November Edition of Sorin Group CRM’s 2007 Product … · 2018-06-21 · sorin group crm 2 contents 1 sorin group commitment to quality 4 2 definitions and methods 5 3 cardiac resynchronization

Cardiac Rhythm Management

2007November

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Product Performance Report

Sorin Group CRM 2

Contents

1 SORIN GROUP COMMITMENT TO QUALITY 4

2 DEFINITIONS AND METHODS 5

3 CARDIAC RESYNCHRONIZATION THERAPY (CRT) 8

3.1 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) 8 3.1.1 Ovatio CRT 6750 8 3.1.2 Alto MSP 627 - 617 8

3.2 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (CRT-P) 9 3.2.1 Talent 3 MSP 353 - MSP AF 343 - MSP 313 9

3.3 CARDIAC RESYNCHRONIZATION THERAPY LEADS 10 3.3.1 Situs OTW UW28D 10 3.3.2 Situs LV UC28D - UL28D 10

4 TACHYCARDIA THERAPY 11

4.1 CARDIOVERTER DEFIBRILLATORS (ICDS) 11 4.1.1 Ovatio DR 6550 - VR 6250 11 4.1.2 Alto 2 DR 624 - VR 625 12 4.1.3 Alto DR 614 - VR 615 12

4.2 DEFIBRILLATION LEADS 13 4.2.1 Isoline 2CR6 - 2CT6 13 4.2.2 Swift 4041 13

5 BRADYCARDIA THERAPY 14

5.1 PACEMAKERS 14 5.1.1 Symphony DR 2550 - SOLE DR 14 5.1.2 Symphony D 2450 - VDR 2350 - SOLE VDR 15 5.1.3 Symphony SR 2250 - SOLE SR 15 5.1.4 Rhapsody DR 2510 - SR 2210 - + DR 2530 16 5.1.5 Rhapsody D 2410 - S 2130 16 5.1.6 Talent 3 DR 253 - VDR 263 17 5.1.7 Talent II DR 233 17 5.1.8 Talent II SR 133 18 5.1.9 Talent DR 213 18 5.1.10 Talent AF 243 19 5.1.11 Talent D 210 19 5.1.12 Talent SR 113 20 5.1.13 Brio DR 212 - DR 222 20 5.1.14 Brio D 220 21 5.1.15 Brio SR 112 21 5.1.16 Elect D - DR - SR - VDR 22 5.1.17 Diapason - Elect XS 22 5.1.18 Neway - NewLiving 23 5.1.19 Pacemaker Synopsis 24

5.2 PACING LEADS 26 5.2.1 Stelix II BRF25D - BRF26D 26 5.2.2 Stelid II BJF24D - BJF25D 26 5.2.3 Stelid II BTF25D - BTF26D 27 5.2.4 Stelid II UTF25D - UTF26D 27 5.2.5 Stelix BR45D - BR46D 28 5.2.6 Stelid BT45D - BT46D 28 5.2.7 Stelid BS45D - BS46D 29 5.2.8 BEST mini 29 5.2.9 S200 AB 30 5.2.10 S 80 JB 30 5.2.11 HEPTA 4B 31

Sorin Group CRM 3

5.2.12 S 80 TB 31 5.2.13 S 80 UTS 32 5.2.14 Pacing Lead Synopsis 33

6 FIELD SAFETY NOTICES 34

6.1 CARDIOVERTER DEFIBRILLATORS 34 6.1.1 Alto and Alto 2, Group 1 34 6.1.2 Alto and Alto 2, Group 2 37 6.1.3 Alto and Alto 2, Group 3 40

6.2 PACEMAKERS 43 6.2.1 Symphony and Rhapsody, Group 1 43 6.2.2 Symphony and Rhapsody, Group 2 46 6.2.3 Neway DR 49

6.3 STELID BS45D LEADS 49

7 LIST OF QA LOCAL REPRESENTATIVES 50

Sorin Group CRM 4

1 Sorin Group Commitment to Quality

Quality and safety are top priorities for Sorin Group CRM. Our devices are designed and built to save lives; therefore Sorin Group CRM strives for the highest levels of performance and quality. This November Edition of Sorin Group CRM’s 2007 Product Performance Report embodies our commitment to update product performance data regularly and communicate them to physicians and patients. Because at Sorin we believe that every patient is important and should be treated equally, and because we aim at being fully transparent with our physicians and patients, Sorin CRM’s product performance reports provide performance data on CRM devices implanted worldwide. Our performance reports are published online semi-annually at www.sorin-crm.com. This new edition of the report includes performance data collected through June 30, 2007. This report was reviewed by an independent Product Performance Review Board. We continually seek your input to help us improve our product performance. We encourage you to provide your comments and suggestions to your local representative. Your input will help us communicate vital product performance information. We also urge you to inform your local representative immediately about any indication of potential device malfunction if this should occur with any of our products. We thank you for your support.

