal rings.

• Improvement Implementation – All of the patterns listed are thoroughly investigatedand analyzed. As part of Boston Scientific’s process of continuous improvement, whenpossible, improvements have been or will be implemented in response to identifiedmalfunction patterns. Improvements may include product design changes in existing orsubsequent generations, manufacturing process modifications, software updates, educationalcommunications or labeling changes. Improvement implementation may vary by geographydue to various factors, including regulatory review timing. They may not be applied to everyproduct susceptible to the malfunction pattern, and may not completely mitigate or eliminatethe potential for additional malfunctions.

Pattern information in this report is dynamic. Pattern names, superscript number assignments anddescriptions may all change from quarter to quarter; as Boston Scientific’s investigations progressand improvements are implemented, updated information is provided.

Therapy AvailabilityMalfunctions are further classified according to their impact on therapy, as follows:

• Malfunction With Compromised Therapy – The condition when a device is confirmedthrough laboratory analysis to have malfunctioned in a manner that compromised pacing ordefibrillation therapy (including complete loss or partial degradation) while implanted and inservice. Examples include (but are not limited to): sudden loss of battery voltage; acceleratedcurrent drain such that low battery was not detected before loss of therapy; suddenmalfunction during defibrillation therapy resulting in aborted therapy delivery; intermittentmalfunction in which therapy is compromised while in the malfunction state.

• Malfunction Without Compromised Therapy – The condition when a device is confirmedthrough laboratory analysis to have malfunctioned in a manner that did not compromisepacing or defibrillation therapy while implanted and in service. Malfunctions in which criticalpatient-protective pacing and defibrillation therapies remain available are included here.Examples include (but are not limited to): error affecting diagnostic functions, telemetryfunction, data storage; malfunction of a component that causes the battery to lose powerquickly enough to result in premature battery depletion, but slowly enough that the conditionis detected through normal follow-up before therapy is lost; mechanical problems withconnector header that do not affect therapy.

For lead malfunctions listed in the Extrinsic Factors category, therapy availability may be known,not reported or unable to be determined. When known, these malfunctions are reported in theappropriate therapy availability column. When unknown, because the lead was taken out of serviceand returned, it is assumed that therapy may have been compromised, and will be reported in theWith Compromised Therapy column.

Pulse Generator Confirmed MalfunctionsPulse generator confirmed malfunctions represent devices removed from service and confirmedthrough laboratory analysis to have operated outside the performance limits established by BostonScientific while implanted and in service. Device damage occurring during or after explant, orcaused by external factors including those warned against in product labeling (e.g. therapeuticradiation), are not considered device malfunctions. Damage to a pulse generator caused by a leadmalfunction is reported as a lead malfunction.

Lead MalfunctionsThe Boston Scientific Product Performance Report is in compliance with the May 2009 AdvaMedIndustry Guidance for Uniform Reporting of Clinical Performance of Cardiac Rhythm ManagementPulse Generators and Leads.This methodology also addresses the Recommendations from theHeart Rhythm Society Task Force on Lead Performance Policies and Guidelines. The reportingmethodology outlined in the AdvaMed Guidance has been applied to all lead families currently being

implanted as of May 2009, and will be applied to all future lead families as they are included in thePPR. Lead families which are reported using AdvaMed Guidance methodology include: all CardiacResynchronization Therapy leads, all Reliance leads, all Flextend and Fineline II leads. All other leadswill continue to be reported using previous methodology and categorization.

Malfunction Categories for Currently Implanted LeadsThese malfunction categories include Conductor Fracture, Insulation Breach, Crimps/Welds/Bonds,Other and Extrinsic Factors, and include the following:

• Conductor Fracture: conductor break with complete or intermittent loss of continuity thatcould interrupt current flow (e.g. fractured conductors), including those associated withclavicle flex fatigue or crush damage.

• Insulation Breach: Any lead insulation breach. Examples include: 1) proximal abrasionsassociated with lead-on-lead or lead-on-PG contact in the pocket, 2) mid-lead insulationdamage caused by clavicle flex fatigue or crush, suture or suture sleeve, insulation wearin the region of vein insertion, and 3) distal region wear due to lead-on-lead (intracardiac),lead-on-heart valve or lead-on-other anatomy contact.

• Crimps/Welds/Bonds: Any interruption in the conductor or lead body associated with apoint of connection. Typically demonstrated by high or low shocking/pacing impedance,undersensing or oversensing.

• Other: Includes specific proprietary lead mechanical attributes, such as lead-incorporatedsensors, connectors, seal rings or the 4–Site connector, or malfunction modes not included inthe three categories above.

• Extrinsic Factors: Lead complication where the identified lead was removed from serviceand returned for analysis, where analysis was either inconclusive or the complication wasnot confirmed. Inconclusive includes leads where only portions of the lead were available forreturn, or the returned lead was damaged by the explantation process. Unconfirmed includeswhen lab analysis could not determine an out of specification condition (including complaintsof malfunction or complications such as dislodgements, perforations or failure to capture).

The categories of Conductor, Insulation, Crimps/Welds/Bonds and Other represent malfunctions forleads removed from service and confirmed through laboratory analysis to have operated outsidethe performance limits established by Boston Scientific while implanted and in service. TheExtrinsic Factors category represents malfunctions for leads with reported complications for whichthe leads were removed from service, but for which laboratory analysis was inconclusive or thecomplication was unconfirmed. For the Extrinsic Factors category only, malfunctions are includedfor leads implanted greater than 30 days.


68 Boston Scientific CRM Product Performance Report published March 20, 2013 MALFUNCTION DETAILS: PULSE GENERATORS - CRT-D

CRT-DINCEPTA CRT-D 4-SiteModels N160/N162/P162

Worldwide Distribution: 5,000

Worldwide Confirmed Malfunctions: 1

Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - 1 1

99Transformer - 1

Software - - 0

Other - - 0

Non-patterned - -

WW Confirmed Malfunctions 0 1 1

INCEPTA CRT-DModelsN161/N163/N164/N165/P163/P165Worldwide Distribution: 5,000


Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


ENERGEN CRT-D 4-SiteModels N140/N142/P142



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 1 - 1

117Integrated circuit 1 -

Mechanical - - 0

Software - - 0

Other 1 - 1

Non-patterned 1 -


ENERGEN CRT-DModels N141/N143/P143



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - 2 2

99Transformer - 2

Software - - 0

Other - - 0

Non-patterned - -


PUNCTUA CRT-D 4-SiteModels N050/N052/P052



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


PUNCTUA CRT-DModels N051/N053/P053



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -




COGNISModelsN106/N107/N108/N118/N119/N120/P106/P107/P108Worldwide Distribution: 106,000


Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 74 34 108

106Safety Core-electrocautery 30 15

108High-voltage capacitor 1 2

113Low-voltage capacitors 6 -

117Integrated circuit 5 15

119High voltage circuit - 1

120Battery 7 -

121Low-voltage capacitor 25 1

Mechanical 26 61 87

2Subpectoral implant 2009(Advisory issued)

9 28

99Transformer - 7

104Difficulty securing lead 9 9

111Header contacts 4 6

122Header 4 11

Software 11 - 11

112Safety Core-programming 1 -

115Fault codes not displayedpost-EOL

2 -

118Memory errors 8 -

Other 24 10 34

Non-patterned 24 10


LIVIAN HEModels H227/H229/H247/H249



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 1 1 2


Mechanical - 2 2

104Difficulty securing lead - 2

Software - - 0

Other 1 1 2

Non-patterned 1 -

56Battery depletion - 1


LIVIANModels H220/H225/H240/H245



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - 2 2

40Integrated circuit - 2

Mechanical 1 - 1

45Seal plug 1 -

Software - - 0

Other 2 2 4

Non-patterned - 2

56Battery depletion 2 -


CONTAK RENEWAL 4 RF HEModel H239



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 5 - 5

4Shortened replacementwindow

(Advisory issued)

2 -


105Low-voltage capacitor 1 -

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


CONTAK RENEWAL 4 RFModels H230/H235



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 14 3 17


(Advisory issued)

8 1

18Extended charge timepost mid-life

1 -


66Capacitor 1 -

78Mid-life display ofreplacement indicators

1 -


Mechanical - 2 2

1Magnetic reed switch 2010(Advisory issued)

- 1

29Header - 1

Software - - 0

Other 2 3 5

Non-patterned 1 -

56Battery depletion 1 3


CONTAK RENEWAL 4 HEModels H197/H199



Without

Compromised

Therapy

With

Compromised

Therapy

Total



(Advisory issued)

64 1

6Premature battery depletion(Advisory issued)

2 -


10 -

30Capacitor 1 -


62Capacitor 1 -


24 -

79High-voltage capacitor 1 -


Mechanical 6 4 10


- 1

7Subpectoral implant(Advisory issued)

- 1

29Header 1 1

45Seal plug 2 -

89Setscrew 1 1

91Seal plug 1 -

98Cracked solder joint 1 -

Software - - 0

Other 3 1 4



Non-patterned 1 1



CONTAK RENEWAL 4Models H190/H195



Without

Compromised

Therapy

With

Compromised

Therapy

Total



(Advisory issued)

157 5


14 -


7 -


30Capacitor - 1


62Capacitor - 1

66Capacitor 3 -


63 -



Mechanical 7 14 21


- 3


- 7

12Magnetic switch(Advisory issued)

- 1

29Header 2 -

45Seal plug 3 -

63Circuit connection - 1

89Setscrew - 1

97Reed switch 1 1


Software - - 0

Other 5 6 11

Non-patterned 1 3



CONTAK RENEWAL 4 AVT HEModels M177/M179



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 26 - 26


(Advisory issued)

17 -


3 -


1 -


Mechanical - 1 1


- 1

Software 3 - 3

90Charge time limit 3 -

Other 2 - 2

Non-patterned - -



CONTAK RENEWAL 4 AVTModels M170/M175



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 14 - 14


(Advisory issued)

8 -


1 -

30Capacitor 1 -

66Capacitor 1 -


1 -


Mechanical 2 - 2

45Seal plug 1 -

89Setscrew 1 -

Software - - 0

Other 6 1 7

Non-patterned 2 -



CONTAK RENEWAL 3 RF HEModels H217/H219



Without

Compromised

Therapy

With

Compromised

Therapy

Total



(Advisory issued)

65 5


7 -

30Capacitor 1 -


62Capacitor 1 -


8 -



Mechanical 3 8 11


3 7

89Setscrew - 1

Software - - 0

Other 7 5 12

Non-patterned 4 4








Without

Compromised

Therapy

With

Compromised

Therapy

Total



(Advisory issued)

84 2


1 -

30Capacitor 2 -


62Capacitor 1 -

66Capacitor 3 -


13 -



Mechanical 5 7 12


2 3

45Seal plug 2 -

89Setscrew 1 -

91Seal plug - 1

114Bent flex circuit - 3

Software 3 - 3

22Parameter errors 1 -

77Memory location 1 -

102Misaligned markers 1 -

Other 5 3 8

Non-patterned - 2






Without

Compromised

Therapy

With

Compromised

Therapy

Total



(Advisory issued)

289 12


10 -


97 -

30Capacitor 2 -


62Capacitor 10 4

66Capacitor 7 -


165 -

79High-voltage capacitor - 1


107Resistor - 3

Mechanical 26 11 37


- 2


- 3


2 -

29Header 3 1

45Seal plug 14 3

89Setscrew 7 2

Software 1 - 1


Other 22 6 28

Non-patterned 15 5






Without

Compromised

Therapy

With

Compromised

Therapy

Total



(Advisory issued)

320 13


18 -


46 -


30Capacitor 3 1


62Capacitor 9 3

66Capacitor 12 -

67Device tones 1 -


203 -



Mechanical 37 16 53


- 1


- 5


- 2

29Header 5 2

45Seal plug 26 4

60Adhesive consistency - 1

89Setscrew 4 1

91Seal plug 1 -


Software 3 - 3



Other 29 5 34

Non-patterned 18 4

23Firmware error 1 -





CONTAK RENEWAL 2Model H155



Without

Compromised

Therapy

With

Compromised

Therapy

Total


30Capacitor 3 3


67Device tones 1 -

81Early ERI declaration 654 1

Mechanical 6 38 44

13Shorting under header(Advisory issued)

- 36

31Hybrid circuit - 1

45Seal plug 5 1

89Setscrew 1 -

Software 1 - 1

57Reset during charge 1 -

Other 14 4 18

Non-patterned 7 1



CRT-PINVIVEModelsV172/V173/V182/V183/W172/W173Worldwide Distribution: 3,000


Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


CONTAK RENEWAL TR 2Models H140/H145



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 1 - 1

30Capacitor 1 -

Mechanical 4 - 4

45Seal plug 1 -

68Setscrew block 2 -

91Seal plug 1 -

Software 9 - 9

58Memory error 1 -

76Stored EGMs 8 -

Other 8 1 9

Non-patterned 7 1

87Fault codes 1 -


CONTAK RENEWAL TRModels H120/H125



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 1 1 2

5Low-voltage capacitor(Advisory issued)

1 -

30Capacitor - 1

Mechanical 5 - 5

45Seal plug 5 -

Software 24 - 24

76Stored EGMs 24 -

Other 8 1 9

Non-patterned 7 1

87Fault codes 1 -


77 Boston Scientific CRM Product Performance Report published March 20, 2013 MALFUNCTION DETAILS: PULSE GENERATORS - CRT-P

78 Boston Scientific CRM Product Performance Report published March 20, 2013 MALFUNCTION DETAILS: PULSE GENERATORS - ICD

ICDINCEPTA ICD VR 4-SiteModels E160/F160



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - 1 1

99Transformer - 1

Software - - 0

Other - - 0

Non-patterned - -


INCEPTA ICD DR 4-SiteModels E162/F162



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - 1 1

99Transformer - 1

Software - - 0

Other - - 0

Non-patterned - -


INCEPTA ICD VRModels E161/F161



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - 1 1


Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


INCEPTA ICD DRModels E163/F163



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


ENERGEN ICD VR 4-SiteModels E140/F140



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software 1 - 1


Other - - 0

Non-patterned - -


ENERGEN ICD DR 4-SiteModels E142/F142



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 1 1 2



Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -




ENERGEN ICD VRModels E141/F141



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - 1 1


Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


ENERGEN ICD DRModels E143/F143



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


PUNCTUA ICD VR 4-SiteModels E050/F050



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


PUNCTUA ICD DR 4-SiteModels E052/F052

Worldwide Distribution: 400


Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


PUNCTUA ICD VRModels E051/F051



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


PUNCTUA ICD DRModels E053/F053



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -




TELIGEN VRModels E102/E103/F102/F103



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 47 15 62

106Safety Core-electrocautery - 1




120Battery 20 1


Mechanical 11 45 56


3 8

59Transformer - 1

99Transformer - 10

103Seal plug 1 -



122Header 1 4

Software 9 - 9

3Respiratory SensorOversensing(Advisory issued)

1 -


4 -


Other 6 8 14

Non-patterned 6 8

WW Confirmed Malfunctions 73 68 141 TELIGEN DRModels E110/E111/F110/F111



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 65 17 82

106Safety Core-electrocautery 2 -




120Battery 25 1


Mechanical 12 39 51


2 4

99Transformer - 14

103Seal plug 2 -

104Difficulty securing lead 7 8


122Header - 2

Software 11 - 11


3 -


Other 13 3 16

Non-patterned 13 3


CONFIENT DRModels E030/F030



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 3 - 3

30Capacitor 1 -


Mechanical - - 0

Software - - 0

Other 1 1 2

Non-patterned 1 1


VITALITY 2 EL VRModel T177


Worldwide Confirmed Malfunctions: 1,074

Without

Compromised

Therapy

With

Compromised

Therapy

Total


4Shortened replacementwindow(Advisory issued)

