PATIENT LABELING · area of your brain that may alter the way you feel. Electromagnetic Interference (EMI) - Electrical or magnetic energy that is strong enough to interfere with

PATIENT LABELING

MedfronicYOUR RECLAIM DBSW THERAPY FOR OCDWith a Kinetrat or SoletraK Neurostimulator

Patient ManualRx Only

Humanitarian Device: Authorized by Federal (U.S.A.) law for useas an adjunct to medications and as an alternative to anteriorcapsulotomy for the treatment of chronic, severe, treatment-resistant obsessive compulsive disorder (OCD) in adult patientswho have failed at least three selective serotonin reuptakeinhibitors (SSRIs). The effectiveness of this device for this usehas not been demonstrated.

Medtronic®, Access®, Kinetra®, and Soletra® are registeredtrademarks of Medtronic, Inc.

Access Review' and Reclaim"' are trademarks of Medtronic,Inc.

2 (4

FAMILY MEMBERS ORCAREGIVERSPlease remember the following:* Read this patient manual thoroughly so

you can assist the patient living withReclaim OBS Therapy.

* Always tell any medical personnel thatthe patient has an implanted brainstimulator and tell them where it islocated. If medical personnel have anyquestions, they should contact Medtronicat 1-800-510-6735.

* Have the name and telephone number ofthe patient's doctor at hand if you have anyquestions or problems. Also, keep thetelephone number of Medtronic's PatientServices Department (1 -800-510-6735) incase you or medical or dental personnelhave any questions. In the case of amedical emergency, always dial 91 1.

FAMILY MEMBERS OR CAREGIVERS I3

4 I FAMILY MEMBERS OR CAREGIVERS

1 3

CONTENTS

1 GLOSSARY 112 DESCRIPTIVE INFORMATION 17

Purpose of the Device 17

Description of the Device 19

Your System Components 21

How Does Your Brain StimulationSystem Work? 24

When the Device Should Not be Used(Contraindications) 25

Risks 27

Risks of Surgery 27

Possible Side Effects 28

Possible Device Complications 30

Benefits and limitations for Reclaim DBSTherapy for OCD 31

What to Expect From Your ImplantProcedure 32

Before Surgery 32

CONTENTS 5

29

The Day of Surgery 33After Surgery 36

Healing stage 36

First programming 36

Changes in Therapy 36General Warnings 38General Precautions 40

Eiectromagnetic Interference(EMVI) 44

Living with Your Reclaim DBS Therapy:What You Should Know 46

When to Call Your Doctor 47

Recovering at Home 49

Healing 49

Medication 49Daily Activities and Exercise 49

3 OPERATING INFORMATION 51Control Devices 51

For Soletra Neurostimulator 51

6 CONTENTS

For Kinetra Neurostimulator 51

Using Your Therapy Controller 51

Using Your Control Magnet 52

Turning Your Neurostimulator On or Offwith Your Magnet 53

Carrying Your Magnet 58

Storing Your Magnet 58Expected Battery Life 60

Choosing to Turn Off or Explant theReclaim DBS System 61

Instructions on Disposing of YourDevice 61

Your Patient Identification Card 624 TROUBLESHOOTING 655 ELECTROMAGNETIC

INTERFERENCE 67About Electromagnetic Interference(EMI) 67

Theft Detectors and SecurityGates 68

CONTENTS 7

Home and Work Environments 71Interference Likely - Home and WorkEnvironment 71

Possible Interference - Home andWork Environment 72Safe from Interference - Home andWork Environment 73

Medical and Dental Environments 74Interference Likely - Medical andDental Environment 75

Possible Interference - Medical andDental Environment 77

Safe from Interference - Medical andDental Environment 79

6 COMMON QUESTIONS 81About the System and itsComponents 81Turning On and Turning Off Reclaim DBSTherapy 82

Everyday Use of Your Therapy 82

8 CONTENTS

7 QUICK LOOK-UP TABLE FORINTERFERENCE FROMEQUIPMENT 85

8 ADDITIONAL INFORMATION 93More About Reclaim DBS Therapy 93

INDEX 95

CONTENTS J 9

(A%_

10 ICONTENTS

1 GLOSSARY

Amplitude - Amplitude is the strength ofstimulation for your specific therapy. Theamplitude is measured in volts. The amplitudesetting is 1 of several that can be adjusted byyour doctor in the office or clinic using theclinician programmer.Autonomic effects - Involuntary physicaleffects of neurostimulation such as facialflushing or increased heart rate.Battery - A part of the neurostimulator thatprovides the power for your brain stimulationsystem. Neurostimulator service life dependson individual use. Neurostimulator service lifefor obsessive compulsive disorder (OCD)therapy typically ranges from 6 months to 16months.Capsulotomy - A surgical technique that isintended to lessen the symptoms of obsessivecompulsive disorder that involves thedestruction of specific groups of cells within aplace in the brain called the internal capsule.Clinician Programmer - A small computerthat is used to program the Reclaim DBS