Peter Jacobson VP Quality Assurance and Regulatory Affairs

Sorin Group CRM 5

2 Definitions and methods This November Edition of the 2007 CRM Product Performance Report presents performance and Field Safety Notice summaries for Sorin Group’s most recent pacemakers, implantable cardioverter defibrillators (ICDs), cardiac resynchronization devices and leads. Sorin Group CRM presents worldwide data in its Product Performance Report because the majority of its products are used outside the US and are released for distribution there years earlier than in the US; therefore physicians and regulators are better informed, and sooner informed, with worldwide data. This performance report calculates cumulative survival probability using the standard actuarial method with confidence intervals using Greenwood’s method. This report was prepared in accordance with ISO 5841-2:2000, an international standard for reporting the clinical performance of populations of pulse generators or leads. Cumulative survival probability is the estimated probability of a unit’s surviving from the time of implant to the end of a given interval without device malfunction. This estimation includes only events confirmed by the manufacturer’s analysis, for which records include an implant date and an event or explant date. Because not all devices are returned to Sorin for analysis, limitations of passive follow up are encountered. Data on survival from malfunction (excluding normal battery depletion) are based on returned product analysis. Sorin does not utilize any prospective, active device follow-up to assess device survival. As such, the survival data probably underestimate malfunction rates. Device malfunction occurs when a device is out of specification after implant, except because of normal battery depletion. Out of specification means having one or more characteristics outside the limits established by the manufacturer for clinical use. According to the international standard ISO 5841-2:2000, normal battery depletion occurs when a device is out of specification after implant because it has reached the point in the service life at which the manufacturer recommends its replacement. Practically, normal battery depletion data analysis uses U.S. device-tracking data to estimate the fraction of exposed devices withdrawn each month for normal battery depletion. When the devices are not returned, the physician’s opinion – as documented in the device tracking database – determines whether the explant is attributed to normal battery depletion; otherwise, the determination is based on returned device analysis. Malfunctions for any model are further separated in malfunctions with compromised therapy and malfunctions without compromised therapy. Malfunction with compromised therapy is the condition when a device is confirmed through laboratory analysis to have malfunctioned 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; accelerated current drain such that low battery was not detected before loss of therapy; sudden malfunction during defibrillation therapy resulting in aborted therapy delivery; intermittent malfunction in which therapy is compromised while in the malfunction state. Malfunction without compromised therapy is the condition when a device is confirmed through laboratory analysis to have malfunctioned in a manner that did not compromise pacing or defibrillation therapy while implanted and in service. Malfunctions in which critical patient-protective pacing and defibrillation therapies remain available are included here. Examples include (but are not limited to): error affecting diagnostic functions, data storage; malfunction of a component that causes the battery to lose power quickly enough to result in premature battery depletion, but slowly enough that the condition is detected through normal follow-up before therapy is lost; telemetry failure.

Sorin Group CRM 6

Survival graphs: Each survival graph shows “cumulative survival” on its Y-axis. This refers to the probability that the device will remain in the body without malfunction during the interval from the time the device is implanted up until the point in time shown on the X-axis. Cumulative survival graphs are presented separately for non-Field Safety Notice and Field Safety Notice device populations (when applicable), to provide the healthcare community with clinically relevant, patient-specific device performance. Each Field Safety Notice is described in the last section (Section 6). Here is an example of the presentation format used: TALENT DR 213

Cutoff date: 30-Jun-2007

Analysis stops at 72 months

or < 500 active implants.

Estimated Estimated

Worldwide active normal batt. Worldwide

implants implants depletion malfunctions 1 2 3 4 5 6 7 8

39328 26520 7427 49 99.96% 99.93% 99.90% 99.89% 99.87% 99.85%

Upper confidence interval (+) 0.01% 0.02% 0.03% 0.03% 0.03% 0.04%

Lower confidence interval (-) 0.02% 0.03% 0.04% 0.04% 0.04% 0.05%

49

38

11Devices without compromised therapy

with 95 % confidence interval, as a function of years after implant

Cumulative survival from malfunction (excluding normal battery depletion)

Worldwide malfunctions

Devices with compromised therapy

30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8

Years after start of exposure

Cum

ulative survival .

Cumulative survival from malfunction and normal battery depletion

Cumulative survival from malfunction

Here is a key to the information in the sample presentation above:

Talent DR 213

Model designation for device covered by each cumulative survival graph appears at the upper left of the corresponding graph.

Cutoff date The graph and table contain all applicable data in the manufacturer’s sales and analysis records as of the cutoff date shown at the lower left of the corresponding graph.

Analysis stops at 72 months or < 500 active implants

Cumulative survival probability is presented for device models with 500 or more estimated active implants and for any devices covered by a Field Safety Notice regardless of the number of estimated active implants.

Worldwide implants Number of devices of the models covered by the graph that have been implanted worldwide.

Sorin Group CRM 7

Estimated active implants Number of devices estimated in service worldwide at the

cutoff date. Because the manufacturer collects worldwide data passively, i.e. uses returned products to assess product performance, underreporting could bias the analysis. To correct for this potential bias, the analysis uses device-tracking data collected in the United States for same or similar types of devices, to estimate the fraction of exposed devices withdrawn each month for reasons not related to the functioning of the device, and for loss to follow-up.

Estimated normal battery depletion Number of devices estimated out of service worldwide due to normal battery depletion at the cutoff date. To correct for potential bias due to underreporting of normal battery depletion worldwide, when the same or similar models are marketed in the United States, the analysis uses U.S. device-tracking data to estimate the fraction of exposed devices withdrawn each month for normal battery depletion: When the devices are not returned, the physician’s opinion – as documented in the device tracking database – determines whether the explant is attributed to normal battery depletion; otherwise, the determination is based on returned device analysis. “Estimated normal battery depletion” is shown only for device models marketed in the United States.