134 1


2 1

18Extended charge timepost-mid-life

5 1


62Capacitor 1 -

66Capacitor 2 -


834 -



Mechanical 1 7 8


- 5

45Seal plug 1 -

99Transformer - 2

Software - 1 1

75Memory location - 1

Other 11 8 19

Non-patterned 11 7



VITALITY 2 EL DRModel T167



Without

Compromised

Therapy

With

Compromised

Therapy

Total



143 2


8 -

30Capacitor 1 -


62Capacitor 1 -


651 -




Mechanical 6 3 9


1 1

45Seal plug 5 1

99Transformer - 1

Software 7 1 8

77Memory location 1 1


Other 3 6 9

Non-patterned 2 3

23Firmware error 1 3




VITALITY 2 VRModel T175



Without

Compromised

Therapy

With

Compromised

Therapy

Total



347 9


- 1


219 6


50 -


30Capacitor 1 -


62Capacitor 1 -

66Capacitor 4 -


750 -



Mechanical 2 1 3

45Seal plug 2 1

Software - 1 1


Other 14 6 20

Non-patterned 12 6


WW Confirmed Malfunctions 1510 34 1544 VITALITY 2 DRModel T165



Without

Compromised

Therapy

With

Compromised

Therapy

Total



477 24


1 -


163 1


88 1


27Reconfirmation after charge 1 -

30Capacitor 1 1


62Capacitor 3 1

66Capacitor 4 -

67Device tones 1 -


264 -



96Logic errors - 3


Mechanical 7 6 13

45Seal plug 4 3

59Transformer - 1

91Seal plug 2 -

123Solder joint 1 2

Software 1 2 3



Other 15 20 35

Non-patterned 9 7



109Magnet rate - 1


VITALITY DR HEModel T180



Without

Compromised

Therapy

With

Compromised

Therapy

Total



85 1


9 -

30Capacitor 2 1


62Capacitor 1 1


147 -



Mechanical 2 13 15


1 9

29Header - 3

89Setscrew 1 -

123Solder joint - 1

Software - 2 2



Other 9 4 13

Non-patterned 8 3



VITALITY DS VRModel T135



Without

Compromised

Therapy

With

Compromised

Therapy

Total



122 1


2 -


61 4


66 -

30Capacitor 2 1


62Capacitor 3 1

66Capacitor 2 1


1203 1



Mechanical 4 2 6

45Seal plug 3 1

91Seal plug - 1


Software 2 - 2

42Impedance measurements 2 -

Other 8 3 11

Non-patterned 6 1




WW Confirmed Malfunctions 1526 17 1543 VITALITY DS DRModel T125



Without

Compromised

Therapy

With

Compromised

Therapy

Total



207 8


68 2


138 2



66Capacitor 3 -


589 -


96Logic errors - 1


Mechanical 11 5 16

45Seal plug 11 3

59Transformer - 1

123Solder joint - 1

Software 6 - 6




Other 16 10 26

Non-patterned 9 3




VITALITY ELModel T127



Without

Compromised

Therapy

With

Compromised

Therapy

Total



30 -


5 -



66Capacitor 1 -


523 1


Mechanical 4 4 8


- 1

29Header - 2

45Seal plug 3 1

89Setscrew 1 -

Software 2 - 2



Other 4 1 5

Non-patterned 2 1

23Firmware error 1 -



VITALITY VRModel 1870



Without

Compromised

Therapy

With

Compromised

Therapy

Total



93 -


30Capacitor 7 -



1012 -

Mechanical 1 2 3

29Header - 1

45Seal plug 1 -

89Setscrew - 1

Software 1 - 1

82Software download 1 -

Other 6 3 9

Non-patterned 4 2



VITALITY DRModel 1871



Without

Compromised

Therapy

With

Compromised

Therapy

Total



157 1

30Capacitor 6 -



534 1


Mechanical 7 2 9

29Header 2 1

45Seal plug 5 -

123Solder joint - 1

Software 3 - 3

57Reset during charge 1 -


Other 3 4 7

Non-patterned 3 3





VITALITY AVT A155Model A155



Without

Compromised

Therapy

With

Compromised

Therapy

Total



13 -


36 1


136 -

30Capacitor 2 3


62Capacitor - 1

66Capacitor 1 -


357 -


Mechanical 15 2 17

45Seal plug 13 -

59Transformer - 2

91Seal plug 2 -

Software 1 26 27

15Functional latching(Advisory issued)

- 26


Other 13 7 20

Non-patterned 9 3


WW Confirmed Malfunctions 585 45 630 VITALITY AVT A135Model A135



Without

Compromised

Therapy

With

Compromised

Therapy

Total



295 4

30Capacitor 3 3



424 -

96Logic errors - 1

Mechanical 1 4 5

45Seal plug - 2

91Seal plug 1 -

123Solder joint - 2

Software - 16 16

15Functional latching(Advisory issued)

- 16

Other 15 5 20

Non-patterned 9 4



VENTAK PRIZM 2 VRModel 1860



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 23 11 34

30Capacitor 15 8



67Device tones 7 -

107Resistor - 1

Mechanical 59 23 82

29Header 17 12

45Seal plug 40 10

89Setscrew 1 -

91Seal plug 1 1

Software 5 1 6




Other 64 26 90

Non-patterned 19 11

35Power on reset 8 -



VENTAK PRIZM 2 DRModel 1861



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 47 15 62

30Capacitor 28 4


54Resistor - 2

67Device tones 11 -


96Logic errors - 1

107Resistor - 2

Mechanical 79 69 148

14Shorting in header(Advisory issued)

- 40

29Header 11 9

32Short circuit - 4

45Seal plug 65 15

63Circuit connection - 1

89Setscrew 1 -

91Seal plug 2 -

Software 24 1 25





100Atrial pacing fault code 4 -


Other 86 43 129

Non-patterned 29 26

35Power on reset 2 -




90 Boston Scientific CRM Product Performance Report published March 20, 2013 MALFUNCTION DETAILS: PULSE GENERATORS - PACEMAKER

PacemakerADVANTIO EL DRModels J064/K064/K067/K084



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


ADVANTIO SRModels J062/J065/K062/K065/K082



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


ADVANTIO DRModels J063/J066/K063/K066/K083



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


INGENIO EL DRModels J174/J177/K174/K177/K184



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


INGENIO SRModels J172/J175/K172/K175/K182



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


INGENIO DRModels J173/J176/K173/K176/K183



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -




ALTRUA 60 SRModel S601



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 1 3 4

30Capacitor 1 1


Mechanical - - 0

Software - - 0

Other - 2 2

Non-patterned - 2


ALTRUA 60 DR ELModel S606



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 3 - 3

30Capacitor 2 -


Mechanical - 1 1


Software - - 0

Other 1 1 2

Non-patterned 1 -



ALTRUA 60 DR (Downsize)Model S603



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 4 4 8

30Capacitor 3 4


Mechanical 2 - 2

101Connector block 1 -

104Difficulty securing lead 1 -

Software - - 0

Other 1 2 3

Non-patterned - 1



ALTRUA 60 DRModel S602



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 1 - 1

30Capacitor 1 -

Mechanical 1 1 2

39Capacitor array 1 -


Software - - 0

Other 1 - 1

Non-patterned 1 -





Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - 1 1

30Capacitor - 1

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


ALTRUA 50 DR (Downsize)Model S502



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 3 - 3

30Capacitor 2 -


Mechanical - 1 1


Software - - 0

Other - - 0

Non-patterned - -




ALTRUA 50 DDD (Downsize)Model S503



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


ALTRUA 50 VDD (Downsize)Model S504



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


ALTRUA 50 SSIModel S508



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -





Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 1 - 1

30Capacitor 1 -

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


ALTRUA 40 DR (downsize)Model S403



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical 2 - 2

103Seal plug 1 -

104Difficulty securing lead 1 -

Software - - 0

Other - - 0

Non-patterned - -





Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 1 - 1

30Capacitor 1 -

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -




ALTRUA 40 DRModel S402



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - 1 1

Non-patterned - -



ALTRUA 20 SRModels S201/S204



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 1 - 1

30Capacitor 1 -

Mechanical - - 0

Software - - 0

Other - 1 1

Non-patterned - 1





Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - 1 1

30Capacitor - 1

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


ALTRUA 20 DR (downsize)Model S203



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 1 - 1

30Capacitor 1 -

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


ALTRUA 20 DRModels S202/S205



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


ALTRUA 20 SSIModel S206



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -




ALTRUA 20 DDDModel S207



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical - - 0

Software - - 0

Other - - 0

Non-patterned - -


INSIGNIA Ultra SRModel 1190



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 2 5 7


1 3

30Capacitor 1 -


Mechanical 3 1 4

45Seal plug 3 -

47Header - 1

Software 1 - 1

58Memory error 1 -

Other 24 - 24

Non-patterned - -

19Longevity labeling 18 -


116Battery status 5 -


INSIGNIA Ultra DR (downsize)Model 1290



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 9 8 17


1 5

30Capacitor 7 3


Mechanical 4 2 6

10Crystal timing componentFailure Mode 2(Advisory issued)

- 1

26Setscrew thread depth 1 -

45Seal plug 2 1

63Circuit connection 1 -

Software 12 - 12

58Memory error 2 -

61Rate fault declaration 1 -

93Underestimation of batterystatus

8 -

95Pacing rate limit 1 -

Other 408 7 415

Non-patterned 19 5





INSIGNIA Ultra DRModel 1291



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 7 5 12


- 2

25Capacitor 1 -

30Capacitor 4 2


Mechanical 7 5 12

45Seal plug 5 4

47Header 1 1

89Setscrew 1 -

Software 3 - 3


2 -


Other 62 4 66

Non-patterned 4 3


48Magnet response 1 -




INSIGNIA Entra SRModels 1195/1198



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 3 4 7


- 2

30Capacitor 2 2


Mechanical 1 6 7


1 -


- 1

39Capacitor array - 2

45Seal plug - 2

91Seal plug - 1

Software - - 0

Other 8 1 9

Non-patterned - 1




INSIGNIA Entra DR (downsize)Model 1296



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 1 4 5


- 1

30Capacitor 1 -


Mechanical - 3 3


- 2

20Solder bond - 1

Software 4 - 4

44Memory error 1 -


1 -

94Interrupted telemetry 2 -

Other 98 2 100

Non-patterned 4 2







INSIGNIA Entra DRModels 1294/1295



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - 3 3


30Capacitor - 1


Mechanical 3 7 10


- 5

45Seal plug 3 -

47Header - 2

Software - - 0

Other 43 1 44

Non-patterned 4 1




INSIGNIA Plus SRModel 1194



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 4 5 9


1 2

30Capacitor 2 2



Mechanical 1 5 6


- 5


Software 1 - 1


Other 16 1 17

Non-patterned 4 -






INSIGNIA Plus DRModel 1297



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 3 3 6


1 1

30Capacitor 2 1


Mechanical 10 7 17


1 2


- 1

20Solder bond 1 -


45Seal plug 5 -

47Header 2 4

Software 6 - 6


3 -



Other 92 2 94

Non-patterned 4 2





INSIGNIA Plus DR (downsize)Model 1298



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 11 10 21


- 3

25Capacitor - 1

30Capacitor 6 2



Mechanical 18 22 40


5 20


3 -

39Capacitor array 3 1

45Seal plug 2 1

47Header 4 -

91Seal plug 1 -

Software 10 - 10

58Memory error 1 -

92Interrogation at EOL 2 -


5 -



Other 345 11 356

Non-patterned 25 9









INSIGNIA AVTModels 0482/0882/0982/1192/1292



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - 5 5


- 3

30Capacitor - 1


Mechanical 1 - 1

45Seal plug 1 -

Software - - 0

Other 43 2 45

Non-patterned 1 1





PULSAR MAX II SR (downsize)Model 1180



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical 1 - 1

72Internal device connection 1 -

Software - - 0

Other 5 - 5

Non-patterned 3 -

21Longevity Remaining error 1 -



PULSAR MAX II DRModel 1280



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 1 - 1

30Capacitor 1 -

Mechanical 9 5 14

11Hermetic sealing componentOriginal Population(Advisory issued)

5 1

33Feedthrough wires 1 4

45Seal plug 1 -


Software 180 - 180

49Overestimation of batterystatus

2 -

58Memory error 1 -

88Diagnostic data error 177 -

Other 29 9 38

Non-patterned 14 8





DISCOVERY II SR (downsize)Model 1184



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - 1 1


Mechanical - 1 1

45Seal plug - 1

Software - - 0

Other 4 1 5

Non-patterned 2 1




DISCOVERY II SRModels 1186/1187



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical 1 - 1


1 -

Software - - 0

Other 1 1 2

Non-patterned 1 -



DISCOVERY II DR (downsize)Model 1283



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - - 0

Mechanical 4 4 8


- 2

33Feedthrough wires - 1

45Seal plug 1 -

51Telemetry or atrial noise 1 1


Software 3 1 4


1 1

58Memory error 1 -

64Memory address 1 -

Other 16 6 22

Non-patterned 3 5



50Impedance - 1





DISCOVERY II DRModels 1284/1286



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical - 1 1


Mechanical 7 4 11


5 2


51Telemetry or atrial noise 1 -

68Setscrew block - 1


Software 3 1 4


- 1

58Memory error 1 -


Other 12 3 15

Non-patterned 3 3




PULSAR MAX DRModel 1270



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 8 4 12

17Integrated circuit chips(Advisory issued)

1 1

30Capacitor 3 -

37High current drain 3 3



8Hermetic sealing componentSecond Population(Advisory issued)

5 6


54 45

33Feedthrough wires 1 4



74Solder bond 1 4

89Setscrew 2 -

Software 111 2 113


2 1

58Memory error 1 1

64Memory address 1 -


88Diagnostic data error 100 -

Other 22 3 25

Non-patterned 14 2




MERIDIAN DRModel 1276



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Electrical 16 18 34

17Integrated circuit chips(Advisory issued)

9 15

37High current drain 5 3



Mechanical 19 13 32

8Hermetic sealing componentSecond Population(Advisory issued)

1 -


14 8

28Pacing wire weld 1 -



55Battery weld - 1

65Telemetry coil 1 1

74Solder bond 1 -

Software - 1 1

58Memory error - 1

Other 4 3 7

Non-patterned 1 2




106 Boston Scientific CRM Product Performance Report published March 20, 2013 REFERENCES

Pattern Descriptions - Pulse GeneratorsEach pattern description below is comprised of the following components: Clinical Manifestationand Root Cause: Malfunctions for each product are characterized according to root cause.Descriptions provide clinical observations and/or analysis findings associated with each malfunctionpattern listed in this report. Pattern descriptions may also include mention of fault codes, which arealerts designed into device diagnostics to provide early warnings for many potential issues, and mayaid in the troubleshooting process and patient management. Improvement Implementation: All ofthe patterns listed are thoroughly investigated and analyzed. As part of Boston Scientific’s processof continuous improvement, when possible, improvements have been or will be implemented inresponse to identified malfunction patterns. These improvements may include product designchanges in existing or subsequent generations, manufacturing process modifications, softwareupdates, educational communications or labeling changes. Improvement implementation mayvary by geography due to various factors, including regulatory review timing. They may not beapplied to every product susceptible to the malfunction pattern, and may not completely mitigate oreliminate the potential for additional malfunctions. Pattern information in this report is dynamic.Pattern names, superscript number assignments and descriptions may all change from quarter toquarter; as Boston Scientific’s investigations progress and improvements are implemented, updatedinformation is provided.

1Magnetic reed switch 2010 – July 21, 2010 Voluntary Physician Advisory. Upon magnet removal,magnetic reed switch remains closed and device tones do not cease. Tachy therapy unavailable ifthe Enable Magnet Use feature is programmed ON.

2Subpectoral implant 2009. December 01, 2009 Voluntary Physician Advisory. Noise, oversensing,inappropriate shocks, pacing inhibition, high impedance when implanted subpectorally. Weakenedbond between header and titanium case. Improvement implemented.

3Respiratory Sensor Oversensing. March 23, 2009 Voluntary Physician Advisory. Oversensing,noise, inappropriate shock, pacing inhibition. When Respiratory Sensor is ON, RV lead or systemcomplications may cause oversensing or noise. Improvement implemented.

4Shortened replacement window – April 05, 2007 and March 04, 2009 Voluntary PhysicianAdvisories. Accelerated battery depletion may reduce time between elective replacement (ERI) andend of life (EOL) indicators to less than three months. Device replacement indicators continue tofunction normally. Degradation of low-voltage capacitor. Improvement implemented.

5Low-voltage capacitor – June 23, 2006 and August 24, 2006 Voluntary Physician Advisories.Premature battery depletion, no output, no interrogation. Failed low-voltage capacitor. Improvementimplemented.

6Premature battery depletion – May 12, 2006 Voluntary Physician Advisory. Premature batterydepletion, significantly shortened longevity and duration between elective replacement (ERI) andend of life (EOL) indicators. Gradual, premature battery depletion most common; in rare instances,

rapid depletion occurred with no therapy available. Failed low-voltage capacitor. Improvementimplemented.

7Subpectoral implant – May 12, 2006 and January 04, 2008 Voluntary Physician Advisories.Beeping tones and programmer warning screen upon interrogation, loss of telemetrycommunications, loss of pacing (intermittent or permanent) and/or loss of shock therapy. Repetitivemechanical stress-induced component damage, only when implanted subpectorally with the serialnumber facing the ribs. Improvement implemented.

8Hermetic sealing component Second Population – January 21, 2006 Voluntary PhysicianAdvisory. Premature battery depletion resulting in loss of telemetry and/or loss of pacing outputwithout warning, appearance of a reset warning message upon interrogation, inappropriate earlydisplay of replacement indicators, inappropriate accelerometer function resulting in sustained pacingat the programmed maximum sensor rate, or lack of appropriate accelerometer rate response duringactivity. Gradual degradation of hermetic sealing component with higher than normal moisturecontent in pacemaker case late in device service life. Improvement implemented.

9Crystal timing component Failure Mode 1 – September 22, 2005 Voluntary Physician Advisory.Intermittent or permanent loss of pacing output without warning, intermittent or permanent loss oftelemetry, reversion to VVI mode or appearance of a reset warning message upon interrogation.Foreign material within a crystal timing component. Improvement implemented.

10Crystal timing component Failure Mode 2 – September 22, 2005 Voluntary Physician Advisory.At implant procedure or during pre-implant testing: Intermittent or permanent loss of pacingoutput without warning, intermittent or permanent loss of telemetry, reversion to VVI mode,or appearance of a reset warning message upon interrogation. Microscopic particle within acrystal timing component. Three failures have been reported following confirmation of successfulimplantation. No currently distributed devices are subject to this peri-implant failure mode.Improvement implemented.

11Hermetic sealing component Original Population – July 18, 2005 and January 21, 2006Voluntary Physician Advisories. Premature battery depletion resulting in loss of telemetry and/orloss of pacing output without warning, appearance of a reset warning message upon interrogation,inappropriate early display of replacement indicators, inappropriate accelerometer function resultingin sustained pacing at the programmed maximum sensor rate or lack of appropriate accelerometerrate response during activity. Gradual degradation of hermetic sealing component with higher thannormal moisture content in pacemaker case late in device service life. Improvement implemented.

12Magnetic switch – June 23, 2005 Voluntary Physician Advisory. Inhibition of tachyarrhythmiatherapy (with no impact on bradycardia pacing) and affecting battery longevity. Magnetic switchstuck in closed position. Improvement implemented.

13Shorting under header – June 17, 2005 Voluntary Physician Advisory. Permanent loss of shockand pacing therapy. Deterioration of wire insulator (in conjunction with other factors), electricshort. Improvement implemented.