1 GLOSSARY 11

System. The doctor can change the therapysettings using this programmer.Cognitive behavior therapy(CBT) - Psychotherapy that emphasizes thesubstitution of undesirable thinking patternswith desirable thinking patterns.Comorbid Psychiatric Disorder - Apsychiatric disorder that exists simultaneouslywith and usually independently of anotherpsychiatric disorder.Computerized Axial Tomography(CT or CAT) Scans - A test that can seeinside the brain and other parts of the body,into areas that cannot be seen with regular x-ray.Contraindications - A medical term meaningthat a procedure, device, or drug, etc. shouldalways be avoided because the risk is greaterthan any possible benefit.Control magnet - A magnet used to turn yourneurostimulator on and off.Disinhibition - The lessening of inhibitionthat results in behavior not normally engaged

12 I GLOSSARY 1

in that may go beyond accepted culturalnorms.Electroconvulsive therapy - Therapy thatuses electrodes placed on the outside of thehead to send electric current to the brain forthe treatment of certain mental disorders. Alsocalled electroshock therapy.Electrode - A metal piece near the tip of thelead. Electrodes deliver electrical pulses to anarea of your brain that may alter the way youfeel.Electromagnetic Interference (EMI) -Electrical or magnetic energy that is strongenough to interfere with or disrupt yourtherapy.Explant - The removal of an implanteddevice. Explantation requires surgery.Fluoroscopy - An x-ray procedure thatmakes it possible to see internal organs inmotion.Hole cap - A component covering the hole inyour skull that secures your lead in place.

1 GLOSSARY 13

Hypomania - A mild form of mania,characterized by hyperactivity or euphoria.Inappropriate euphoria - Feeling very goodeven when it isn't justified.Lead - Implantable component that consistsof a small cable with a set of electrodesthrough which the electrical stimulation isdelivered to a specific area of the brain.Magnetic Resonance Imaging (MRI) - Atype of scan using magnetic fields thatprovides detailed pictures of your anatomy.Neurostimulator - Device for treating aneurological condition by sending electricalimpulses to a specific area of the brain.Paraphilias - Psychosexual disorderscharacterized by deviant sexual thoughts oractions.Service life - Amount of time that the devicebattery is expected to work based on theprogrammed parameters, clinician-selectablefeatures, and how often the device is used bythe patient.Somatic psychiatric therapies - Therapiessuch as electroconvulsive therapy (sometimes

14 [GLOSSARY 1

called electroshock therapy), transcranialmagnetic stimulation, or vagus nervestimulation that may generate electromagneticinterference.Stimulation - The delivery of electricalsignals to the brain cells. The electrical signalsmay alter some of the incorrect messagesprocessed by the brain in the areas thatcontrol mood and anxiety.Stimulation target - The area of the brainwhere the application of stimulation is mosteffective.Suboptimal electrodes - Electrodes on thelead that may be less effective than otherelectrodes on the lead because of theirlocation in the brain.Surgical ablation - Surgical destruction ofbrain tissue intended to lessen the symptomsof obsessive compulsive disorder. An exampleis a capsulotomy, which is an alternative toneurostimulation therapy.Test Stimulation - The time period during thesystem implant procedure when brainstimulation is evaluated to determine how wellit controls your symptoms.

1 GLOSSARY] 15

LV Ci

Therapy controller - An electronic remotecontrol device used to turn yourneurostimulator on and off.Transcranial magnetic stimulation (TMS) -

The use of magnetic energy to stimulate thebrain for diagnostic or therapeutic purposes.Ultrasound - The use of high-frequencysound waves for diagnostic or therapeuticpurposes.