Worldwide malfunctions Number of devices confirmed out of specification worldwide after implant, except because of normal battery depletion.

Years after start of exposure Number of years the device remains in the body after the device is implanted. The analysis uses the date of sale as a surrogate for date of implant. The survival analysis calculates time to the nearest day. However, for convenience, the graphs and tables report time in years and the analysis stops at 6 years (72 months).

Cumulative survival curves

Each survival graph contains the survival curve for freedom from malfunction, in red. When the device is marketed in the United States, a second survival curve for normal battery depletion and malfunction is shown on the same graph (the lower curve), in black. A table provides annual values corresponding to the upper curve, with confidence limits.

Devices with/without compromised therapy The number of malfunctions with and without compromised therapy is documented in a table below the survival curves data.

Sorin Group CRM 8

3 Cardiac Resynchronization Therapy (CRT)

3.1 Cardiac Resynchronization Therapy Defibrillators (CRT-D)

3.1.1 Ovatio CRT 6750 OVATIO MSP




Estimated

Worldwide active Worldwide

implants implants malfunctions 1 2 3 4 5 6 7 81405 1368 0 100.00%

Upper confidence interval (+)

Lower confidence interval (-)



30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

3.1.2 Alto MSP 627 - 617 A Field Safety Notice was issued for a limited number of Alto 2 MSP 627 and Alto MSP 617 devices. Please refer to Section 6.1.

Sorin Group CRM 9

3.2 Cardiac Resynchronization Therapy Pacemakers (CRT-P)

3.2.1 Talent 3 MSP 353 - MSP AF 343 - MSP 313 TALENT 3 MSP 353

TALENT MSP 313

TALENT MSP AF 343




Estimated


implants implants malfunctions 1 2 3 4 5 6 7 81478 1208 3 99.79% 99.79% 99.79%

Upper confidence interval (+) 0.14% 0.14% 0.14%

Lower confidence interval (-) 0.44% 0.44% 0.44%

3

2






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 10

3.3 Cardiac Resynchronization Therapy Leads

3.3.1 Situs OTW UW28D SITUS OTW UW28D




Estimated







30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

3.3.2 Situs LV UC28D - UL28D SITUS LV UC28D

SITUS LV UL28D




Estimated


implants implants malfunctions 1 2 3 4 5 6 7 8

1994 1459 0 100.00% 100.00% 100.00% 100.00%





30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 11

4 Tachycardia Therapy

4.1 Cardioverter Defibrillators (ICDs)

4.1.1 Ovatio DR 6550 - VR 6250 OVATIO DR 6550

OVATIO VR 6250




Estimated Estimated


implants implants depletion malfunctions 1 2 3 4 5 6 7 85096 5000 5 0 100.00%





30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 12

4.1.2 Alto 2 DR 624 - VR 625 ALTO 2 DR 624

ALTO 2 VR 625




Estimated Estimated



2664 2567 7 11 99.81% 99.53%

Upper confidence interval (+) 0.11% 0.21%

Lower confidence interval (-) 0.27% 0.38%

11

7






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

A Field Safety Notice was issued for a limited number of Alto 2 DR 624 and Alto 2 VR 625 devices. Please refer to Section 6.1.

4.1.3 Alto DR 614 - VR 615

A Field Safety Notice was issued for a limited number of Alto DR 614 and Alto VR 615 devices. Please refer to Section 6.1.

Sorin Group CRM 13

4.2 Defibrillation Leads

4.2.1 Isoline 2CR6 - 2CT6 ISOLINE 2CR6

ISOLINE 2CT6




Estimated



2053 2012 2 99.90%

Upper confidence interval (+) 0.08%

Lower confidence interval (-) 0.30%

2

2






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

4.2.2 Swift 4041

SWIFT 1CT 4041




Estimated



2282 2112 0 100.00% 100.00% 100.00% 100.00%





30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 14

5 Bradycardia Therapy

5.1 Pacemakers

5.1.1 Symphony DR 2550 - SOLE DR SOLE DR

SYMPHONY DR 2550




Estimated Estimated


implants implants depletion malfunctions 1 2 3 4 5 6 7 865317 63922 100 11 99.98% 99.98% 99.95%



11

5






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

A Field Safety Notice was issued for a limited number of Symphony DR 2550 devices. Please refer to Section 6.2.

Sorin Group CRM 15

5.1.2 Symphony D 2450 - VDR 2350 - SOLE VDR SOLE VDR

SYMPHONY D 2450

SYMPHONY VDR 2350




Estimated


implants implants malfunctions 1 2 3 4 5 6 7 86704 6032 2 99.97% 99.97%



2

1






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

5.1.3 Symphony SR 2250 - SOLE SR SOLE SR

SYMPHONY SR 2250




Estimated Estimated


implants implants depletion malfunctions 1 2 3 4 5 6 7 817307 17162 13 2 99.99% 99.99%



2

2






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 16

5.1.4 Rhapsody DR 2510 - SR 2210 - + DR 2530 RHAPSODY DR 2510

RHAPSODY SR 2210

RHAPSODY+ DR 2530




Estimated Estimated



18167 17833 41 5 99.99% 99.97% 99.95%



5

4






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

A Field Safety Notice was issued for a limited number of Rhapsody DR 2510, Rhapsody SR 2210 and Rhapsody + DR 2530 devices. Please refer to Section 6.2.