14Shorting in header – June 17, 2005 Voluntary Physician Advisory. Permanent loss of shock andpacing therapy. Deterioration of wire insulator (in conjunction with other factors), electrical short.Improvement implemented.

15Functional latching – June 17, 2005 and July 22, 2005 Voluntary Physician Advisories. Limitedtherapy availability. Functional "latching." Original June 17 advisory recommendations revisedbecause new information indicated programming Atrial Tachy Episode Data Storage to 0% causedlatching in subset of devices with previously stored atrial episode data. Reference July 22, 2005advisory for more details. New software is now available worldwide to prevent functional latching.Improvement implemented.

16Safety Mode – April 23, 2001 Voluntary Physician Advisory. Switch to Safety Mode due to rareinteraction between device and specific memory component; beeping tones emitted to alert patient.Affected devices still provide full output shock delivery in Safety Mode. Improvement implemented.

17Integrated circuit chips – March 29, 1999 Voluntary Physician Advisory. Loss of pacing,premature replacement indicators, backup mode operation, disruption of diagnostic measurements.High current drain resulting from a short circuit between two integrated circuit chips. Improvementimplemented.

18Extended charge time post-mid-life. Extended charge time post-mid-life resulting in decreasedlongevity, shortened ERI to EOL or no time stamp, due to increased battery impedance.Improvement implemented.

19Longevity labeling. Battery longevity inconsistent with longevity labeling. Device battery statusindicators are accurate and no loss of therapy has been reported.

20Solder bond. Loss of device output, loss of sensing. Separation of component solder fromsubstrate. Improvement implemented.

21Longevity Remaining error. When near ERT, Longevity Remaining Estimate is incorrect whenamplitude is reprogrammed to a higher value. Gas gauge display is not affected.

22Parameter errors. During RF interrogation, parameter errors occur, requiring manual parametercorrection. Corruption in telemetry logic. Improvement implemented.

23Firmware error. Device beeping unaffected by magnet application, missing EGMs, loss oftelemetry, loss of tachy therapy. Multiple resets due to firmware error. Improvement implemented.

24Integrated circuit. Power on Reset state, loss of telemetry, safety mode operation or loss ofoutput. Failed digital integrated circuit.

25Capacitor. Premature battery depletion, inability to interrogate. Damage to low-voltage capacitor.

26Setscrew thread depth. No pacing or pauses in pacing, intermittent or lack of setscrew contactwith lead. Incorrect setscrew thread depth. Improvement implemented.

27Reconfirmation after charge. Tachy therapy delayed. Redetection and therapy occur after lackof reconfirmation after initial charge. Timing conflict involving specific features. Improvementimplemented.

28Pacing wire weld. Loss of telemetry, loss of pacing. Weld failure between header and internalcircuitry.

29Header. Loosened header at pulse generator replacement or lead revision due to processvariability. Improvement implemented.

30Capacitor. No telemetry, no pacing, premature battery depletion. Gradual, premature batterydepletion most common; in rare instances, rapid depletion occurred with no therapy available.Failed low-voltage capacitor.

31Hybrid circuit. Fault codes or loss of output. Failed solder joints on device hybrid circuit.Improvement implemented.

32Short circuit. Permanent loss of shock and pacing therapy. Deterioration of wire insulator (inconjunction with other factors), electrical short. Improvement implemented.

33Feedthrough wires. High impedance and/or loss of pacing therapy. Broken wire connectingheader to internal circuitry. Improvement implemented.

34Short circuit. Permanent loss of shock and pacing therapy, electrical short. Insulation degradationdue to incorrect wire routing. Improvement implemented.

35Power on reset. Power on Reset state for which tachy and brady therapy are available at presetparameters.

36Battery depletion. Premature battery depletion. Failed battery.

37High current drain. Loss of pacing, premature replacement indicators, backup mode operation,disruption of diagnostic measurements. High current drain resulting from a short circuit betweentwo integrated circuit chips. Improvement implemented.

38Battery depletion. Premature battery depletion.

39Capacitor array. Loss of device output, loss of capture, inability to accurately measure chargetimes causing elective replacement indicator declaration. Damage to capacitor array. Improvementimplemented.



40Integrated circuit. No telemetry, premature battery depletion. Integrated circuit issue withinhigh-voltage transistor.

41Shortened ERI to EOL. Time from ERI to EOL less than expected. Increased battery impedancenear EOL.

42Impedance measurements. High impedance value (generally >3000 ohms) recorded anddisplayed as weekly average impedance. Low daily impedance recordings cause error in calculatingweekly average impedance due to memory storage limitations. Device fully capable of therapydelivery as programmed. Improvement implemented.

43Battery depletion. Premature battery depletion and loss of capture.

44Memory error. Pacing not as expected. Memory map error. Improvement implemented.

45Seal plug. Non-cardiac signals on electrograms leading to inhibition of pacing and/or inappropriateshock delivery. Damaged seal plug. Improvement implemented.

46Oscillator circuit. Beeping and/or display of Fault Code during interrogation shortly after implant.Oscillator circuit operates at higher frequency due to increase in temperature. Improvementimplemented.

47Header. High impedance, compromised header bonding identified during lead revision procedures.Insufficient medical adhesive bonding between header and case. Improvement implemented.

48Magnet response. No magnet response. Particulate material in component. Improvementimplemented.

49Overestimation of battery status. May 06, 2003 Voluntary Physician Advisory. Improvement inbattery status between follow-up visits and/or overestimation of remaining longevity. Very specificconditions involving the use of an atrial tachycardia response feature. Software upgrade distributedlate November 2003 eliminated the possibility of battery status overestimation. Improvementimplemented.

50Impedance. Atrial and/or ventricular pacing impedances >2500 ohms in unipolar and bipolarmodes.

51Telemetry or atrial noise. Noise during telemetry and/or atrial sensing. Inappropriate contactbetween telemetry coil and device case. Improvement implemented.

52Diagnostic data error. No ventricular sense (VS) markers displayed on real-time EGMs whenhysteresis is on. Improvement implemented.

53Integrated circuit. Lack of ventricular markers and reversion to Safety Mode, due to IC fault.Improvement implemented.

54Resistor. Various fault codes upon interrogation. Damaged resistor. Improvement implemented

55Battery weld. No pacing output and/or inability to interrogate. Battery weld. Improvementimplemented.

56Battery depletion. Premature battery depletion.

57Reset during charge. Power on reset state during therapeutic shock charging attempt due tofirmware issue. Improvement implemented.

58Memory error. Device resets (including pacing at reset parameters) and inability to interrogate.Errors in device memory.

59Transformer. Charge time fault code and/or end of life (EOL) indicator displayed, loss of shocktherapy. Damaged transformer. Improvement implemented.

60Adhesive consistency. Non-cardiac signals on electrograms leading to inhibition of pacing and/orinappropriate shock delivery. Bubbles or voids in adhesive. Improvement implemented.

61Rate fault declaration. Inappropriate pacing due to timing interaction when autocapture isprogrammed on. Improvement implemented.

62Capacitor. Premature battery depletion, no telemetry. Damage to capacitor. Improvementimplemented.

63Circuit connection. Loss of telemetry, no magnet tones, loss of pacing, loss of shock therapy.Damaged internal circuit connection. Improvement implemented.

64Memory address. Inability to interrogate. Memory address error. Improvement implemented.

65Telemetry coil. No pacing output and/or an inability to interrogate. Short circuit between pulsegenerator feedthrough wires and telemetry coil. Improvement implemented.

66Capacitor. Premature battery depletion, significantly shortened ERI to EOL time. Gradual,premature battery depletion most common; in rare instances, rapid depletion occurred with notherapy available. Failed low-voltage capacitor. Improvement implemented.

67Device tones. Inappropriately sustained device tone. Magnet removal or initialization ofprogramming event during specific timing window. Device fully capable of therapy delivery asprogrammed. Improvement implemented.

68Setscrew block. No pacing or pauses in pacing, intermittent or lack of setscrew contact withlead. Incorrect setscrew block. Improvement implemented.

69Battery depletion. Premature, gradual depletion of battery; in rare instances, rapid depletion withno therapy available.

70Feedthrough filter capacitor. Inability to interrogate device following shock delivery. High voltagebuild up between feedthrough leads on capacitor surface. Improvement implemented.

71Battery depletion. Loss of therapy, inability to interrogate, no magnet response, prematurebattery depletion.

72Internal device connection. Intermittent or no telemetry. Telemetry coil connection.Improvement implemented.

73Memory location. Inappropriate early display of elective replacement indicator (ERI). Incorrectdata within a specific memory location.

74Solder bond. Inability to interrogate, no magnet response, no pacing output. Broken solder bondbetween wire mounting surface and internal circuitry. Improvement implemented.

75Memory location. Inability to perform diagnostic testing, loss of shock therapy. Incorrect datawithin a specific memory location. Improvement implemented.

76Stored EGMs. Inability to view stored EGMs. Incorrect EGM index location.

77Memory location. Loss of pacing and/or shock therapy, premature battery depletion, inability toperform diagnostic testing, loss of telemetry, and/or incorrect diagnostic information. Incorrect datawithin a specific memory location.

78Mid-life display of replacement indicators. Extended charge time resulting in early occurrenceof ERI or EOL, or shortened ERI to EOL time. Please reference the ERI Charge Time Limit ExtendedDuring Mid-Life Product Update for more details. Improvement implemented.

79High-voltage capacitor. In most cases, temporary long capform charge time; in some casesdelayed therapy or loss of tachy therapy. Extended charge time could prompt EOL declaration.High-voltage capacitor issue.

80Battery post. Inability to interrogate, no pacing output. Bent battery post. Improvementimplemented.

81Early ERI declaration. Early appearance of ERI. Increased battery impedance prompts ERIdeclaration. End of life indicators operate as designed.

82Software download. Safety Mode operation at predetermined brady and tachy parameters.Incomplete software download. Restoration tool available. Improvement implemented.

83A/D module. Inability to obtain telemetry, reversion to Safety Mode, device beeping. Failurewithin Analog to Digital (A/D) module.

84Early ERI declaration. Early appearance of elective replacement indicator (ERI). Increased batteryimpedance extends charge time and prompts ERI declaration. Therapy availability unaffected, end oflife indicators operate as designed. Longevity estimation relabeled. Improvement implemented.

85Integrated circuit. Premature battery depletion, loss of pacing output, inability to interrogate, lossof sensing, high-rate pacing, loss of shock therapy. Damage to integrated circuit. Improvementimplemented.

86Battery depletion. Premature battery depletion due to current drain.

87Fault codes. During programmer interactions, fault codes appear which are able to be cleared. Inone case, a fault code occurred with two memory errors after multiple device resets.

88Diagnostic data error. Potential inability to view daily measurements and/or inappropriateindication of BOL. Rate fault reset. Improvement implemented.

89Setscrew. Inability to tighten or loosen setscrews during implant or replacement procedure dueto process variability. Improvement implemented.

90Charge time limit. Early appearance of elective replacement indicator (ERI). Incorrect extendedcharge time limit. Improvement implemented.

91Seal plug. Lifted or missing seal plugs. Inadequate medical adhesive bond. Improvementimplemented

92Interrogation at EOL. No interrogation at end of life (EOL). Improvement implemented.

93Underestimation of battery status. Underestimation of remaining longevity due to invalid chargetime measurement. Improvement implemented.

94Interrupted telemetry. Early appearance of Elective Replacement Time (ERT) indicator,unexpected impedance measurements (>2500 ohms). Interruption in telemetry sequence duringsoftware upgrade. Improvement implemented.

95Pacing rate limit. Inability to interrogate. Inappropriate pacing due to feature interaction.Improvement implemented.



96Logic errors. Unable to complete diagnostic, cap reform or daily shock lead measurementprocesses; loss of pacing output, loss of shock therapy. Logic errors when device is performingcapacitor reforms or shock impedance measurements.

97Reed switch. While implanted, continuous device tone or beeping occurs. During interrogation,magnet presence dialog box appears. Tachy therapy unavailable if the Enable Magnet Use feature isprogrammed ON. Reed switch stuck in closed position. Improvement implemented.

98Cracked solder joint. Safety mode operation, beeping tones. Cracked solder joint.

99Transformer. Inability to interrogate, loss of pacing and shock therapy. Failed transformer.

100Atrial pacing fault code. Fault code 08 declared, beeping tones due to software design. Noeffect on therapy availability. Improvement implemented.

101Connector block. Connector block can be moved out of alignment or displaced from header.Prolonged implant procedure, high impedance, no pacing, no sensing. Improvement implemented.

102Misaligned markers. Stored episode markers do not match recorded EGM. Software error whenventricular episode begins during ATR episode. New software was released in 2006 which preventsmisaligned markers. Improvement implemented.

103Seal plug. Non-cardiac signals on electrograms may result in loss of pacing or inappropriateshocks. Seal plug allows air in lead port to escape.

104Difficulty securing lead. Noise, high impedance, inappropriate shocks or loss of therapy due tocrossthreaded setscrews, intermittent or lack of contact between lead and header. Improvementimplemented.

105Low-voltage capacitor. Premature battery depletion, early appearance of elective replacementindicator (ERI). Failed low-voltage capacitor. Improvement implemented.

106Safety Core-electrocautery. During electrocautery, device may enter Safety Core. Circuitryresponse to noise caused by electrocautery. Improvement implemented.

107Resistor. Fault code upon interrogation, beeping tones or premature battery depletion. Resistormaterial oxidation. Improvement implemented.

108High-voltage capacitor. Fault code upon interrogation, extended charge time. Damaged highvoltage capacitor.

109Magnet rate. During interrogation, magnet rate remains after removal of magnet. Reed switchstuck in closed position. Improvement implemented.

110Battery status. Battery status readings below BOL at or soon after implant caused by exposureto below room temperatures before implant. Actual battery status and longevity are not affected.Improvement implemented.

111Header contacts. Noise, oversensing, inappropriate shock, high pacing impedance, possible lossof pacing and sensing. Poor header connection with lead terminals due to contacts.

112Safety Core-programming. Device enters Safety Core after three consecutive invalidprogramming attempts, due to firmware issue. Improvement implemented.

113Low-voltage capacitors. Premature battery depletion, fault code during followup, devicebeeping. Capacitor failure.

114Bent flex circuit. Charge time-out and/or EOL declaration, due to bent flex circuit. Improvementimplemented.

115Fault codes not displayed post-EOL. No fault code display after EOL declaration. Improvementimplemented.

116Battery status. Longevity remaining, battery status, gas gauge and/or magnet rate do not align orare inconsistent.

117Integrated circuit. Loss of telemetry, premature battery depletion, fault code during followup.Integrated circuit issue. Improvement implemented.

118Memory errors. Safety mode operation, inaccurately labeled pacing data. Errors in devicememory

119High voltage circuit. Fault code after implant, loss of shock therapy. Failed output module.

120Battery. Beeping tones and fault code upon interrogation. Reduced battery voltage. Improvementimplemented.

121Low-voltage capacitor. Premature battery depletion, fault code during followup, device beeping.Bypass capacitor failure.

122Header. Noise, oversensing, inappropriate shocks, pacing inhibition, high impedance whenimplanted subcutaneously. Weakened bond between header and titanium case. ImprovementImplemented.

123Solder joint. Beeping tones and programmer warning screen upon interrogation, loss oftelemetry communications. Cracked solder joint due to repetitive mechanical stress-inducedcomponent damage when implanted subpectorally with the serial number facing the ribs.

CRT LeadACUITY SpiralModels 4591/4592/4593



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor - 2 2

28Non-patterned, Conductor - 2

Crimp/Weld/Bond - - 0

Extrinsic - 84 84

30Unconfirmed Extrinsic - 84

Insulation - - 0

Other 2 - 2

Non-patterned - -

27Non-patterned, Other 2 -


ACUITY SteerableModels 4554/4555/4556



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor - 30 30


35Extracardiac fracture - 21


Extrinsic 2 171 173


31Inconclusive Extrinsic 2 -

Insulation - - 0

Other 4 2 6

Non-patterned - -

27Non-patterned, Other 4 2


EASYTRAK 3Models4522/4524/4525/4527/4548/4549/4550Worldwide Distribution: 36,000


Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor 2 32 34

28Non-patterned, Conductor 2 4

35Extracardiac fracture - 28


Extrinsic - 77 77


Insulation 1 - 1

29Non-patterned, Insulation 1 -

Other 3 - 3

Non-patterned - -



111 Boston Scientific CRM Product Performance Report published March 20, 2013 MALFUNCTION DETAILS: LEADS - CRT

112 Boston Scientific CRM Product Performance Report published March 20, 2013 MALFUNCTION DETAILS: LEADS - CRT

EASYTRAK 2Models4515/4517/4518/4520/4542/4543/4544Worldwide Distribution: 151,000


Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor 2 328 330

26Conductor fracture 1 284



Extrinsic 4 370 374


31Inconclusive Extrinsic 4 8

Insulation 8 2 10

29Non-patterned, Insulation 8 2

Other 5 5 10

Non-patterned - -



EASYTRAKModels4510/4511/4512/4513/4535/4536/4537/4538Worldwide Distribution: 53,000


Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor - 11 11



Extrinsic - 171 171


31Inconclusive Extrinsic - 1

Insulation 3 3 6


Other 7 1 8

Non-patterned - -



Defibrillation LeadENDOTAK RELIANCE G 4-SiteDual Coil, Active FixationModels 0295/0296



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor - - 0


Extrinsic - 38 38


Insulation 6 - 6


Other 2 - 2



ENDOTAK RELIANCE G 4-SiteDual Coil, Passive FixationModels 0285/0286



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor - - 0


Extrinsic - 2 2


Insulation - - 0

Other - - 0


ENDOTAK RELIANCE SG 4-SiteSingle Coil, Active FixationModels 0292/0293



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor - - 0


Extrinsic - 7 7


Insulation 2 - 2


Other - - 0


113 Boston Scientific CRM Product Performance Report published March 20, 2013 MALFUNCTION DETAILS: LEAD - DEFIBRILLATION


ENDOTAK RELIANCE SG 4-SiteSingle Coil, Passive FixationModels 0282/0283



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor - - 0


Extrinsic 2 1 3



Insulation - - 0

Other - - 0


ENDOTAK RELIANCE GDual Coil, Active FixationModels0164/0165/0166/0167/0184/0185/0186/0187Worldwide Distribution: 244,000


Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor 1 66 67

25Conductor fracture - 40


Crimp/Weld/Bond 2 1 3

32Non-patterned, Crimp, Weld,Bond

2 1

Extrinsic 8 502 510



Insulation 110 16 126


Other 25 11 36



ENDOTAK RELIANCE GDual Coil, Passive FixationModels 0174/0175/0176/0177



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor - 14 14



Crimp/Weld/Bond - 1 1

36Conductor connection - 1

Extrinsic 9 81 90



Insulation 15 2 17


Other 5 - 5



ENDOTAK RELIANCE SGSingle Coil, Active FixationModels 0160/0161/0162/0180/0181/0182



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor 1 28 29




Extrinsic 1 118 119



Insulation 40 5 45


Other 8 4 12



ENDOTAK RELIANCE SGSingle Coil, Passive FixationModels 0170/0171/0172/0173



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor 1 2 3



Extrinsic 3 10 13



Insulation 3 - 3


Other - - 0


ENDOTAK RELIANCEDual Coil, Active FixationModels 0157/0158/0159



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor - 13 13



Crimp/Weld/Bond 3 1 4

3Seal rings 2 1


1 -

Extrinsic 1 174 175



Insulation 30 18 48


Other 9 1 10





ENDOTAK RELIANCEDual Coil, Passive FixationModels 0147/0148/0149



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor - 9 9





Extrinsic 8 111 119



Insulation 20 19 39


Other 2 4 6

4Manufacturing material - 1



ENDOTAK RELIANCE SSingle Coil, Active FixationModels 0137/0138



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor - 1 1



Extrinsic - 8 8


Insulation 5 1 6


Other 1 - 1



ENDOTAK RELIANCE SSingle Coil, Passive FixationModels 0127/0128



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor - - 0


Extrinsic 1 11 12



Insulation 3 1 4


Other 1 1 2



ENDOTAK ENDURANCE EZActive FixationModels 0154/0155/0156



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Lead/Patient Interface 3 3 6

5Lead body 1 2

6Terminal leg insulation 2 1

Mechanical 1 2 3

12Serial number label 1 1


Other 7 9 16

Non-patterned 7 9


ENDOTAK ENDURANCE RxPassive Fixation Steroid ElutingModels 0144/0145/0146



Without

Compromised

Therapy

With

Compromised

Therapy

Total


5Lead body 3 12


Mechanical - 8 8

12Serial number label - 1

18IS-1 terminal pin - 1

22DF-1 terminal pin - 1

23Lead conductor - 5

Other 7 9 16

Non-patterned 7 9


ENDOTAK ENDURANCEPassive FixationModels 0134/0135/0136



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Lead/Patient Interface 1 - 1

6Terminal leg insulation 1 -

Mechanical 1 5 6

18IS-1 terminal pin 1 -

20Yoke component - 3


Other 1 2 3

Non-patterned 1 2




ENDOTAK DSPPassive FixationModels 0094/0095/0125



Without

Compromised

Therapy

With

Compromised

Therapy

Total


5Lead body 14 62



1IS-1 terminal pin(Advisory issued)

21 200

11Lead connector - 1

17Terminal component 3 2


20Yoke component 1 5


Other 10 18 28

Non-patterned 10 18


ENDOTAK PLUSPassive FixationModels 0073/0075/0113/0115



Without

Compromised

Therapy

With

Compromised

Therapy

Total


5Lead body 1 21


Mechanical 1 40 41

8Lead body - 5


12Serial number label 1 -

18IS-1 terminal pin - 25

19Serial number label - 1


Other 2 4 6

Non-patterned 2 4


ENDOTAK 70 SERIESPassive FixationModels 0070/0072/0074



Without

Compromised

Therapy

With

Compromised

Therapy

Total


5Lead body 7 94

6Terminal leg insulation 1 -

16Lead body - 6

Mechanical 3 52 55

8Lead body - 12



11Lead connector 1 2

15Electrode tip 2 4

Other 2 9 11

Non-patterned 2 9


ENDOTAK 60 SERIESPassive FixationModels 0060/0062/0064



Without

Compromised

Therapy

With

Compromised

Therapy

Total


5Lead body 32 97

6Terminal leg insulation - 1

16Lead body 1 11

Mechanical 4 51 55

8Lead body - 16

9Lead conductor - 6


11Lead connector 2 5

15Electrode tip - 3


Other 7 12 19

Non-patterned 7 12



120 Boston Scientific CRM Product Performance Report published March 20, 2013 MALFUNCTION DETAILS: LEAD - PACING

Pacing LeadFLEXTEND 2 Active FixationModels 4095/4096/4097



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor 1 30 31



33Conductor damage 1 14


Extrinsic 1 90 91



Insulation 37 1 38

2Inner insulation abrasion 3 -


34Insulation damage 30 1

Other 11 - 11

Non-patterned 1 -



FLEXTEND Active FixationModels 4086/4087/4088



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor 3 164 167





Extrinsic 2 549 551



Insulation 96 19 115

2Inner insulation abrasion 19 4



Other 14 2 16

Non-patterned - 1



FINELINE II/FINELINE II SteroxPassive Fixation (Polyurethane)Models 4452/4453/4456/4457



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor - 37 37



33Conductor damage - 21


Extrinsic 1 82 83



Insulation 2 7 9


Other 4 - 4

Non-patterned - -



FINELINE II EZ/FINELINE II Sterox EZPositive Fixation (Polyurethane)Models 4463/4464/4465/4469/4470/4471



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor 1 93 94





24Terminal weld - 1


- 1

Extrinsic - 297 297



Insulation 8 6 14


Other 6 1 7

Non-patterned 1 -



FINELINE II/FINELINE IISterox Atrial J (Polyurethane)Models 4477/4478/4479/4480Worldwide Distribution: 222,000


Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor - 8 8

7Lead conductor - 3



Extrinsic - 88 88



Insulation - 1 1

34Insulation damage - 1

Other 32 4 36

Non-patterned - -

21J-shape 30 4



FINELINE II/FINELINE II SteroxPassive Fixation (Silicone)Models 4454/4455/4458/4459



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor - 34 34




Extrinsic - 20 20


Insulation 1 4 5


Other - 3 3

Non-patterned - -

27Non-patterned, Other - 3




FINELINE II EZ/FINELINE II Sterox EZPositive Fixation (Silicone)Models 4466/4467/4468/4472/4473/4474



Without

Compromised

Therapy

With

Compromised

Therapy

Total

Conductor 1 117 118





Extrinsic - 61 61



Insulation 7 8 15



Other 5 2 7

Non-patterned - 1



Pattern Descriptions - LeadsDescriptions listed below provide an overview of the clinical observations and/or analysis findingsassociated with each lead malfunction pattern listed in this report. All of the patterns listedare thoroughly investigated and analyzed. As part of Boston Scientific’s process of continuousimprovement, when possible, improvements have been or will be implemented in responseto identified malfunction patterns. These improvements may include product design changesin existing or subsequent generations, manufacturing process modifications, educationalcommunications or labeling changes. Improvement implementation may vary by geography dueto various factors, including regulatory review timing. They may not be applied to every productsusceptible to the malfunction pattern, and may not completely mitigate or eliminate the potentialfor additional malfunctions.

1IS-1 terminal pin – July 19, 1999 Voluntary Physician Advisory. Compromised insulation and/orconductor integrity if lead is bent sharply away from the header block when placed in implant pocketor if pulse generator migrates from implant site. Improvement implemented.

2Inner insulation abrasion. Loss of capture, decreasing impedance, increased pacing thresholds,noisy signals, oversensing. Abrasion of inner insulation.

3Seal rings. Insertion difficulty at implant, difficulty removing lead from header post-implant.Proximal silicone seal rings not fully adhered to lead terminal. Improvement implemented.

4Manufacturing material. Loss of sensing, loss of pacing, noisy signals. Manufacturing materialembedded in lead body.

5Lead body. Insulation abrasion due to lead-on-lead or lead-on-can contact combined with damageattributed to application of compressive or torsional loads which may be due to clavicle-first ribentrapment. Damage to lead body may expose conductor.

6Terminal leg insulation. Loss of sensing, loss of pacing, loss of defibrillation therapy. Abradedinsulation on terminal leg portion of lead due to lead-on-lead or lead-on-can contact. Improvementimplemented.

7Lead conductor. Loss of capture, inability to deliver therapy. Fatigue of lead conductor due torepeated flexing.

8Lead body. Lead fracture, inappropriate shocks, oversensing. Insulation damage resulting fromimplant stresses or manufacturing variability.

9Lead conductor. Loss of sensing, loss of pacing. Physical damage to lead body due to repeatedflexing.

10Lead conductor. Physical damage to lead conductor, inappropriate shocks, oversensing.Displacement of yoke component may lead to fatigue of high-voltage lead conductor. Improvementimplemented.

11Lead connector. Insulation damage resulting from bending or tension at the terminal connector.May lead to inappropriate shocks, oversensing.

12Serial number label. Loss of sensing, loss of pacing. Sharp edge in serial number label resultingin breach in outer lead insulation. Improvement implemented.

13Conductor connection. Loss of sensing, loss of pacing, loss of defibrillation output. Improperconductor wire connection. Improvement implemented.

14Lead conductor. High impedance, loss of sensing, loss of pacing. Variability in wire conductormaterial. Improvement implemented.

15Electrode tip. Separation between electrode tip and lead body.

16Lead body. Physical damage to lead body, inappropriate shocks. Abraded insulation due tocontact with patient anatomy.

17Terminal component. Loss of sensing, loss of pacing, terminal pin separation from terminal ringduring implant or ICD replacement. Improvement implemented.

18IS-1 terminal pin. Compromised insulation and/or conductor integrity if lead is bent sharply awayfrom the header block when placed in implant pocket or if pulse generator migrates from implantsite. Improvement implemented.

19Serial number label. Loss of sensing, loss of pacing. Broken serial number label due to eithersharp bend away from header at implant or repetitive movement during implant.

20Yoke component. Noise, impedance anomalies, threshold variation. Use of multiple orpre-formed stylets may cause component within lead yoke to dislodge. Improvement implemented.

21J-shape. Placement difficulty, dislodgement. Elevated temperatures resulting in a relaxation ofpre-formed J-shape. Improvement implemented.

22DF-1 terminal pin. Loss of sensing, loss of pacing, loss of defibrillation output. Compromisedinsulation and/or conductor integrity from sharp or excessive bending. Improvement implemented.

23Lead conductor. Muscle stimulation, inappropriate shocks, oversensing, high pacing impedance,inability to deliver therapy. Repeated flexing leading to fatigue of lead conductor.



24Terminal weld. Impedance rise, loss of pacing. Loss of connection on terminal weld.Improvement implemented.

25Conductor fracture. High impedance, loss of capture, loss of pacing, inappropriate shocks. Flexfatigue leading to discontinuity of pace/sense conductor.

26Conductor fracture. High impedance, loss of LV capture, loss of LV pacing. Flex fatigue leading todiscontinuity of conductor.

27Non-patterned, Other. Confirmed malfunction for which the root cause does not fit within othercategories and is not associated with other malfunctions, or has not yet been identified.

28Non-patterned, Conductor. Conductor malfunction (including clavicle fatigue or crush damage)where the root cause is not associated with other malfunctions.

29Non-patterned, Insulation. Lead insulation breach (including damage due to lead-on-lead orlead-on-anatomy contact, clavicle fatigue or crush) where the root cause is not ssociated withother malfunctions.

30Unconfirmed Extrinsic. Lead complication after 30 days of implant time with lead return,where analysis could not identify an out of specification condition. Includes complications such asdislodgement, perforation or failure to capture.

31Inconclusive Extrinsic. Lead complication after 30 days of implant time with lead return, whereanalysis was inconclusive. Includes partial lead returns and leads damaged by the explantationprocess.

32Non-patterned, Crimp, Weld, Bond. Interruption in conductor or lead body associated with apoint of connection where the root cause is not associated with other malfunctions.

33Conductor damage. Noise, oversensing, inappropriate shocks, possible loss of therapy.Conductor damage attributed to application of compressive or torsional loads which may be due toclavicle-first rib entrapment.

34Insulation damage. Low pacing impedance, noise, possible loss of therapy. Insulation abrasiondue to lead-on-lead or lead-on-can contact, or due to application of compressive or torsional loadswhich may be due to clavicle-first rib entrapment. Damage to lead body may expose conductor.

35Extracardiac fracture. High impedance, loss of LV capture, loss of LV pacing. Flex fatigue nearsuture sleeve, not including clavicle-first rib damage, leading to discontinuity of conductor.

36Conductor connection. Loss of sensing, loss of pacing, loss of defibrillation output. Improperconductor wire connection. Improvement implemented.

U.S. Chronic Lead Complications

Boston Scientific strives to provide meaningful detail in describing the performance of our products. Tobe included in the Chronic Lead Complications table, a lead must be successfully implanted, with clinicalobservations occurring after the first month of implant, and have been removed from service surgically orelectronically, but not returned for laboratory analysis. The categories are consistent with the AdvaMed guidancefor Uniform Reporting of Clinical Performance of Cardiac Rhythm Management Pulse Generators and Leads.Although multiple complications are possible for any given lead, only one complication is reported per lead.

The complication reported is determined by a complication hierarchy, indicated by the order of the categories fromleft to right in the table. The number of U.S. Registered Implants is also provided as context for the data. ChronicLead Complications are included in the calculation of survival probability.Complications for both the U.S. Registered Implant population and for leads enrolled in the Longitude SurveillanceRegistry (bottom of table) are provided.

Pacing Leads/Model U.S.Registered Implants

Cardiacperforation

Conductorfracture/helix

damage

Leaddislodgement

Failure tocapture

Oversensing Failure tosense

Insulationbreach

Abnormalpacing

impedance

Abnormaldefibrillationimpedance

Extracardiacstimulation

FLEXTENDActive Fixation4086/4087/4088

218,000 44 508 567 430 113 43 112 233 0 46

FINELINE II/FINELINE II SteroxPassive Fixation (Polyurethane)4452/4453/4456/4457

160,000 0 214 134 117 14 8 125 104 0 17

FINELINE II EZ/FINELINE II Sterox EZPositive Fixation (Polyurethane)4463/4464/4465/4469/4470/4471

369,000 10 311 411 198 18 37 282 198 0 20

FINELINE II/FINELINE IISterox Atrial J (Polyurethane)4477/4478/4479/4480

52,000 0 62 228 78 3 7 39 24 0 5

FINELINE II/FINELINE II SteroxPassive Fixation (Silicone)4454/4455/4458/4459

14,000 1 73 11 30 4 2 12 9 0 1

FINELINE II EZ/FINELINE II Sterox EZPositive Fixation (Silicone)4466/4467/4468/4472/4473/4474

46,000 0 159 47 54 18 6 58 63 0 2

CRT Leads/Model U.S.RegisteredImplants

Cardiacperforation


damage

Leaddislodgement

Failure tocapture


Insulationbreach

Abnormalpacing

impedance



ACUITY Steerable4554/4555/4556

23,000 1 7 194 10 1 0 2 3 0 66

ACUITY Spiral4591/4592/4593

16,000 0 7 95 8 0 0 0 4 0 74



CRT Leads/Model(cont.)

U.S.RegisteredImplants

Cardiacperforation

Conductorfracture/helixdamage

Leaddislodgement

Failure tocapture


Insulationbreach

Abnormalpacing

impedance



EASYTRAK 34522/4524/4525/4527/4548/4549/4550

19,000 1 15 172 23 0 1 4 4 0 68

EASYTRAK 24515/4517/4518/4520/4542/4543/4544

84,000 0 142 711 125 1 1 29 35 0 331

EASYTRAK4510/4511/4512/4513/4535/4536/4537/4538

38,000 1 43 304 72 1 0 30 19 0 231

DefibrillationLeads/Model

U.S.Registered Implants

Cardiacperforation


damage

Leaddislodgement

Failure tocapture


Insulationbreach

Abnormalpacing

impedance



ENDOTAK RELIANCE G 4–SITEDual Coil, Active Fixation0295/0296

13,000 1 1 5 1 1 0 0 0 0 0

ENDOTAK RELIANCE SG 4–SITESingle Coil, Active Fixation0292/0293

6,000 0 0 6 1 0 0 0 0 0 0

ENDOTAK RELIANCE GDual Coil, Active Fixation0164/0165/0166/0167/0184/0185/0186/0187

184,000 9 76 139 38 51 15 27 37 31 14

ENDOTAK RELIANCE GDual Coil, Passive Fixation0174/0175/0176/0177

13,000 0 9 19 7 2 2 4 17 4 1

ENDOTAK RELIANCE SGSingle Coil, Active Fixation0160/0161/0162/0180/0181/0182

22,000 3 9 15 5 10 0 1 6 2 0

ENDOTAK RELIANCEDual Coil, Active Fixation0157/0158/0159

97,000 4 71 50 21 70 10 29 51 16 4

ENDOTAK RELIANCEDual Coil, Passive Fixation0147/0148/0149

33,000 2 40 25 15 21 2 17 58 9 2

DefibrillationLeads/Model (cont)


Cardiacperforation


damage

Leaddislodgement

Failure tocapture


Insulationbreach

Abnormalpacing

impedance



ENDOTAK RELIANCE SSingle Coil, Active Fixation0137/0138

2,000 0 4 0 0 0 0 0 1 0 1

ENDOTAK RELIANCE SSingle Coil, Passive Fixation0127/0128

1,000 0 0 2 1 1 0 0 0 0 0

Longitude SurveillanceRegistry

LeadsEnrolled

Cardiacperforation


damage

Leaddislodgement

Failure tocapture


Insulationbreach

Abnormalpacing

impedance




1054 0 0 7 0 0 0 0 0 0 5


593 0 0 0 0 0 0 0 1 0 0


414 0 0 0 0 0 0 0 0 0 0


128 Boston Scientific CRM Product Performance Report published March 20, 2013 U.S. ACUTE LEAD OBSERVATIONS

U.S. Acute Lead Observations

Boston Scientific strives to provide meaningful product performance information reflective of real-world productexperience. In the first weeks following lead implantation, physiologic responses and lead performance can varyuntil chronic lead stability is attained. Acute lead performance may be subject to a number of factors, includingpatient-specific anatomy, clinical conditions and/or varying implant conditions/techniques.