5.1.5 Rhapsody D 2410 - S 2130 RHAPSODY D 2410

RHAPSODY S 2130




Estimated





10

9






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

A Field Safety Notice was issued for a limited number of Rhapsody 2410 devices. Please refer to Section 6.2.

Sorin Group CRM 17

5.1.6 Talent 3 DR 253 - VDR 263 TALENT 3 DR 253

TALENT 3 VDR 263




Estimated





6

3






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

5.1.7 Talent II DR 233 TALENT II DR 233




Estimated Estimated


implants implants depletion malfunctions 1 2 3 4 5 6 7 812169 10011 1191 6 99.98% 99.97% 99.97% 99.97% 99.94%

Upper confidence interval (+) 0.02% 0.02% 0.02% 0.02% 0.04%

Lower confidence interval (-) 0.05% 0.06% 0.06% 0.06% 0.12%

6

1






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 18

5.1.8 Talent II SR 133 TALENT II SR 133




Estimated Estimated





2

1






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

5.1.9 Talent DR 213 TALENT DR 213




Estimated Estimated


implants implants depletion malfunctions 1 2 3 4 5 6 7 839328 26520 7427 49 99.96% 99.93% 99.90% 99.89% 99.87% 99.85%



49

38






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 19

5.1.10 Talent AF 243 TALENT AF 243




Estimated


implants implants malfunctions 1 2 3 4 5 6 7 82557 1769 3 99.92% 99.92% 99.92% 99.87%

Upper confidence interval (+) 0.06% 0.06% 0.06% 0.09%

Lower confidence interval (-) 0.23% 0.23% 0.23% 0.28%

3

1






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

5.1.11 Talent D 210 TALENT D 210




Estimated


implants implants malfunctions 1 2 3 4 5 6 7 86915 4525 2 100.00% 99.98% 99.98% 99.98% 99.96% 99.96%



2

2






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 20

5.1.12 Talent SR 113 TALENT SR 113




Estimated Estimated





3

3






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

5.1.13 Brio DR 212 - DR 222 BRIO DR 212

BRIO DR 222




Estimated Estimated





6

5






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 21

5.1.14 Brio D 220 BRIO D 220




Estimated Estimated





7

3






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

5.1.15 Brio SR 112 BRIO SR 112




Estimated Estimated





3

2






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 22

5.1.16 Elect D - DR - SR - VDR ELECT D

ELECT DR

ELECT DRM

ELECT SR

ELECT SRC

ELECT VDR




Estimated





50

29






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

5.1.17 Diapason - Elect XS DIAPASON

DIAPASON C

ELECT XS

ELECT XS C

ELECT XS PLUS

ELECT XS PLUS C




Estimated





3

1






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 23

5.1.18 Neway - NewLiving NEWAY D

NEWAY DR

NEWAY SR

NEWAY VDR

NEWLIVING CHF

NEWLIVING DR

NEWLIVING SR




Estimated





11

3






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

A Field Safety Notice was issued for a limited number of Neway DR devices. Please refer to Section 6.2.

Sorin Group CRM 24

5.1.19 Pacemaker Synopsis The tables presented below summarize device information and cumulative survival probability from malfunction.

Market Estimated Estimated Devices with Devices without

release Worldwide active normal batt. Worldwide compromised compromised

Models Family date (CE) implants implants depletion malfunctions therapy therapySYMPHONY DR 2550, Symphony Mar-02 65317 63922 100 11 5 6