Because acute implant time contributes to overall clinical experience, Boston Scientific provides specificinformation regarding acute lead performance. To be included in the Acute Lead Observations table, a lead mustfirst be successfully implanted, with clinical observations occurring within the first month of implant.

These reports may or may not have resulted in clinical action and/or product return to Boston Scientific. Thecategories are consistent with the AdvaMed guidance for Uniform Reporting of Clinical Performance of CardiacRhythm Management Pulse Generators and Leads. Although multiple observations are possible for any given lead,only one observation is reported per lead. The observation reported is determined by an observation hierarchy,indicated by the order of the categories from left to right in the table. The number of U.S. Registered Implants isalso provided as context for the data. Acute Lead Observations are not included in calculation of lead survivalprobability.Observations for both the U.S. Registered Implant population and for leads enrolled in the Longitude SurveillanceRegistry (bottom of table) are provided.


Cardiacperforation


damage

Leaddislodgement

Failure tocapture


Insulationbreach

Abnormalpacing

impedance



Pacing Leads/ModelFLEXTEND Active Fixation4086/4087/4088

218,000 214 184 1258 394 61 75 52 198 0 45

FINELINE II/FINELINE II SteroxPassive Fixation (Polyurethane)4452/4453/4456/4457

160,000 14 12 389 151 5 21 21 35 0 18


369,000 63 77 552 205 79 74 52 211 0 33

FINELINE II/FINELINE IISterox Atrial J (Polyurethane)4477/4478/4479/4480

52,000 1 18 402 79 5 26 17 18 0 6

FINELINE II/FINELINE II SteroxPassive Fixation (Silicone)4454/4455/4458/4459

14,000 1 3 34 12 1 2 6 5 0 0

FINELINE II EZ/FINELINE II Sterox EZPositive Fixation (Silicone)4466/4467/4468/4472/4473/4474

46,000 2 15 88 23 8 8 20 12 0 6


Cardiacperforation


damage

Leaddislodgement

Failure tocapture


Insulationbreach

Abnormalpacing

impedance



CRT Leads/ModelACUITY Steerable4554/4555/4556

23,000 0 2 274 35 24 2 6 117 0 207


16,000 5 4 155 49 6 1 8 30 0 170

EASYTRAK 34522/4524/4525/4527/4548/4549/4550

19,000 4 2 237 31 9 1 6 43 0 160

EASYTRAK 24515/4517/4518/4520/4542/4543/4544

84,000 13 6 815 104 44 9 23 181 0 640

EASYTRAK4510/4511/4512/4513/4535/4536/4537/4538

38,000 7 8 195 38 15 1 17 34 0 185


Cardiacperforation


damage

Leaddislodgement

Failure tocapture


Insulationbreach

Abnormalpacing

impedance



DefibrillationLeads/ModelENDOTAK RELIANCE G 4–SITEDual Coil, Active Fixation0295/0296

13,000 7 18 43 21 9 1 4 22 5 2


184,000 116 123 467 124 243 33 46 253 185 60


13,000 4 2 47 26 15 3 0 99 14 0

ENDOTAK RELIANCE SG 4–SITESingle Coil, Active Fixation0292/0293

6,000 2 17 16 5 9 2 2 17 20 3


130 Boston Scientific CRM Product Performance Report published March 20, 2013 U.S. ACUTE LEAD OBSERVATIONS


Cardiacperforation


damage

Leaddislodgement

Failure tocapture


Insulationbreach

Abnormalpacing

impedance



DefibrillationLeads/Model (cont.)ENDOTAK RELIANCE SGSingle Coil, Active Fixation0160/0161/0162/0180/0181/0182

22,000 24 12 62 21 29 12 3 46 108 6


97,000 30 62 160 42 116 20 23 101 43 18


33,000 3 1 60 17 42 5 5 73 2 1


2,000 0 1 1 1 2 1 0 4 7 0


1,000 0 0 1 0 1 1 0 0 0 0

LongitudeSurveillanceRegistry

Leads Enrolled Cardiacperforation


damage

Leaddislodgement

Failure tocapture


Insulationbreach

Abnormalpacing

impedance




1054 0 0 11 9 1 0 0 2 0 33


593 0 0 1 0 1 0 1 0 0 0


414 0 0 1 0 0 0 0 0 0 0

Before/During Implant Procedure –Worldwide Malfunctions: Pulse Generators

This section of the report depicts the number of product malfunctions that occurred worldwideeither before implant (prior to opening the sterile product packaging) or during implant (once thesterile product packaging has been opened). In all cases, the product in question must be returnedto Boston Scientific CRM and confirmed through laboratory analysis to have operated or exhibiteda problem outside the specified performance limits established by Boston Scientific. Damageincurred during shipping/transit or due to external factors warned against in labeling (e.g. radiation)is not reported as device malfunction here.

The majority of before/during implant pulse generator confirmed malfunctions in the Mechanicalcategory are issues occurring within the connector block (e.g. stuck setscrews, seal plug/ringissues). The Electrical category is comprised of confirmed malfunctions involving electricalcomponents such as batteries and capacitors, and also includes fault codes encountered atimplant. The Software category consists primarily of confirmed malfunctions that result intelemetry issues. Confirmed malfunctions in the Labeling and Packaging categories include productlabeling/identification issues and damage to sterile packaging, respectively. The Other category iscomprised of non-patterned confirmed malfunctions.

CRT-D/Model WorldwideDistribution

Electrical Mechanical Software Other Labeling Packaging

INCEPTA CRT-D 4–SITEN160/N162/P162

5,000 0 0 0 0 0 0

INCEPTA CRT-DN161/N163/N164/N165/P163/P165

5,000 0 0 0 0 0 0

ENERGEN CRT-D 4–SITEN140/N142/P142

6,000 1 0 0 1 0 0

ENERGEN CRT-DN141/N143/P143

5,000 1 0 0 3 0 0

PUNCTUA CRT-D 4–SITEN050/N052/P052

1,000 0 0 0 0 0 0

PUNCTUA CRT-DN051/N053/P053

2,000 0 0 0 1 0 0

COGNISN118/N119/N120/P106/P107/P108

106,000 22 50 3 27 0 0

LIVIAN HEH227/H229/H247/H249

7,000 3 1 0 2 0 0

LIVIANH220/H225/H240/H245

6,000 0 1 0 2 0 0


132 Boston Scientific CRM Product Performance Report published March 20, 2013 BEFORE/DURING IMPLANT PROCEDURE

CRT-D/Model (cont.) WorldwideDistribution


CONTAK RENEWAL 4 RF HEH239

1,000 14 0 0 0 0 0

CONTAK RENEWAL 4 RFH230/H235

8,000 45 2 0 1 0 0

CONTAK RENEWAL 4 HEH197/H199

7,000 7 7 0 0 0 0

CONTAK RENEWAL 4H190/H195

18,000 1 13 1 2 0 0

CONTAK RENEWAL 4 AVT HEM177/M179

1,000 0 2 0 1 0 0

CONTAK RENEWAL 4 AVTM170/M175

2,000 1 0 0 1 0 0

CONTAK RENEWAL 3 RF HEH217/H219

18,000 368 4 5 5 0 0


21,000 492 9 1 7 0 0


23,000 60 44 0 9 0 0


34,000 46 65 0 15 0 0

CONTAK RENEWAL 2H155

6,000 1 6 0 5 0 0

CRT-P/Model WorldwideDistribution


INVIVEV172/V173/V182/V183/W172/W173

3,000 0 0 0 1 0 0

CONTAK RENEWAL TR 2H140/H145

30,000 1 8 0 2 0 0

CONTAK RENEWAL TRH120/H125

19,000 0 11 0 5 0 0

ICD/Model WorldwideDistribution


INCEPTA ICD VR 4–SITEE160/F160

4,000 0 0 0 0 0 0

INCEPTA ICD DR 4–SITEE162/F162

5,000 0 0 0 0 0 0

INCEPTA ICD VRE161/F161

2,000 0 0 0 0 0 0

INCEPTA ICD DRE163/F163

2,000 0 0 0 0 0 0

ENERGEN ICD VR 4–SITEE140/F140

6,000 0 0 0 1 0 0

ENERGEN ICD DR 4–SITEE142/F142

6,000 0 0 0 0 0 0

ENERGEN ICD VRE141/F141

3,000 1 0 0 0 0 0

ENERGEN ICD DRE143/F143

4,000 1 0 0 0 0 0

PUNCTUA ICD VR 4–SITEE050/F050

1,000 0 0 0 0 0 0

PUNCTUA ICD DR 4–SITEE052/F052

400 1 0 0 0 0 0

PUNCTUA ICD VRE141/F141

2,000 0 0 0 0 0 0

PUNCTUA ICD DRE053/F053

1,000 1 0 0 0 0 0

TELIGEN VRE102/E103/F102/F103

63,000 6 32 2 18 0 0

TELIGEN DRE110/E111/F110/F111

88,000 6 42 1 23 0 0

CONFIENT DRE030/F030

8,000 1 3 0 0 0 0



ICD/Model (cont.) WorldwideDistribution


VITALITY 2 EL VRT177

16,000 3 5 0 3 0 0

VITALITY 2 EL DRT167

14,000 5 8 0 2 0 0

VITALITY 2 VRT175

37,000 13 13 0 9 0 0

VITALITY 2 DRT165

43,000 16 20 2 25 0 0

Pacemaker/Model WorldwideDistribution


ADVANTIO EL DRJ064/K064/K067/K084

1,000 0 0 0 0 0 0

ADVANTIO SRJ062/J065/K062/K065/K082

3,000 0 0 0 0 0 0

ADVANTIO DRJ063/J066/K063/K066/K083

10,000 1 0 0 1 0 0

INGENIO EL DRJ174J177/K174/K177/K184

4,000 0 0 0 0 0 0

INGENIO SRJ172/J175/K172/K175/K182

4,000 0 0 0 0 0 0

INGENIO DRJ173/J176/K173/K176/K183

14,000 0 0 0 0 0 0

ALTRUA 60 SRS601

63,000 1 6 0 2 0 0

ALTRUA 60 DR ELS606

85,000 0 8 0 2 0 0

ALTRUA 60 DR downsizeS603

126,000 0 22 0 4 0 0

Pacemaker/Model(cont.)

WorldwideDistribution


ALTRUA 60 DRS602

53,000 1 11 0 2 0 0

ALTRUA 50 SRS501

19,000 0 1 0 0 0 0


32,000 0 2 0 1 0 0

ALTRUA 50 DDD downsizeS503

8,000 1 1 0 0 0 0

ALTRUA 50 VDD downsizeS504

5,000 0 0 0 0 0 0

ALTRUA 50 SSIS508

4,000 0 0 0 0 0 0

ALTRUA 40 SRS401

9,000 0 2 0 0 0 0

ALTRUA 40 DR ELS404

9,000 0 0 0 0 0 0


20,000 0 4 0 2 0 0

ALTRUA 40 DRS402

3,000 1 3 0 0 0 0

ALTRUA 20 SRS201/S204

21,000 0 2 0 0 0 0

ALTRUA 20 DR ELS208

9,000 0 0 0 0 0 0


15,000 0 1 0 0 0 0

ALTRUA 20 DRS202/S205

3,000 1 0 0 1 0 0

ALTRUA 20 DDDS207

1,000 0 0 0 0 0 0

ALTRUA 20 SSIS206

6,000 0 0 0 0 0 0



Pacemaker/Model(cont.)



INSIGNIA Ultra SR†

119048,000 3 3 1 4 0 0

INSIGNIA Ultra DR downsize†

1290124,000 3 3 1 6 0 0

INSIGNIA Ultra DR†

129151,000 1 8 1 4 0 0

INSIGNIA Entra SR†

1195/119852,000 1 0 3 5 0 0

INSIGNIA Entra DR downsize†

129647,000 1 7 6 3 0 0

INSIGNIA Entra DR†

1294/129535,000 0 6 4 9 0 0

INSIGNIA Plus SR†

119451,000 1 5 13 5 0 0

INSIGNIA Plus DR downsize†

1298140,000 3 16 30 7 0 1

INSIGNIA Plus DR†

129747,000 0 7 8 7 0 1

INSIGNIA AVT†

0482/0882/0982/1192/129251,000 1 1 0 3 0 0

†Counts consist of Boston Scientific and Intermedics co-branded pacemaker data.

Before/During Implant Procedure –Worldwide Malfunctions: Leads

This section of the report depicts the number of product malfunctions that occurred worldwideeither before implant (prior to opening the sterile product packaging) or during implant (once thesterile product packaging has been opened). In all cases, the product in question must be returnedto Boston Scientific CRM and confirmed through laboratory analysis to have operated or exhibiteda problem outside the specified performance limits established by Boston Scientific. Damageincurred during shipping/transit or due to external factors warned against in labeling is not reportedas device malfunction here.The Conductor category includes any conductor break or damage with complete or intermittent

loss of continuity that could interrupt current flow, including clavicle fatigue or crush damage.The Insulation category includes any lead insulation breach, such as damage due to lead-on-leador lead-on-anatomy contact, or clavicle fatigue or crush. The Crimp/Weld/Bond category includesany interruption in the conductor or lead body associated with a point of connection. The Othercategory includes malfunctions for which the root cause does not fit within other categories or hasnot yet been determined. The Labeling and Packaging categories include product identificationissues and damage to sterile packaging, respectively. The Implant Accessory category includeslead malfunctions due to catheter, guidewire or sheath issues.

CRT Leads/Model WorldwideDistribution

Conductor Insulation Crimp/Weld/Bond Other Labeling Packaging ImplantAccessory


29,000 0 0 0 1 1 0 0

ACUITY Steerable4554/4555/4556

49,000 0 0 0 4 0 2 0

EASYTRAK 34548/4549/4550/4522/4524/4525/4527

36,000 0 2 0 17 0 0 2

EASYTRAK 24542/4543/4544/4515/4517/4518/4520

151,000 0 5 0 7 1 1 1

EASYTRAK4537/4538/4510/4511/4512/4513

53,000 0 0 0 4 0 0 3

DefibrillationLeads/Model



ENDOTAK RELIANCE G 4–SITE,Dual Coil, Active Fixation0295/0296

31,000 0 0 0 20 0 1 0

ENDOTAK RELIANCE G 4–SITE,Dual Coil, Passive Fixation0285/0286

4,000 0 0 0 0 0 1 0

ENDOTAK RELIANCE GDual Coil, Active Fixation0184/0185/0186/0187

244,000 0 0 29 348 0 3 14



DefibrillationLeads/Model (cont.)




38,000 0 0 3 55 0 2 0

ENDOTAK RELIANCE SG 4–SITE,Single Coil, Active Fixation0292/0293

19,000 0 0 0 2 0 1 0

ENDOTAK RELIANCE SGSingle Coil, Active Fixation0180/0181/0182

47,000 0 0 7 53 0 1 3

ENDOTAK RELIANCE SGSingle Coil, Passive Fixation0127/0128

3,000 0 0 0 2 0 0 0


112,000 0 0 17 129 0 0 0


66,000 0 1 1 29 0 1 0


5,000 0 0 1 3 0 0 0


4,000 0 0 0 0 0 0 0

Pacing Leads/Model WorldwideDistribution


FLEXTEND 2Active Fixation4095/4096/4097

127,000 0 0 8 93 1 0 0

FLEXTENDActive Fixation4086/4087/4088

262,000 1 0 54 560 0 1 4

Pacing Leads/Model(cont.)



FINELINE II/FINELINE II SteroxPassive Fixation (polyurethane)†4452/4453/4456/4457

417,000 1 0 2 5 3 23 0

FINELINE II/FINELINE II SteroxEZ Active Fixation (polyurethane)†4463/4464/4465/4469/4470/4471

540,000 2 0 7 53 1 37 2

FINELINE II/FINELINE II SteroxAtrial J (polyurethane)†4477/4478/4479/4480

222,000 0 3 1 128 6 18 0

FINELINE II/FINELINE II SteroxPassive Fixation (silicone)†4454/4455/4458/4459

93,000 0 0 2 1 1 1 0

FINELINE II/FINELINE II SteroxEZ Active Fixation (silicone)†4466/4467/4468/4472/4473/4474

123,000 0 1 1 25 1 6 0

†Counts consist of Boston Scientific and Intermedics co-branded pacing leads data.



U.S. Reason for Out of Service

As requested by the Heart Rhythm Society Task Force on Device Performance Policies andGuidelines, Boston Scientific provides reasons for device explant or out of service, if known. Thereasons consist of normal battery depletion, unconfirmed premature battery depletion, deviceupgrade, device malfunction (which includes devices under advisory that have experienced amalfunction), complication related to another system component or clinical condition (such asinfection), or “other,” a category consisting of patient death, prophylactic device explant, electivereplacement, general product dissatisfaction, other observation/complication, unspecified, orunknown.

The counts for normal battery depletion, unconfirmed premature battery depletion, and devicemalfunction are reflected in the U.S. survival probability data. Reason for device explant or out ofservice may either be confirmed through laboratory analysis (as in the case of device malfunction)or it may be reported to Boston Scientific with no associated device return or laboratory analysis.Although a device may be indicated by the health care provider to have been taken out of servicefor more than one reason, the table below indicates only one reason per device in category counts.

CRT-D/Model U.S.Registered Implants

Normal BatteryDepletion

UnconfirmedPremature

Battery Depletion

Device Upgrade Device Malfunction1 Complication relatedto another system

component or clinicalcondition2

Other3

ENERGEN CRT-D 4–SITEN140/N142/P142

4,000 0 0 1 0 33 117

ENERGEN CRT-DN141/N143/P143

4,000 0 0 0 2 20 137

COGNISN118/N119/N120/P106/P107/P108

74,000 111 15 3 180 1,216 15,271

LIVIAN HEH227/H229/H247/H249

6,000 167 3 1 4 168 1,912

LIVIANH220/H225/H240/H245

5,000 145 0 4 6 113 1,574

CONTAK RENEWAL 3 RF HEH217/H219

18,000 4,306 23 12 136 549 8,413


21,000 3,762 26 12 169 517 9,909


24,000 7,883 91 18 874 604 12,190


34,000 11,380 71 29 973 775 17,919

CRT-P/Model U.S.Registered Implants



Battery Depletion



Other3

CONTAK RENEWAL TRH120/H125

19,000 1,034 10 128 40 225 7,224

ICD/Model U.S.Registered Implants



Battery Depletion



Other3

ENERGEN ICD VR 4–SITEE140/F140

4,000 0 0 0 0 23 73

ENERGEN ICD DR 4–SITEE142/F142

4,000 0 0 2 2 28 84

TELIGEN VRE102/E103/F102/F103

38,000 29 6 280 90 482 5,651

TELIGEN DRE110/E111/F110/F111

66,000 57 4 411 129 848 10,582

CONFIENT DRE030/F030

7,000 19 2 87 5 126 1,915

VITALITY 2 EL VRT177

7,000 422 7 142 767 102 2,149

VITALITY 2 EL DRT167

8,000 780 13 140 659 121 2,646

VITALITY 2 VRT175

21,000 3,073 33 377 1,223 282 8,028

VITALITY 2 DRT165

31,000 6,815 78 520 1,126 431 11,846

VITALITY DR HET180

13,000 806 12 231 362 280 5,466



ICD/Model (cont.) U.S.Registered Implants



Battery Depletion



Other3

VITALITY AVTA155

12,000 4,671 45 139 602 185 5,530

VITALITY AVTA135

7,000 2,386 57 68 661 108 3,460

VITALITY DS DRT125

22,000 6,711 65 359 1,176 292 9,549

VITALITY DS VRT135

19,000 4,432 39 316 1,542 245 8,191

VITALITY ELT127

4,000 629 8 55 592 68 1,419

VENTAK PRIZM 2 DR1861

43,000 11,587 27 413 281 688 27,404

VENTAK PRIZM 2 VR1860

26,000 7,488 13 386 136 369 14,589

VENTAK PRIZM DR HE1853/1858

10,000 3,868 94 51 462 198 4,498

VENTAK PRIZM VR HE1852/1857

9,000 3,525 28 91 359 200 4,320

VENTAK PRIZM DR1851/1856

13,000 5,042 56 54 281 206 6,532

VENTAK PRIZM VR1850/1855

8,000 3,095 14 45 105 111 4,089

Pacemaker/Model U.S.Registered Implants



Battery Depletion



Other3

INGENIO DRJ173/J176/J177/K173/K176/K177/K183/K186/K187

9,000 0 0 4 0 16 68

ALTRUA 60 SRS601

31,000 41 0 149 2 134 7,080

Pacemaker/Model (cont.) U.S.Registered Implants



Battery Depletion



Other3


88,000 217 14 336 12 465 13,902

ALTRUA 60 DRS602

21,000 47 2 113 3 151 3,889

ALTRUA 60 DR ELS606

58,000 28 3 160 6 301 5,299

ALTRUA 40 SRS401

5,000 3 0 14 1 15 1,228


14,000 33 1 28 2 66 2,309

ALTRUA 40 DRS402

2,000 4 0 14 0 6 437

ALTRUA 40 DR ELS404

5,000 0 0 17 0 36 695

ALTRUA 20 SRS201/S204

4,000 9 0 14 0 31 1,333


5,000 16 1 17 0 32 1,108

ALTRUA 20 DRS202/S205

2,000 5 0 5 0 9 463

ALTRUA 20 DR ELS208

3,000 3 0 11 1 7 493

INSIGNIA Ultra SR†

119024,000 591 9 191 25 138 13,685

INSIGNIA Ultra DR downsize†

129076,000 7,390 96 517 352 561 31,993

INSIGNIA Ultra DR†

129132,000 642 14 273 75 276 11,615

INSIGNIA Entra SR†

1195/119814,000 254 10 78 8 71 9,274






Battery Depletion



Other3

INSIGNIA Entra DR downsize†

129624,000 2,908 23 126 94 141 13,614

INSIGNIA Entra DR†

1294/129517,000 494 9 112 47 165 8,862

INSIGNIA Plus SR†

119427,000 1,883 7 221 25 154 18,896

INSIGNIA Plus DR downsize†

129890,000 20,529 113 526 364 689 47,790

INSIGNIA Plus DR†

129727,000 1.678 17 241 108 241 12,655

PULSAR MAX II SR downsize†

11807,000 1,507 8 35 4 30 5,186

PULSAR MAX II DR†

128029,000 8,790 18 175 185 216 16,874

DISCOVERY II SR downsize†

118413,000 1,918 6 36 5 72 10,103

DISCOVERY II SR†

1186/11873,000 260 1 20 2 22 2,518

DISCOVERY II DR downsize†

128333,000 9,655 54 93 29 229 20,567

DISCOVERY II DR†

1284/128623,000 5,523 9 122 20 168 14,609

PULSAR MAX SR downsize†

117011,000 1,907 5 35 8 53 8,043

PULSAR MAX DR†

127041,000 11,336 54 185 220 309 25,799

DISCOVERY SR downsize†

117410,000 1,066 9 34 91 59 8,028




Battery Depletion



Other3

DISCOVERY DR downsize†

127323,000 6,338 72 39 155 136 15,045

DISCOVERY DR†

1274/127513,000 2,557 20 39 142 118 8,964

MERIDIAN SR1176

9,000 1,001 16 20 20 44 7,431

MERIDIAN DR1276

16,000 2,798 17 39 41 122 11,831

1Device malfunction consists of all U.S. confirmed malfunctions for a product/product grouping. These include confirmed malfunctions for advisory populations, as well as any other type of malfunction in which a device was returned and confirmed by laboratory analysis to have malfunctioned. U.S. confirmedmalfunction counts are reflected in U.S. survival probability information.2System component and/or clinical condition complications may include, for example: infection, erosion, lead-to-PG interface.3Other consists of: patient death, elective replacement, general product dissatisfaction, other observation/complication, unspecified, or unknown.†Counts consist of Boston Scientific and Intermedics co-branded pacemaker data.



Product Advisories

A Product Advisory is a voluntary letter issued to inform physicians of an anomalous device behavioridentified by Boston Scientific’s Quality System. A Product Advisory is issued when there is a materialelevation in risk to patient safety with potential for compromised lifesaving therapy, or when BostonScientific can provide meaningful guidance to improve patient outcomes or device performance.Boston Scientific considers many perspectives in the decision to issue a Product Advisory, includinginternal expertise and guidance from an independent Patient Safety Advisory Board (PSAB). The Boardincludes cardiac electrophysiology, engineering, statistics, risk management and bioethics experts.This report section includes summaries of Product Advisories for which significant, active U.S. devicepopulations exist. In general, this includes advisories for which the estimated active U.S. advisory population

is at least 200. Physician and patient letters, as well as Advisory Updates, are available atwww.bostonscientific.com. With respect to the number of reported events listed in the summaries below,Boston Scientific recognizes that the actual number of clinical malfunctions may be greater than the numberactually reported. Additionally, rate projections are provided with the acknowledgment that predictive modelingis inherently uncertain due to its dependence on the device age distribution of reported events and resultantstatistical approximations and assumptions. Advisory notifications may vary by geography, based upon localregulatory requirements. Please contact the local Boston Scientific office for more information. Not allproducts may be approved for use in all geographies, as product approval is geography specific.

PRODUCT ORIGINAL COMMUNICATION July 2010— Magnetic Reed Switch 2010

Voluntary Physician AdvisoryFDA Classification: Class II

Some Boston Scientific defibrillators include a component referred to as a “magnetic reed switch,” designed to sense the presence of a magnet. If Enable MagnetUse is programmed to On (nominally On) and a magnet is applied in emergent situations or during a medical/surgical procedure, the switch is designed to closeand temporarily prevent delivery of undesired tachy therapy. When the magnet is removed, the magnetic switch is designed to open and thereby restoreability to deliver programmed tachy therapy.

Magnetic reed switch technology has historically demonstrated a very low but non-zero rate of failing to open upon magnet removal. However, certain BostonScientific CRT-Ds and ICDs manufactured between January 2006 and November 2007 have exhibited a somewhat higher rate of magnetic reed switch failure.Approximately 34,000 of these devices remain actively implanted; no devices in this population are available for implant. Devices manufactured after November of2007 have returned to historic performance rates and are not included in this advisory.

No patient deaths or injuries have been reported as a result of this issue, although some devices have been replaced. Most devices with a magnetic reed switchconfirmed to be stuck in a closed position have remained implanted after “Enable Magnet Use” was programmed to Off (see Recommendations).

Rate of OccurrenceA rate of one failure per 670 devices (0.0015) has been observed to date in the advisory population (average implant time of 38 months). However, with rapididentification and reprogramming, the probability of patient harm (therapy not available when needed due to a stuck magnetic reed switch) is estimated to be lessthan one in one million for a 60-month device service life.

CURRENT STATUS 16-Jan-13

There have been no reported patient deaths associated with this advisory.

Projected Rate of OccurrenceThe projected rate of occurrence for the advisory device population is 0.0029 at 60 months.

CURRENT RECOMMENDATION 16-Jan-13

A serialized search tool todetermine if a specificdevice is affected by thisproduct advisory is available atwww.bostonscientific.com.





CONTAK RENEWAL 4Models H190/H195/H197/H199

CONTAK RENEWAL4 AVT/AVT HEModelsM170/M175/M177/M179

CONTAK RENEWAL 4 RFModels H230/H235/H239

VITALITY DR HEModel T180 Consistent with physician instructions for use and patient manual labeling, physicians should continue routine follow-up sessions and patients should be reminded to

contact their clinic or go to the hospital emergency room immediately if they hear tones/beeps from their device. In addition, Boston Scientific recommends:

1) In a hospital/clinic/surgery setting, if tones are heard upon magnet application but do not cease upon magnet removal, the device should be interrogated witha programmer and checked per normal standard of care.

Physician and patientletters are available atwww.bostonscientific.com

2) In the United States, use of the LATITUDE remote patient monitoring system may help identify loss of daily measurements and thereby facilitate timely detectionof a stuck reed switch. [NOTE: A pop-up message and/or LATITUDE alert do not appear for missing Daily Measurements.]

3) If a stuck magnetic switch is confirmed, program the Enable Magnet Use feature to Off, which ensures thatprogrammed therapy will be provided to treat tachyarrhythmias. However, if Enable Magnet Use is programmed Off:

– A magnet will no longer inhibit tachy therapy.– The Patient Triggered Monitor feature will no longer be available.

Contact Boston Scientific Technical Services (1-800-CARDIAC) for assistance to re-activate Daily Measurements for devices with a stuck magnetic switch.

4) After consultation with our Independent Patient Safety Advisory Board, Boston Scientific does not recommend prophylactic explant. We further advise thatphysicians do not routinely program Enable Magnet Use to Off in the absence of a confirmed stuck magnetic reed switch because the benefits of magnetuse to disable tachy therapy in emergent situations outweigh the probability of patient harm associated with a stuck reed switch.

Standard Warranty program available; please contact your local representative for terms and conditions.



PRODUCT ORIGINAL COMMUNICATION 01-Dec-09 — Subpectoral Implant 2009


This advisory is limited to devices identified in the product model list that were implanted subpectorally. Devices implanted subcutaneously are not includedin this advisory.

Boston Scientific has determined that the bond between the header and case could be weakened by significant forces associated with a subpectoral implantprocedure or when a device in a subpectoral position is pushed against a rib during contraction of the pectoralis muscle. A weakened header bond may alter leadimpedance and introduce noise that may inhibit pacing therapy or initiate inappropriate tachy therapy. Additional mechanical stress applied to a weakened bond mayeventually cause header connection wires to fracture, resulting in loss of therapy.

A weakened header bond can result in one or more of the following device behaviors:– Significant changes in measured lead impedance– Noise on real-time or stored electrograms– Intermittent inhibition of pacing– Inappropriate anti-tachy pacing or shock therapy– Loss of pacing therapy– Loss of anti-tachy pacing and shock therapy

No patient deaths related to this behavior have been reported. Patients have required early devicereplacement due to inappropriate shocks and/or noise induced by pocket manipulation or arm movement.

Rate of OccurrenceThe implant orientation of devices is not reported to Boston Scientific, making it difficult to provide rate of occurrence and prediction information. Two (2) reportshave been received worldwide of subpectoral implants with weakened header bonds. An estimated 5% of approximately 77,000 COGNIS and TELIGEN devicesworldwide have been implanted in a subpectoral location.

The following factors may also impact the risk of failure if implanted in a subpectoral location:– Exact location of the patient’s ribs relative to the device– Body size and/or muscle mass of the patient (risk may increase for larger/muscular patients)– Activity level and/or occupation of the patient (risk may increase for more active patients)


COGNIS and TELIGEN devices are now available with improved header bond strength in the U.S. and the EU. The stronger bond allows physicians toposition the devices in a subpectoral position, if desired.

Reported events (worldwide)Sixty-seven (67) reports have been received worldwide of subpectoral implants with weakened header bonds. An estimated 10% of approximately 104,000 COGNISand TELIGEN devices worldwide have been implanted in a subpectoral location.

There have been no reported patient deaths associated with this advisory.

Rate of Occurrence

A serialized search tool todetermine if a specificdevice is affected by thissafety advisory is available atwww.bostonscientific.com.

This advisory is limited to thosemodels listed below implantedsubpectorally.

COGNISModelsN106/N107/N108/N118/N119P106/P107/P108

TELIGEN VRModels E102/F102

TELIGEN DRModels E110/E111/F110/F111

Physician and patientletters are availableat www.bostonscientific.com

An estimated 10% of COGNIS and TELIGEN devices worldwide have been implanted in a subpectoral position. The rate of occurrence for subpectoral implants ofCOGNIS advisory devices is 2.5% at 60 months. The rate of occurrence for subpectoral implants of TELIGEN advisory devices is 0.6% at 60 months.


If a patient’s device was implanted subcutaneously, it is excluded from this advisory and no change to current patient management is recommended.

For affected devices implanted in a subpectoral location:– Follow patient at least once every three months as recommended in device instructions for use.– Consider advising patients to contact their physician or clinic if they receive shocks, in order to ensure timely review of associated electrograms and other

device data via in-clinic or remote interrogation.– Where available, consider using the LATITUDE® Patient Management System to facilitate remote device checks between in-clinic follow-ups.

COGNIS and TELIGEN devices are now available with improved header bond strength in the U.S. andthe EU. The stronger bond allows physicians to position the devices in a subpectoral position, if desired.

Standard Warranty program available, please contact your local representative for terms and conditions.



PRODUCT ORIGINAL COMMUNICATION 05-Apr-07 and 04-Mar-09— Shortened Replacement Window


Low-voltage capacitors may be subject to degradation. These capacitors may cause accelerated battery depletion and may reducethe time between Elective Replacement Indicator (ERI) and End Of Life (EOL) to less than three months. Device replacementindicators continue to function normally.

In April 2007, Boston Scientific CRM communicated with physicians regarding a population of devices subject to this failuremechanism. As of March 2009, the April 2007 advisory population has not experienced any clinically significant changes to eitherthe rate of occurrence or patient management recommendations.

In March 2009, a second population was identified of 856 active ICDs and CRT-Ds manufactured with capacitors from the samesupplier that may be subject to the same failure mechanism. The cumulative failure rate for accelerated depletion within thispopulation is approximately 6% at 42 months and is projected to increase. Recommendations described in April 2007 have been99.9% successful in identifying susceptible devices and ensuring replacement at ERI in the original population, and will minimizepatient risk associated with a shortened replacement window when applied to this second population. No devices from thispopulation have been registered as implanted after April 2007. No devices in this subset remain available for implant.


Confirmed Malfunctions (worldwide)April 2007 Population2,547 malfunctions have been confirmed out of an advisory population of approximately 76,000 devices.115 of these devices exhibited a shortened ERI to EOL replacement window (less than 90 days).

March 2009 Population116 malfunctions have been confirmed out of an advisory population of 856 active devices.Two of those devices exhibited a shortened ERI to EOL replacement window (less than 90 days).

There have been no reported patient deaths associated with either advisory population.