SOLE DR -

SYMPHONY VDR 2350, Symphony Apr-03 6704 6032 - 2 1 1

SYMPHONY D 2450, Apr-03

SOLE VDR -

SYMPHONY SR 2250, Symphony Oct-02 17307 17162 13 2 2 0

SOLE SR -

RHAPSODY DR 2510, Rhapsody May-03 18167 17833 41 5 4 1

RHAPSODY SR 2210, Jun-03

RHAPSODY+ DR 2530 May-03

RHAPSODY D 2410, Rhapsody May-03 9000 7824 - 10 9 1

RHAPSODY S 2130 Jun-03

TALENT 3 DR 253, Talent Jul-02 9432 7417 - 6 3 3

TALENT 3 VDR 263 Dec-02

TALENT II DR 233 Talent Jul-00 12169 10011 1191 6 1 5

TALENT II SR 133 Talent Sep-01 6579 5881 61 2 1 1

TALENT DR 213 Talent Nov-97 39328 26520 7427 49 38 11

TALENT AF 243 Talent Mar-01 2557 1769 - 3 1 2

TALENT D 210 Talent Jun-98 6915 4525 - 2 2 0

TALENT SR 113 Talent Nov-98 10229 7725 359 3 3 0

BRIO DR 212, Brio May-98 19924 13038 2502 6 5 1

BRIO DR 222 -

BRIO D 220 Brio Feb-99 9701 6205 1869 7 3 4

BRIO SR 112 Brio Nov-98 6713 4927 68 3 2 1

ELECT D, Elect Apr-02 19733 13647 - 50 29 21

ELECT DR, Apr-02

ELECT DRM, Apr-02

ELECT SR, Apr-02

ELECT SRC, Apr-02

ELECT VDR Apr-02

DIAPASON, Elect Apr-05 48923 36922 - 3 1 2

DIAPASON C, Apr-05

ELECT XS, Apr-05

ELECT XS C, Apr-05

ELECT XS PLUS, Apr-05

ELECT XS PLUS C Apr-05

NEWAY D, Neway Feb-03 39251 33384 - 11 3 8

NEWAY DR, Dec-02

NEWAY SR, Feb-03

NEWAY VDR, Feb-03

NEWLIVING CHF, Mar-05

NEWLIVING DR, Dec-04

NEWLIVING SR Aug-05

Sorin Group CRM 25

Models 1 2 3 4 5 6SYMPHONY DR 2550, 99.98% 99.98% 99.95%

SOLE DR

SYMPHONY VDR 2350, 99.97% 99.97%

SYMPHONY D 2450,

SOLE VDR

SYMPHONY SR 2250, 99.99% 99.99%

SOLE SR

RHAPSODY DR 2510, 99.99% 99.97% 99.95%

RHAPSODY SR 2210,

RHAPSODY+ DR 2530

RHAPSODY D 2410, 99.94% 99.85% 99.76%

RHAPSODY S 2130

TALENT 3 DR 253, 99.95% 99.95% 99.94%

TALENT 3 VDR 263

TALENT II DR 233 99.98% 99.97% 99.97% 99.97% 99.94%

TALENT II SR 133 99.98% 99.97% 99.97% 99.97% 99.97%

TALENT DR 213 99.96% 99.93% 99.90% 99.89% 99.87% 99.85%

TALENT AF 243 99.92% 99.92% 99.92% 99.87%

TALENT D 210 100.00% 99.98% 99.98% 99.98% 99.96% 99.96%

TALENT SR 113 100.00% 99.99% 99.97% 99.97% 99.97% 99.97%

BRIO DR 212, 99.99% 99.98% 99.97% 99.97% 99.96% 99.96%

BRIO DR 222

BRIO D 220 99.98% 99.98% 99.93% 99.92% 99.92% 99.92%

BRIO SR 112 99.97% 99.97% 99.95% 99.95% 99.95% 99.95%

ELECT D, 99.97% 99.95% 99.89% 99.80% 99.52% 99.42%

ELECT DR,

ELECT DRM,

ELECT SR,

ELECT SRC,

ELECT VDR

DIAPASON, 100.00% 100.00% 99.99% 99.99% 99.99% 99.99%

DIAPASON C,

ELECT XS,

ELECT XS C,

ELECT XS PLUS,

ELECT XS PLUS C

NEWAY D, 99.99% 99.99% 99.98% 99.47%

NEWAY DR,

NEWAY SR,

NEWAY VDR,

NEWLIVING CHF,

NEWLIVING DR,

NEWLIVING SR



Sorin Group CRM 26

5.2 Pacing Leads

5.2.1 Stelix II BRF25D - BRF26D STELIX II BRF25D

STELIX II BRF26D




Estimated



4076 3531 1 99.97% 99.97%



1

1






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

5.2.2 Stelid II BJF24D - BJF25D STELID II BJF24D

STELID II BJF25D




Estimated



17151 14179 1 99.99% 99.99% 99.99% 99.99%



1

0






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 27

5.2.3 Stelid II BTF25D - BTF26D STELID II BTF25D

STELID II BTF26D




Estimated



53537 41670 1 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%



1

1






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

5.2.4 Stelid II UTF25D - UTF26D STELID II UTF25D

STELID II UTF26D




Estimated



5256 3720 0 100.00% 100.00% 100.00% 100.00% 100.00%





30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 28

5.2.5 Stelix BR45D - BR46D STELIX BR45D

STELIX BR46D




Estimated



9109 6332 0 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%





30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

5.2.6 Stelid BT45D - BT46D STELID BT45D

STELID BT46D




Estimated



32776 20491 2 99.99% 99.99% 99.99% 99.99% 99.99% 99.99%



2

2






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 29

5.2.7 Stelid BS45D - BS46D STELID BS45D

STELID BS46D




Estimated





1

1






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

A Field Safety Notice was issued for a limited number of Stelid BS45D leads. Please refer to Section 6.3.

5.2.8 BEST mini MiniBEST




Estimated


implants implants malfunctions 1 2 3 4 5 6 7 82934 2024 0 100.00% 100.00% 100.00% 100.00% 100.00%





30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 30

5.2.9 S200 AB S 200 AB




Estimated





3

2






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

5.2.10 S 80 JB S 80 JB




Estimated





1

1






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 31

5.2.11 HEPTA 4B HEPTA 4B




Estimated


implants implants malfunctions 1 2 3 4 5 6 7 88925 6599 11 99.95% 99.86% 99.84% 99.84% 99.84%



11

11






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

5.2.12 S 80 TB S 80 TB




Estimated





8

7






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 32

5.2.13 S 80 UTS S 80 UTS




Estimated





1

1






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 33

5.2.14 Pacing Lead Synopsis The tables presented below summarize device information and cumulative survival probability from malfunction.

Market Estimated Devices with Devices without

release Worldwide active Worldwide compromised compromised

Models Family date (CE) implants implants malfunctions therapy therapySTELIX II BRF25D, Stelix Dec-01 4076 3531 1 1 0

STELIX II BRF26D Dec-01

STELID II BJF24D, Stelid Feb-01 17151 14179 1 0 1

STELID II BJF25D Feb-01

STELID II BTF25D, Stelid Sep-99 53537 41670 1 1 0

STELID II BTF26D Sep-99

STELID II UTF25D, Stelid Jun-00 5256 3720 0 0 0

STELID II UTF26D Jun-00

STELIX BR45D, Stelix Mar-99 9109 6332 0 0 0

STELIX BR46D Mar-99

STELID BT45D, Stelid Jul-97 32776 20491 2 2 0

STELID BT46D Jul-97

STELID BS45D, Stelid May-97 15855 11019 1 1 0

STELID BS46D May-97

MiniBEST Best Jul-05 2934 2024 0 0 0

S 200 AB S 200 Dec-04 14592 8884 3 2 1

S 80 JB S 80 Dec-04 22885 14102 1 1 0

HEPTA 4B Hepta May-05 8925 6599 11 11 0

S 80 TB S 80 Dec-04 92334 56753 8 7 1

S 80 UTS S 80 Dec-04 14124 8912 1 1 0

Models 1 2 3 4 5 6STELIX II BRF25D, 99.97% 99.97%

STELIX II BRF26D

STELID II BJF24D, 99.99% 99.99% 99.99% 99.99%

STELID II BJF25D

STELID II BTF25D, 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

STELID II BTF26D

STELID II UTF25D, 100.00% 100.00% 100.00% 100.00% 100.00%

STELID II UTF26D

STELIX BR45D, 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

STELIX BR46D

STELID BT45D, 99.99% 99.99% 99.99% 99.99% 99.99% 99.99%

STELID BT46D

STELID BS45D, 99.99% 99.99% 99.99% 99.99% 99.99% 99.99%

STELID BS46D

MiniBEST 100.00% 100.00% 100.00% 100.00% 100.00%

S 200 AB 100.00% 99.98% 99.98% 99.98% 99.98% 99.98%

S 80 JB 100.00% 100.00% 99.99% 99.99% 99.99% 99.99%

HEPTA 4B 99.95% 99.86% 99.84% 99.84% 99.84%

S 80 TB 99.99% 99.99% 99.99% 99.99% 99.99% 99.99%

S 80 UTS 99.99% 99.99% 99.99% 99.99% 99.99% 99.99%



Sorin Group CRM 34

6 Field Safety Notices

6.1 Cardioverter Defibrillators

6.1.1 Alto and Alto 2, Group 1 Original date of Field safety notice: February 2004 Field safety notice description A Field Safety Notice was issued for this group of devices that were manufactured before April 17, 2003 (Group 1). The notification states that premature battery depletion and/or prolonged charge time can occur due to metal migration, in a limited number of Alto and Alto 2 implantable cardioverter defibrillators (models DR 614, VR 615, MSP 617, DR 624, and VR 625). Premature battery depletion and/or prolonged charge time can result in unavailability of pacing, cardioversion, and defibrillation therapy. This condition can occur between two follow up visits. No permanent adverse effect on a patient’s health has been reported. Patient recommendations The notification recommends strictly observing a follow-up interval of three (3) months for these devices, in conformance with recommendations provided in the user’s manual. Depending on the circumstances, those patients known to have frequent recent episodes of ventricular fibrillation might be at greater risk if the device does not perform as expected between follow-up visits. Those patients could require prophylactic explantation or more frequent visits. Other patients, including pacemaker-dependent patients, could also benefit from prophylactic explantation or more frequent visits.

Sorin Group CRM 35

6.1.1.1 Alto MSP 617 group 1 Alto MSP 617 - GR 1


Estimated



50 41 1 100.00% 97.90% 97.90% 97.90% 97.90%



1

0






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

.

6.1.1.2 Alto DR 624 - DR 614 group 1 Alto DR 614 - GR 1

Alto DR 624 - GR 1


Estimated Estimated





164

94






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 36

6.1.1.3 Alto VR 625 - VR 615 group 1 Alto VR 615 - GR 1

Alto VR 625 - GR 1


Estimated Estimated





42

24






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 37

6.1.2 Alto and Alto 2, Group 2 Original date of Field Safety Notice: July 2005 Field Safety Notice description The Field Safety Notice described above for Group 1 was extended to this second group of devices manufactured from April 17, 2003 through July 31, 2003 (Group 2). No permanent adverse effect on a patient’s health has been reported in this group. Patient recommendations The Field Safety Notice recommends strictly observing a follow-up interval of three (3) months for these devices, in conformance with recommendations provided in the user’s manual. Depending on the circumstances, those patients known to have frequent recent episodes of ventricular fibrillation might be at greater risk if the device does not perform as expected between follow-up visits. Those patients could require prophylactic explantation or more frequent visits. Other patients, including pacemaker-dependent patients, could also benefit from prophylactic explantation or more frequent visits.