No devices currently being distributed are susceptible to this malfunction mode.

Rate of OccurrenceApril 2007 PopulationThe cumulative rate of occurrence for accelerated battery depletion for the April 2007 advisory population is approximately5.0% at 60 months.

March 2009 PopulationThe cumulative rate of occurrence for accelerated battery depletion for the March 2009 advisory population is approximately15.8% at 60 months.

Following monitoring recommendations below will minimize patient risk associated with a shortened replacement window.













CONTAK RENEWAL 3 AVT HEModel M159

CONTAK RENEWAL 3 AVTModel M155

VITALITY 2 EL VR/DRModels T177/T167

VITALITY 2 VR/DRModels T175/T165


VITALITY DS VR/DRModel T135/T125




Patient management recommendations from the April 5, 2007 physician communication remain unchanged.

If a patient has a device with a degraded capacitor, the time from implant to 2.65 volts (Middle of Life 2 / MOL2) will be reduced.To determine whether a patient may be at risk for a reduced ERI to EOL time, note when 2.65 volts (MOL2) was observed. Foreach patient:1. Review patient records to assess battery voltage.2. If battery voltage is above 2.65 volts (MOL2), continue to follow patient every three months per device labeling.3. If battery voltage is at or below 2.65 volts (MOL2), determine the time between device implant and this observation.4. If the time from implant to 2.65 volts (MOL2) is greater than 27 months (32 months for VITALITY® EL / 2 EL / HE devices), thepatient is not at risk for a shortened ERI to EOL time, and this advisory no longer applies.5. If the time from implant to 2.65 volts (MOL2) is 27 months or less (32 months for VITALITY® EL / 2 EL / HE devices), thepatient should be followed monthly until ERI. For devices that require monthly follow-up, replace the device within 30 daysafter ERI is displayed as ERI to EOL time may be shortened.

NOTE: If it is not clear when a battery voltage of less than 2.65 volts (MOL2) was reached, conduct a memory “Save to Disk”and return (mail or e-mail) to Boston Scientific CRM for prompt analysis. Contact your local Boston Scientific representative orTechnical Services for further assistance.

In geographies where available, the LATITUDE® Patient Management System can facilitate remote patient monitoring and provideautomatic notification when the device reaches a battery status of ERI.




PRODUCT ORIGINAL COMMUNICATION 10-Mar-07 — Product Update — Mid-Life Display of Replacement Indicators

FDA Classification: Devices in Table 1, Column 1 of this Product Update were classified as Class II (27-November-07)

Certain devices may display ERI or EOL during mid-life (typically 24–48 months), even though battery voltage (typically greaterthan or equal to 2.65 volts) and capacity remain available. This behavior is caused by high battery impedance rather than lowbattery voltage.

Devices that have triggered charge time-based ERI or EOL during mid-life have several months, and in most cases more than oneyear of remaining battery voltage and capacity, which allows the devices to continue to provide brady and LV pacing and maximumenergy shocks. However, if ERI or EOL is triggered, device replacement should be scheduled.

Rate ProjectionCertain devices, typically implanted prior to July 2005 (Table 1, Column 1 of the Product Update) are projected to exhibit Mid-LifeDisplay of Replacement Indicators as indicated below:– VITALITY AVT (Model A135), VITALITY VR/DR, VITALITY DR+ (Projected rate: 8–10%)– VITALITY AVT (Model A155), VITALITY DS VR/DR, VITALITY 2 VR/DR, ASSURE (Projected rate: 4–7%)– VITALITY EL; VITALITY 2 EL DR/VR; VITALITY DR HE; CONTAK RENEWAL 3/4/3HE/4HE; CONTAK RENEWAL 3 RF/4RF/3RF

HE/4RF HE; CONTAK RENEWAL 3 AVT/4AVT/3AVT HE/4AVT HE (Projected rate: 1–2%)

Continuous manufacturing improvements intended to reduce variability in battery performance have been implemented by ourbattery supplier, which mitigate the occurrence of mid-life display of replacement indicators.

CURRENT STATUS 16-Jan–13

Confirmed Malfunctions (worldwide)For confirmed malfunction counts related to a specific product family, refer to the Confirmed Malfunction Details section of theProduct Performance Report and see pattern titled “Mid-life display of replacement indicators.”There have been no reported patient deaths associated with this advisory.

Projected Rate of OccurrenceFor projected rates of occurrence see device-specific ranges listed above. Some performance differences have been observedbetween product families. For example, dual chamber devices have generally performed better than single chamber devices withinthe same product family. For current performance of a specific product family, refer to the U.S. Survival Probability section of theProduct Performance Report and see population titled “10–Mar-07 Product Update — Mid-Life Display of Replacement Indicators.”


A serialized search tool todetermine if a specificdevice is affected by thisproduct advisory is available atwww.bostonscientific.com


















VITALITY DS VR/DRModels T135/T125


VITALITY VR/DRModels 1871/1870

VITALITY DR+Model 1872

ASSUREModel B301

The Product Update and patientletter are availableat www.bostonscientific.com

Patient management recommendations from the March 10, 2007 Product Update remain unchanged.Patient Management Considerations– Normal follow-up. If ERI or EOL is triggered, device replacement should be scheduled.– Physicians can consider individual patient needs relative to the potential device behaviors associated with mid-life display of

ERI or EOL.– Activating the programmable feature “Beep When ERI is Reached” (nominally ON) will provide audible tones when the device

reaches ERI.– Last measured charge time and date are stored in device memory and are available during device interrogation. Commanding a

manual capacitor reform may be helpful in characterizing the current charge time.


PRODUCT ORIGINAL COMMUNICATION 23-Jun-06 and 24-Aug-06— Low Voltage Capacitor


Devices within a well-defined subset manufactured using low-voltage capacitors from a single component supplier may perform ina manner that leads to device malfunction, including intermittent or permanent loss of output or telemetry, or premature batterydepletion. At the time of the original June 23, 2006 communication, approximately 49,800 devices had been distributed, andapproximately 27,200 devices had been implanted worldwide. Boston Scientific initiated retrieval of all non-implanted deviceswithin this subset from hospital and sales force inventory. An Advisory Update was issued on August 24, 2006, with a revisedestimation of the implanted population to be approximately 31,000. All product currently being shipped and available for implant isnot susceptible to this issue.

Reported Events (worldwide)At the time of the original June 23, 2006 communication, a total of five (5) devices had been confirmed to have malfunctioned. Asreported in the August 24, 2006 Advisory Update, five (5) additional malfunctions were confirmed since the original June 23,2006 communication. A total of 10 confirmed malfunctions represented 0.032% of the implanted population of approximately31,000 devices. Seven (7) of 10 malfunctions were identified while implanted, and three were identified prior to the implantprocedure. There were no reports of patient death associated with this issue. There were a total of three (3) reports of patientsexperiencing syncope associated with loss of pacing.

Projected Rate of OccurrenceWhile a statistically significant projection of expected failures for implanted devices was not possible, testing suggested that thefrequency of new malfunctions would continue to decrease in the future.


Confirmed Malfunctions (worldwide)46 malfunctions have been confirmed from the advisory population. 35 of these were identified while implanted. There were anestimated 32,000 advisory devices implanted. 11 malfunctions were identified prior to implantation.There have been no reported patient deaths associated with this advisory.No devices currently being distributed are susceptible to this malfunction mode.

Projected Rate of OccurrenceThe rate of occurrence is projected to range between 0.10% and 0.22%.


Identifiable by serial number.Not all serial numbers areaffected. A serialized searchtool to determine if a specificdevice is affected by thisproduct advisory is available atwww.bostonscientific.com.

INSIGNIA Ultra SRModels 1190/1390

INSIGNIA Ultra DR(downsize)Models 1290/1490

INSIGNIA Ultra DRModels 1291/1491

INSIGNIA Entra SRModels 1195/1198/1395/1398

INSIGNIA Entra DR(downsize)Models 1296/1466

INSIGNIA Entra DRModels 1294/1295/1494/1495

INSIGNIA Entra SSIModels 0484/0485/1325/1326

INSIGNIA Entra DDDModels 0985/0986/1426

INSIGNIA Plus SRModels 1194/1394

INSIGNIA Plus DR(downsize)Models 1298/1468

INSIGNIA AVTModels 0482/0882/09821192/12921392/1428/1432/1492

CONTAK RENEWAL TR 2Models H140/H145

CONTAK RENEWAL TRModels H120/H125




VITALITY DS VR/DRModels T135/T125


VITALITY VR/DRModels 1870/1871

VENTAK PRIZM 2 VR/DRModels 1860/1861

INSIGNIA Plus DRModels 1297/1467


Patient management recommendations from the August 24, 2006 Advisory Update remain unchanged.

– Normal follow-up.– Physicians should consider the low and declining failure rate in addition to the unique needs of individual patients when

making medical decisions regarding patient management. As always, advise patients to seek attention immediately if theyexperience syncope or lightheadedness.

– Should the device exhibit symptoms described below, please contact your local sales representative or Technical Services forassistance with device evaluation.

Device BehaviorPacemakers: INSIGNIA/NEXUS– Intermittent or permanent loss of pacing output– Inability to interrogate– Erased values in Daily Measurements



– ERT or EOL indicator message displayed earlier than expected– A gas gauge less than BOL within six months of implant

CRT-Ps: RENEWAL TR/TR2– ERI or EOL indicator message displayed earlier than expected– Fault Code 11 message (high current indicator)– A gas gauge less than BOL within six months of implant

ICDs: VENTAK PRIZM 2, VITALITY and VITALITY 2– ERI or EOL indicator message displayed earlier than expected– A battery voltage less than 3.10V within six months of implant


PRODUCT ORIGINAL COMMUNICATION 12-May-06 and 04-Jan-08 Subpectoral Implant


Accelerated life testing has confirmed that repetitive mechanical stress applied to a specific area of the titanium case can induce component damage and devicemalfunction only if the device is implanted subpectorally with the serial number facing the ribs (leads exiting the pulse generator in a clockwise fashion). Ananterior/posterior (AP) radiograph can be used to determine device orientation. Due to component location, damage associated with this failure mode will not occur ina subcutaneous position or in a subpectoral position with the serial number facing up.This failure mechanism can result in one or more of the following device behaviors:– Loss of shock therapy– Loss of pacing therapy (intermittent or permanent)– Loss of telemetry communications– Beeping (16 tones every six hours), and a programmer warning screen upon interrogation

Reported EventsTwo (2) reports of device malfunction associated with subpectoral implantation in an uncommon orientation (serial number facing ribs) were received. No patientdeaths related to this advisory were reported. One patient required external pacing and immediate device replacement due to lack of pacing therapy. The vastmajority of affected devices are implanted subcutaneously and are not subject to this failure mechanism.

Rate of OccurrenceThe implant orientation of devices is not reported. For this reason, no rate of occurrence or failure rate projection was provided. However, based on availableinformation, it is estimated that the number of devices implanted in a susceptible orientation is likely less than 1% of the total population.


Confirmed Malfunctions (worldwide)May 12, 2006 PopulationNineteen (19) malfunctions have been confirmed from an estimated 700 devices implanted in the susceptible orientation.

January 4, 2008 PopulationSeven (7) malfunctions have been confirmed from an estimated 330 devices implanted in the susceptible orientation.

There have been no reported patient deaths associated with either advisory population.

Projected Rate of OccurrenceThe projected rate of occurrence for devices implanted in the susceptible orientation is estimated to be 3% to 4% at 60 months.



This advisory is limited to thosemodels listed below implantedsubpectorally with the serialnumber facing the ribs.






CONTAK RENEWAL 3Models H170/H173/H175






VITALITY DR+Model 1872

Physician and patient

Patient management recommendations for both populations remain unchanged from the May 12, 2006 physician communication.

– For patients implanted with a model listed in the advisory, review records to determine if the device was implanted subpectorally. Devices implantedsubcutaneously are not subject to this advisory.

– For subpectoral implants, use an AP radiograph to determine specific device orientation.• If the leads exit the pulse generator in a counter clockwise direction (serial number facing away from the ribs), this advisory does not apply and no change to

current patient management is necessary.• If the device is in a susceptible orientation (serial number facing the ribs),

– Advise patient of the potential for device failure.– Follow patient at 3 month intervals in accordance with device labeling.– Consider device repositioning or replacement for physically active patients or for patients who regularly need device therapy.



letters are available atwww.bostonscientific.com

– For future implants, when considering subpectoral implantation, orient the device with the serial number facing away from the ribs.


PRODUCT ORIGINAL COMMUNICATION 22-Sep-05 — Crystal Timing Component


Two separate failure modes were identified that may result in intermittent or permanent loss of pacing output without warning,intermittent or permanent loss of telemetry, and/or reversion to VVI mode or appearance of a Reset warning message uponinterrogation. The root cause of the first failure mode is foreign material within a crystal timing component. As of September 22, 2005,the root cause of the second failure mode had not yet been determined and analysis was ongoing. As of the December 12, 2005Advisory Update, root cause had been identified as a microscopic particle within the crystal timing component.

Reported EventsFailure Mode 1—As of September 6, 2005, 36 malfunctions have been confirmed out of 49,500 devices distributed worldwide(0.073%). The majority of malfunctions occurred early in life, with a mean implant time of seven (7) months. There were no reportedpatient deaths. The supplier of the crystal timing component used in this subset of devices has eliminated foreign material within thecrystal chamber, and no malfunctions were observed in any devices shipped after March 12, 2004.

Failure Mode 2—As of September 6, 2005, 16 malfunctions were confirmed out of 341,000 devices distributed worldwide (0.0047%).All 16 devices exhibited a no-output condition at the implant procedure or during pre-implant testing. There were no reported patientdeaths.

Rate ProjectionFailure Mode 1—As of the September 22, 2005 communication, Guidant’s modeling, based on field experience and statistical analysis,predicted the malfunction rate for the active device population of 41,000 to be between 0.017% to 0.037% over the remainingdevice lifetime.


Confirmed Malfunctions (worldwide)Failure Mode 1— 62 malfunctions out of approximately 49,500 advisory population devices have been confirmed. There have been noreported patient deaths associated with this advisory.

Failure Mode 2— 26 malfunctions out of approximately 257,000 (0.010%) devices distributed have been confirmed. Twenty-two (22)malfunctions were identified before or during the implant procedure and four (4) were identified after implant. There have been noreported patient deaths associated with this advisory.

None of the INSIGNIA or NEXUS devices currently being distributed are susceptible to this malfunction mode.

Projected Rate of OccurrenceFailure Mode 1— The rate of occurrence for the estimated worldwide active advisory device population of 9,000 is projected torange between 0.027% and 0.038%.

CURRENT RECOMMENDATION 16-Jan–13


INSIGNIA Ultra SRModels 1190/1390

INSIGNIA Ultra DR (downsize)Models 1290/1490

INSIGNIA Ultra DRModels 1291/1491

INSIGNIA Entra SRModels 1195/1198/1395/1398

INSIGNIA EntraDR (downsize)Models 1296/1466

INSIGNIA Entra DRModels 1294/1295/1494/1495

INSIGNIA Entra SSIModels 0484/0485/1325/1326

INSIGNIA Entra DDDModels 0985/0986/1425/1426

INSIGNIA Plus SRModels 1194/1394

INSIGNIA PlusDR (downsize)Models 1298/1468

INSIGNIA Plus DRModels 1297/1467

INSIGNIA AVTModels0482/0882/0982/1192/12921328/1428/1432/1392/1492


Failure Mode 1—Patient management recommendations from the September 22, 2005 physician communication remain unchanged.Failure Mode 2—Patient management recommendations supersede those originally communicated on September 22, 2005.

– Normal follow-up for both Failure Mode 1 and Failure Mode 2 devices.– Specific to Failure Mode 1, physicians should consider the projected low and declining malfunction rate in addition to the unique

needs of individual patients in their medical decisions regarding patient management. As always, advise patients to seek attentionimmediately if they experience syncope or lightheadedness.




PRODUCT ORIGINAL COMMUNICATION 18-Jul-05 and 21-Jan-06 — Hermetic Sealing Component

Voluntary Physician Advisory (18-Jul-05)FDA Classification: Class I

Voluntary Physician Advisory (21-Jan-06)FDA Classification: Class I

A hermetic sealing component utilized in a subset of pacemakers may experience a gradual degradation, resulting in higher thannormal moisture content within the pacemaker case late in the device’s service life; this could lead to a variety of inappropriateclinical behaviors.

The original July 18, 2005 physician communication bounded the population to approximately 78,000 devices manufacturedbetween November 25, 1997 and October 26, 2000; this number was further refined to 77,500 devices manufactured betweenOctober 27, 1997 and October 26, 2000.

The original July 18, 2005 communication predicted the rate of malfunction in the remaining active implanted devices (estimatedat that time to be 28,000 worldwide) to be between 0.17% and 0.51% over the remaining device lifetime, based on fieldexperience and statistical life-table analysis.

A Second Population of 54,000 devices was subsequently identified to be at risk of hermetic seal degradation (but at a much lowerrate than the original population). This was communicated in the January 21, 2006 letter.

Original Population—Patient management recommendations from the July 18, 2005 physician letter remain unchanged and areprovided below under CURRENT RECOMMENDATION; however, physicians should reassess patients in light of the increasedprojected rate of occurrence (detailed below).

Second Population—Physicians should consider the Original Population recommendations while taking into account the lowerprojected rate of occurrence.

Reported Events (worldwide)Refined Original Population—A total of 145 devices that may have exhibited this malfunction mode were identified; 130 suchmalfunctions were confirmed out of the 77,500 devices manufactured (0.17%).

Second Population—A total of five (5) devices that may have exhibited this malfunction mode were identified; two (2) suchmalfunctions were confirmed out of the 54,000 devices manufactured (0.004%).