Sorin Group CRM 38

6.1.2.1 Alto MSP 617 group 2 Alto MSP 617 - GR 2


Estimated



48 40 2 97.87% 95.69% 95.69% 95.69%



2

0






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .


Alto DR 624 - GR 2


Estimated Estimated


implants implants depletion malfunctions 1 2 3 4 5 6 7 8315 238 17 28 99.03% 94.74% 91.32% 90.61%



28

13






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 39


Alto VR 625 - GR 2


Estimated Estimated





2

2






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 40

6.1.3 Alto and Alto 2, Group 3 Original date of Field Safety Notice: July 2005 Field Safety Notice description The Field Safety Notice described above for Group 1 was extended to this third group of devices, manufactured from August 2003 through August 2004 (Group 3). No permanent adverse effect on a patient’s health has been reported in this group. Although a Field Safety Notice was issued for this group, performance compares favorably with recently-published data1 indicate that the average malfunction rate for all ICDs is approximately 1% per year. Patient recommendations In Group 3, the Field Safety Notice recommends strictly observing a follow-up interval of three (3) months for these devices, in conformance with recommendations provided in the user’s manual.

Sorin Group CRM 41

6.1.3.1 Alto MSP 627 - MSP 617 group 3 Alto MSP 617 - GR 3

Alto MSP 627 - GR 3


Estimated





1

1






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .


Alto DR 624 - GR 3


Estimated Estimated





18

13






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 42


Alto VR 625 - GR 3


Estimated Estimated





3

2






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 43

6.2 Pacemakers

6.2.1 Symphony and Rhapsody, Group 1 Original date of Field Safety Notice: October 2005 Field Safety Notice description A Field Safety Notice was issued for this group of devices. A no-output condition was observed in a limited number of Symphony or Rhapsody pacemakers (models Symphony DR 2550, Symphony SR 2250, Rhapsody DR+ 2530, Rhapsody DR 2510, Rhapsody D 2410, Rhapsody SR 2210), due to metal migration caused by a manufacturing process performed systematically in this population, identified as Group 1. No injury or death has been reported in this group. Patient recommendations The notification states that no measurable change in device characteristics was identified that could warn of an impending incident. Consequently, the Field Safety Notice does not recommend more frequent monitoring. Depending on the circumstances, pacemaker-dependent patients implanted with units manufactured in this group could require prophylactic replacement.

Sorin Group CRM 44

6.2.1.1 Symphony DR 2550 Group 1 SYMPHONY DR 2550 - GR 1


Estimated Estimated



693 608 27 24 99.28% 98.24% 96.59%



24

19






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

6.2.1.2 Rhapsody DR 2510 - SR 2210 - + DR 2530 group 1 RHAPSODY + DR 2530 - GR 1

RHAPSODY DR 2510 - GR 1

RHAPSODY SR 2210 - GR 1


Estimated Estimated





10

8






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 45

6.2.1.3 Rhapsody D2410 Group 1 RHAPSODY D 2410 - GR 1


Estimated





1

1






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 46

6.2.2 Symphony and Rhapsody, Group 2 Original date of Field Safety Notice: October 2005 Field Safety Notice description A manufacturing process that caused malfunctions described in Group 1 above was also performed for some devices in this second population identified as Group 2, although no similar malfunctions have been reported. Consequently, the Field Safety Notice described above also included Group 2. Patient recommendations No measurable change in device characteristics was identified that could warn of an impending incident. Consequently, the Field Safety Notice does not recommend more frequent monitoring. For Group 2, because recently-published data indicate that the average malfunction rate for all pacemakers is approximately 0.15 % per year 1, and because of the small but non-zero risk associated with device replacement, the Field Safety Notice does not recommend prophylactic replacement. REFERENCE: 1 Maisel WH, Pacemaker and ICD Generator Malfunctions, HRS Policy Conference on Pacemaker and ICD Performance, September 16, 2005.

Sorin Group CRM 47

6.2.2.1 Symphony DR 2550 Group 2 SYMPHONY DR 2550 - GR 2


Estimated Estimated





2

2






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

6.2.2.2 Rhapsody DR 2510 - SR 2210 group 2 RHAPSODY DR 2510 - GR 2

RHAPSODY SR 2210 - GR 2


Estimated Estimated


implants implants depletion malfunctions 1 2 3 4 5 6 7 8301 277 7 0 100.00% 100.00% 100.00% 100.00%



0

0






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 48

6.2.2.3 Rhapsody D2410 Group 2 RHAPSODY D 2410 - GR 2


Estimated





0

0






30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8


Cum

ulative survival .

Sorin Group CRM 49

6.2.3 Neway DR

Original date of Field Safety Notice: July 2007

Field Safety Notice description A Field Safety Notice was issued in relation to a limited series of 45 cardiac pacemakers, Neway DR model, distributed in Europe. The notification states that these devices contained a version of a microcontroller integrated circuit that did not allow automatic storing of the data coming from the intracardiac EGM (IEGM) into the device memory. To overcome this limitation, storing of data was performed by a dedicated software routine. This software routine caused additional current drain that reduced longevity in devices with IEGM activated, compared to the devices with the IEGM deactivated. Available programmer software did not take into account the additional current required for the IEGM function when estimating the remaining longevity.

Patient Recommendations Revised programmer software (SmartView 2.06 for Orchestra programmer - version 3.6.04 for PMP 2000 programmer or higher versions) was distributed to calculate the remaining longevity accurately with or without IEGM enabled. For all of the devices included in this field safety notice, a prompt follow-up visit and device interrogation was recommended utilizing this revised programmer software.

6.3 Stelid BS45D leads Original date of Field Safety Notice: December 2006 Field Safety Notice description A Field Safety Notice was issued for a limited number of Stelid BS45D leads (54 units). A loss of pacing and sensing condition was observed on one BS45D lead, due to an incorrect crimping operation for the fixed screw during the manufacturing of an isolated lot of BS45D. No deterioration in patient’s health was reported as a result of the defect. Patient recommendations ELA recommends performing a follow up visit every six months over the first two years after implantation. The lead electrical performance and stability should be checked during each follow up: pacing/sensing threshold and pacing impedance.

Sorin Group CRM 50

7 List of QA local representatives Country & address

Tel and fax numbers

Local contacts

Belgium Sorin Group Belgium Excelsiorlaan 33 1930 Zaventem

� +32-2 247 78 90 � +32-2 245 17 92

J.Bakers

Canada Sorin Group Canada Inc 280 Hillmount Road Unit 8 Markhan, Ontario L6C3A1

�� +1-416 751 8787 � +1-416 751 9849

R. Gordon

France Sorin Group France Centre d’Affaires La Boursidière Bât Jura 92357 Le Plessis Robinson Cedex

� +33-1 46 01 89 42 � +33-1 46 01 89 47

G. Dudley-Casses

Germany Sorin Group Deutschland GmbH Lindberghstrasse 25 D-80939 München

� +49-89 32 301 353 � +49 89 32301 404

L. Pricelius

Italy Sorin Group Italia via Benigno Crespi 17 20159 Milan

� +39.02.69465211 � +39.02.69465311

A. Pinciroli

Japan Sorin Biomedica Japan K.K. NBF Akasaka Sanno Square Bld 8F 2-2-12, Akasaka, Minato-ku Tokyo 107-0052

�� +81-3 3560 8146 � +81-3 3560 2020

K. Numata

Netherlands Sorin Group Nederland BV Postbus 12060 1100 AB Amsterdam

� +31-20311 32 11 � +31-20311 32 19

K. Feller

Portugal ELA Medical Cormedica R. Proletariado 1 Quinta do Paizinho 2794-076 Carnaxide

� +351-21 425 5239 � +351-21 425 5218

J. Venancio

Scandinavia Medevivägen 78 591 33 MOTALA Sweden

� +46 708 52 99 61 � +46 406 99 27 71

P. Halenius

Spain Sorin Group Espana, S.L. Edificio Trade Center II Avda. De les Crts Catalanes, 8, 3° 08173 Sant Cugat del Vallès Barcelona

� +34-93 544 22 44 � +34-93 675 22 52

M.J. Iglesias

Switzerland SORIN GROUP International AG Seefeldstrasse 69 CH-8008 ZÜRICH

� +41-43 488 36 20 � +41-43 488 35 37

P.Heizmann

UK Sorin Group UK Ltd 1370 Montpellier Court Gloucester Business Park Gloucester GL3 4AH

� +44 01452 638500 � +44 01452 638530

P. Gadd

USA ELA Medical Inc 2950 Xenium Lane North Plymouth, 55441 (MN)

� +1 763/519-9411 � +1 877/443-3134

C. Doty

Sorin Group CRM 51

Editor Peter JACOBSON, VP Quality Assurance and Regulatory Affairs of CRM Business Unit Independent Product Performance Review Board Etienne ALIOT, M.D, Nancy, France Philip R. ERSHLER Ph.D. Bioengineering, Salt Lake City, United States Roger A. FREEDMAN, M.D., Salt Lake City, Utah, United States Howard MANN, M.D., Salt Lake City, Utah, United States Greg STODDARD, MPH, Salt Lake City, Utah, United States Sorin CRM Review Board André-Michel BALLESTER, CEO of Sorin Group Fred HRKAC, President of CRM Business Unit Peter JACOBSON, VP Quality Assurance and Regulatory Affairs of CRM Business Unit Authors (from Quality Assurance and Regulatory Affairs department) Chantal CADIOU Fabien OBERRIETTER David THIERMAN Sorin Group Trademarks

The following trademarks belong to Sorin Group: Alto® BEST™ Brio® Diapason™ Elect™ HEPTA™ Isoline™ Neway™ NewLiving™ Ovatio™ Rhapsody™ Situs® Stelid™ Stelix® Swift™ Symphony® S80™ S200™ Talent®

Product Performance Report

Cardiac Rhythm ManagementQuality Assurance & Regulatory Affairs

C.A. la Boursidière92357 le Plessis Robinson cedex, France

Phone: +33 (0)1 46 01 33 33Fax: +33 (0)1 46 01 36 37

www.sorin-crm.com So

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November 2007 Edit ion

Documents

November Edition of Sorin Group CRM’s 2007 Product … · 2018-06-21 · sorin group crm 2 contents 1 sorin group commitment to quality 4 2 definitions and methods 5 3 cardiac resynchronization