Rate ProjectionRefined Original Population—The predicted failure rate for the estimated worldwide active device population of 16,000 hadincreased from the July 18, 2005 estimate as communicated in the January 21, 2006 letter and was projected to range between0.31% and 0.88% over the remaining device lifetime.

Second Population—For the remaining lifetime of the estimated worldwide 19,300 active devices, the projected rate of occurrencefor reported events was estimated to be between 0.02% and 0.06%.


Reported Events (worldwide)Refined Original Population— 340 malfunctions have been confirmed out of the 77,500 advisory population devices.

Second Population— 13 malfunctions have been confirmed out of the 54,000 advisory population devices.


CONTAK TRModel 1241

DISCOVERY II SR (downsize)Models 1184/1384

DISCOVERY II SRModels 1186/1187/1385

DISCOVERY II DR (downsize)Models 1283/1483

DISCOVERY II DRModels 1284/1286/1484/1485

DISCOVERY II SSI (downsize)Models 0481/1349

DISCOVERY II DDDModels 0981/1285/1499

PULSAR MAX II SR (downsize)Models 1180/1380

PULSAR MAX II SRModel 1181

PULSAR MAX II DRModels 1280/1480

DISCOVERY SR (downsize)Model 1174

DISCOVERY SRModel 1175

DISCOVERY DR (downsize)Model 1273

DISCOVERY DRModels 1274/1275

PULSAR MAX SR (downsize)Model 1170

PULSAR MAX SRModel 1171

PULSAR MAX DRModel 1270

PULSARModel 1272/0470/0870/0970/0972/1172

MERIDIAN SSIModel 0476

MERIDIAN DDDModel 0976

MERIDIAN SRModel 1176

MERIDIAN DRModel 1276




Projected Rate of OccurrenceRefined Original Population—The rate of occurrence for the estimated worldwide active device population of 3,000 is projectedto range between 0.31% and 0.88% over the remaining device lifetime, as communicated in the January 21, 2006 AdvisoryUpdate letter.

Second Population—The rate of occurrence for the estimated worldwide active device population of 3,000 is projected to rangebetween 0.02% and 0.06%, as communicated in the January 21, 2006 Advisory Update letter.

CURRENT RECOMMENDATION 16-Jan–13

Original Population—Patient management recommendations from the July 18, 2005 physician letter remain unchanged; however,physicians should reassess patients in light of the increased projected rate of occurrence communicated in the January 21,2006 Advisory Update letter.

Second Population—Physicians should consider the Original Population recommendations while taking into account the lowerprojected rate of occurrence.

– Consider replacing devices for pacemaker-dependent patients.– Advise patients to seek attention immediately if they notice a prolonged rapid heart rate, experience syncope or lightheadedness,

or have new or increased symptoms of heart failure.– Select a suitable Maximum Sensor Rate (MSR) setting, given the rare possibility that inappropriate sustained pacing at MSR

can occur

OR

– Consider programming the accelerometer OFF to prevent inappropriate sustained pacing at MSR.– Consider increasing the frequency of programmer follow-ups. This increases the likelihood of detecting a malfunction that

has already occurred, but does not guarantee that the device will not exhibit this malfunction mode in the future. At eachpatient follow-up:• Evaluate for the clinical behaviors described in the July 18, 2005 letter.• Evaluate battery status for signs of early or rapid depletion between sequential follow-up visits.• Evaluate the accelerometer rate response (for devices with this feature).

– Accelerometer ON:— Look for inappropriate MSR pacing or pacing higher than the programmed lower rate limit (LRL) while the patient is at rest.— Look for lack of rate response with activity (i.e., isometrics, short hall walk).

– Accelerometer OFF:—Temporarily program the accelerometer ON and evaluate as described above

– Consider increasing the frequency of transtelephonic monitoring to detect inappropriate sustained MSR pacing and/or loss ofpacing output.

– If any of these device behaviors are observed, contact your local representative or Technical Services for troubleshooting andrecommendations.


PRODUCT ORIGINAL COMMUNICATION 17-Jun-05 — Shorting Under Header

Voluntary Physician AdvisoryFDA Classification: Class I

CRT-Ds manufactured on or before August 26, 2004 may experience deterioration in a wire insulator surrounding a wire within the lead connector block which, inconjunction with other factors, could cause a short circuit and loss of device function. In all cases, device replacement is required if this short circuit occurs.

Reported EventsFifteen (15) reports were confirmed from approximately 16,000 devices implanted worldwide, including one associated patient death.

Rate ProjectionAs of the June 17, 2005 communication, Guidant predicted that the reported rate of malfunctions may increase to between 0.20% and 0.59% over the devicefamily lifetime, based on field experience and statistical life-table analysis.


Confirmed Malfunctions (worldwide)83 malfunctions have been confirmed out of approximately 16,000 advisory population devices.There have been nine (9) reported patient deaths potentially associated with this advisory.

Projected Rate of Occurrence (worldwide)Approximately 500 advisory population devices remain implanted worldwide. The rate of occurrence is projected to range between 0.72% and 1.83% over theremaining device lifetime.



CONTAK RENEWAL 2Model H155

CONTAK RENEWALModel H135


Patient management recommendations from the June 17, 2005 physician communication remain unchanged.

– Physicians should reassess the balance of relative risks regarding device replacement as a result of the increased projected rate of occurrence as communicated inthe September 12, 2005 Advisory Update.

– Normal follow-up.– Patients should visit their follow-up clinic or doctor as soon as possible after receiving a shock.– Patients should go to their follow-up clinic or hospital emergency room immediately after hearing beeping tones.– If a patient has not recently received a high-voltage therapy, a commanded shock may be performed to confirm integrity of the high-voltage delivery circuit. While

detailed statistical modeling and bench testing indicate that this cannot exclude the low likelihood of subsequent malfunction, a commanded shock may providefurther confidence that high-voltage circuitry is working properly at the time of testing.

– During every patient visit, verify normal device function using routine clinical follow-up procedures.– If a shock has been delivered since the last follow-up:

• Examine the Last Delivered Shock impedance stored in device memory (displayed on the Battery Status screen) for evidence of out-of-range values.• If a yellow warning screen is observed, refer to the Shorted Shock Lead Warning Screen A Closer Look.




PRODUCTORIGINAL COMMUNICATION 17-Jun-05 — Shorting In Header

Voluntary Physician AdvisoryFDA Classification: Class I

ICDs manufactured on or before April 16, 2002 may experience deterioration in a wire insulator within the lead connector block which, in conjunction with otherfactors, could result in an electrical short circuit that can prevent the delivery of shock and pacing therapy.

Reported EventsTwenty-eight (28) malfunctions were reported worldwide from approximately 26,000 devices built prior to the April 2002 manufacturing change, including one eventin which a device was returned after a patient death. No such malfunctions were observed in devices built after the April 2002 manufacturing change. Guidantrecognizes that the actual number of clinical malfunctions may be greater than the number actually reported.


Confirmed Malfunctions (worldwide)40 malfunctions out of approximately 27,000 advisory population devices have been confirmed. There have been five (5) reports of patient death potentiallyassociated with this advisory.Four (4) malfunctions, detected during device interrogation and resulting in no clinical injury, have been identified among the 11,000 devices manufacturedafter April 16, 2002 and before November 13, 2002 (non-advisory population).No malfunctions of this type have been reported to Guidant out of approximately 22,000 devices built after November 13, 2002 (non-advisory population).

Projected Rate of Occurrence (worldwide)– Approximately 1,400 advisory population devices remain implanted worldwide. The rate of occurrence remains unchanged since the September 2005 Advisory

Update communication, and is projected to range between 0.10% and 0.24% over the remaining device lifetime.– Approximately 600 VENTAK PRIZM 2 DR devices manufactured after April 16, 2002 and before November 13, 2002 (non-advisory population) remain implanted

worldwide; engineering analysis and accelerated life testing suggest that the rate of occurrence is between 0.03% and 0.10% by the time all remaining devicescomplete their service life. Rate of occurrence predictions for this group are not statistically conclusive.



VENTAK PRIZM 2 DRModel 1861


Patient management recommendations from the June 17, 2005 physician communication remain unchanged.

– Normal follow-up.– Patients should consult with their follow-up clinic after receiving a shock.– Guidant does not recommend device replacement prior to the appearance of normal elective replacement indicators.– Guidant does not recommend routinely using a commanded shock to detect the shorting problem, since we have insufficient data to indicate that such testing will

be worthwhile for VENTAK PRIZM 2 DR devices. If a patient has not recently received high-voltage therapy, a commanded shock may be performed to confirmintegrity of the high voltage delivery circuit. While detailed statistical modeling and bench testing indicate that this cannot exclude the low likelihood of subsequentmalfunction, a commanded shock may provide further confidence that high voltage circuitry is working properly at the time of testing.


Index

ACUITY Spiral ..................................................................... 18, 111ACUITY Spiral Longitude.............................................................18ACUITY Steerable ............................................................... 18, 111ADVANTIO DR..................................................................... 41, 90ADVANTIO EL DR...................................................................... 90ADVANTIO SR ........................................................................... 90ALTRUA 20 DDD ....................................................................... 97ALTRUA 20 DR .................................................................... 45, 97ALTRUA 20 DR (downsize) .................................................. 44, 96ALTRUA 20 DR EL ............................................................... 44, 96ALTRUA 20 SR..................................................................... 44, 96ALTRUA 20 SSI.......................................................................... 97ALTRUA 40 DR .................................................................... 43, 95ALTRUA 40 DR (downsize) .................................................. 43, 95ALTRUA 40 DR EL ............................................................... 43, 95ALTRUA 40 SR..................................................................... 42, 94ALTRUA 50 DDD (Downsize)..................................................... 93ALTRUA 50 DR (Downsize)........................................................ 93ALTRUA 50 SR........................................................................... 93ALTRUA 50 SSI.......................................................................... 94ALTRUA 50 VDD (Downsize) ..................................................... 94ALTRUA 60 DR .................................................................... 42, 92ALTRUA 60 DR (Downsize).................................................. 42, 92ALTRUA 60 DR EL ............................................................... 41, 92ALTRUA 60 SR..................................................................... 41, 91

Before/During Implant Procedure: Leads .................................137Before/During Implant Procedure: PGs ....................................131

COGNIS ................................................................................11, 69CONFIENT DR..................................................................... 23, 82CONTAK RENEWAL 2 ............................................................... 75CONTAK RENEWAL 3 ..........................................................16, 75CONTAK RENEWAL 3 HE .................................................... 15, 74CONTAK RENEWAL 3 RF.....................................................14, 73CONTAK RENEWAL 3 RF HE...............................................13, 73CONTAK RENEWAL 4 ............................................................... 72CONTAK RENEWAL 4 AVT........................................................ 73

CONTAK RENEWAL 4 AVT HE.................................................. 72CONTAK RENEWAL 4 HE ......................................................... 71CONTAK RENEWAL 4 RF.......................................................... 71CONTAK RENEWAL 4 RF HE.................................................... 70CONTAK RENEWAL TR........................................................17, 77CONTAK RENEWAL TR 2.......................................................... 77

DISCOVERY II DR...............................................................60, 103DISCOVERY II DR (downsize).............................................59, 103DISCOVERY II SR ...............................................................58, 103DISCOVERY II SR (downsize) .............................................57, 102

EASYTRAK.......................................................................... 19, 112EASYTRAK 2....................................................................... 19, 111EASYTRAK 3....................................................................... 19, 111ENDOTAK 60 SERIES Passive Fixation............................... 40, 118ENDOTAK 70 SERIES Passive Fixation............................... 40, 118ENDOTAK DSP Passive Fixation......................................... 39, 117ENDOTAK ENDURANCE EZ Active Fixation....................... 38, 116ENDOTAK ENDURANCE Passive Fixation.......................... 39, 117ENDOTAK ENDURANCE Rx Passive Fixation SteroidEluting............................................................................... 38, 117

ENDOTAK PLUS Passive Fixation....................................... 39, 118ENDOTAK RELIANCE Dual Coil, Active Fixation................. 37, 115ENDOTAK RELIANCE Dual Coil, PassiveFixation ............................................................................. 37, 115

ENDOTAK RELIANCE G 4-Site Dual Coil, ActiveFixation ............................................................................. 35, 113

ENDOTAK RELIANCE G 4-Site Dual Coil, Passive Fixation ............. 113ENDOTAK RELIANCE G Dual Coil, ActiveFixation ............................................................................. 35, 114

ENDOTAK RELIANCE G Dual Coil, Active Fixation Longitude .............36ENDOTAK RELIANCE G Dual Coil, PassiveFixation ............................................................................. 36, 114

ENDOTAK RELIANCE S Single Coil, ActiveFixation ............................................................................. 37, 116

ENDOTAK RELIANCE S Single Coil, PassiveFixation ............................................................................. 38, 116

ENDOTAK RELIANCE SG 4-Site Single Coil, ActiveFixation ............................................................................. 35, 113

ENDOTAK RELIANCE SG 4-Site Single Coil, Passive Fixation ............. 113ENDOTAK RELIANCE SG Single Coil, ActiveFixation ............................................................................. 36, 114

ENDOTAK RELIANCE SG Single Coil, Passive Fixation ............. 115ENERGEN CRT-D ..................................................................10, 68ENERGEN CRT-D 4-Site........................................................10, 68ENERGEN ICD DR............................................................... 22, 80ENERGEN ICD DR 4-Site..................................................... 21, 79ENERGEN ICD VR ..................................................................... 79ENERGEN ICD VR 4-Site ..................................................... 21, 79

FINELINE II EZ Positive Fixation (poly) Longitude...................... 64FINELINE II EZ/FINELINE II Sterox EZ Positive Fixation(Polyurethane) ...................................................................64, 120

FINELINE II EZ/FINELINE II Sterox EZ Positive Fixation(Silicone) ...........................................................................65, 121

FINELINE II/FINELINE II Sterox Atrial J(Polyurethane) ...................................................................64, 121

FINELINE II/FINELINE II Sterox Passive Fixation(Polyurethane) ...................................................................63, 120

FINELINE II/FINELINE II Sterox Passive Fixation(Silicone) ...........................................................................65, 121

FLEXTEND 2 Active Fixation ....................................................120FLEXTEND Active Fixation .................................................63, 120

INCEPTA CRT-D ..................................................................... 9, 68INCEPTA CRT-D 4-Site ........................................................... 9, 68INCEPTA ICD DR....................................................................... 78INCEPTA ICD DR 4-Site....................................................... 20, 78INCEPTA ICD VR ....................................................................... 78INCEPTA ICD VR 4-Site ....................................................... 20, 78Index.........................................................................................167INGENIO DR........................................................................ 41, 91INGENIO EL DR......................................................................... 90INGENIO SR .............................................................................. 91INSIGNIA AVT........................................................................... 101



INSIGNIA Entra DR.............................................................. 51, 99INSIGNIA Entra DR (downsize)............................................ 50, 99INSIGNIA Entra SR .............................................................. 49, 99INSIGNIA Plus DR ..............................................................54, 100INSIGNIA Plus DR (downsize) ............................................ 53, 101INSIGNIA Plus SR...............................................................52, 100INSIGNIA Ultra DR............................................................... 48, 98INSIGNIA Ultra DR (downsize) ............................................ 47, 98INSIGNIA Ultra SR............................................................... 46, 98INVIVE ....................................................................................... 77

LIVIAN ..................................................................................12, 70LIVIAN HE.............................................................................11, 70

Malfunction Details: LeadCRT ....................................................................................... 111Defibrillation .......................................................................... 113Pacing ...................................................................................120

Malfunction Details: OverviewOverview................................................................................ 66

Malfunction Details: Pulse Generators— CRT-P................................................................................. 77Pacemaker ............................................................................. 90

Malfunction Details: Pulse Generators —CRT-D ..................................................................................... 68ICD......................................................................................... 78

MERIDIAN DR....................................................................62, 104

Product Advisories....................................................................146PULSAR MAX DR...............................................................61, 104PULSAR MAX II DR............................................................56, 102PULSAR MAX II SR (downsize) ..........................................55, 102PUNCTUA CRT-D ....................................................................... 69PUNCTUA CRT-D 4-Site............................................................. 69PUNCTUA ICD DR..................................................................... 81PUNCTUA ICD DR 4-Site........................................................... 80PUNCTUA ICD VR ..................................................................... 81PUNCTUA ICD VR 4-Site ........................................................... 80

Statistical Methodology............................................................... 2Supporting Greater Return of Explanted Devices........................ 7

TELIGEN DR........................................................................ 23, 82TELIGEN VR ........................................................................ 22, 81

U.S. Acute Lead Observations..................................................128U.S. Chronic Lead Complications .............................................125U.S. Reason for Out of Service ................................................140

VENTAK PRIZM 2 DR .......................................................... 34, 89VENTAK PRIZM 2 VR........................................................... 34, 88VITALITY 2 DR ..................................................................... 27, 84VITALITY 2 EL DR................................................................ 25, 83VITALITY 2 EL VR ................................................................ 24, 83VITALITY 2 VR...................................................................... 26, 83VITALITY AVT A135 ............................................................. 30, 88VITALITY AVT A155 ............................................................. 29, 87VITALITY DR .............................................................................. 87VITALITY DR HE .................................................................. 28, 85VITALITY DS DR .................................................................. 32, 86VITALITY DS VR................................................................... 31, 85VITALITY EL......................................................................... 33, 86VITALITY VR............................................................................... 87

Contact InformationArgentinaBoston Scientific Argentina S.A.Av. Cabildo 2677 — Piso 6C1428AAI Buenos AiresArgentinaTel: 54 11 4896 8500Fax: 54 11 4896 8550

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Patients and Families:1.866.484.3268


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