16 GLOSSARY 1

2 DESCRIPTIVE INFORMATION

Purpose of the DeviceThe Reclaim DBS System delivers electricalstimulation to the area in your brain to helpcontrol symptoms of obsessive compulsivedisorder (OCD). Electrical stimulation isdelivered to both sides of your brain to helprelieve the effects of OCD.You may be a candidate for the brainstimulation system for OCD if you:* have a diagnosis of OCD with a

documented duration of at least 5 years.* have OCD rated as severe or extreme

illness.· have comorbid depression and anxiety.* have failed to improve following treatment

with at least 3 selective serotonin reuptakeinhibitors (SSRIs).

* do not have hoarding as your primarysubclassification.

* have completed or tried to completeCognitive Behavior Therapy (CBT).

2 DESCRIPTIVE INFORMATION 1 17

5'

* have no serious psychiatric disorder inaddition to OCD (e.g. comorbid personalitydisorder) or substance abuse issues.

* meet established criteria for implantation ofa deep brain stimulation system.

* are 18 years old or older.* have not had a previous surgery to destroy

the region of the brain that will be thetarget of stimulation.

* are not pregnant.* have no other neurological disorders,

including dementia.* do not have a bleeding disorder or are not

taking blood thinners.* do not require routine MVRls.

18 2 DESCRIPTIVE INFORMATION

Description of the DeviceThe brain stimulation system is implantedinside your body. Refer to Figure 2.1. A controlmagnet or therapy controller is used to turnthe therapy on and off. The Reclaim DBSSystem is made up of 3 major parts:

LeadTargeted Areaof the BrainElectr od'e

- Etnsion

Neurostimulator

Figure 2.1 Parts of the brain stimulation systemimplanted inside your body.

* The lead is made of 4 wires contained in aplastic tube. It carries the stimulation signal

2 DESCRIPTIVE INFORMATION 19

to the 4 electrodes (platinum rings) thatdeliver stimulation to the brain tissue.About 4 inches of the lead is implantedinside the brain. The rest of the lead (about15 inches) is implanted under the skin ofthe scalp.

* The extension is made of 4 wirescontained in a tube that connects the leadto the neurostimulator. The extension isconnected to the end of the lead, justbehind the ear (or where your doctordecides is the best placement). Theextension is then tunneled under the skinof the neck down to the upper chest areato connect to the neurostimulator. For eachlead, you will have 1 extension.

· The neurostimulator contains a batterythat is the power source of your system.The neurostimulator controls thestimulation. It is implanted just under theskin in the upper chest area. The KinetraModel 7428 neurostimulator is about 3inches long, 2.4 inches high, and 0.6inches thick. The Soletra Model 7426neurostimulator is about 2.4 inches long,2.2 inches high, and 0.4 inches thick.

20 [ 2 DESCRIPTIVE INFORMATION

Your System ComponentsOne or 2 Kinetra Model 7428 or 2 SoletraModel 7426 implanted neurostimulatorsprovide stimulation for the treatment of OCD.Your system consists of 2 leads and 2extensions. Each lead connects to anextension and each extension connects to aneurostimulator.

2 DESCRIPTIVE INFORMATION I 21

Leads

Lead/ExtensionConnection

Extension Extension/NeurostimulatorConnection

Neurostimulator(Battery)

Figure 2.2 The Implanted Reclaim DBS System(with 1 neurostimulator).

22 j 2 DESCRIPTIVE INFORMATION

Leads

Lead/ExtensionConnection

Extension Extension

Extension! \ /Extension/Neurostimulator NeurostimulatorConnection Connection

Neurostimulator(Battery)

Figure 2.3 The Implanted Reclaim DBS System(with 2 neurostimulators).


%-)

How Does Your Brain StimulationSystem Work?Some of your symptoms are caused byabnormal messages being processed by yourbrain. Your brain stimulation system deliversmild electrical stimulation to an area in thebrain that controls mood and anxiety.Stimulation alters some of the messages asthey are being processed by the brain. Thismay relieve the symptoms of your disease.Your therapy helps you control symptoms. It isnot a cure. When you turn on the brainstimulation system, it will deliver stimulationthat may decrease your symptoms. Symptomswill return when the system is turned off.Significant OCD symptoms are likely to persistfollowing Reclaim DBS Therapy.The brain stimulation system is one therapythat helps you control the symptoms of yourdisease. Other therapies and options includecognitive behavior therapy (CBT), medicationtherapy, and capsulotomy.

24 F 2 DESCRIPTIVE INFORMATION

When the Device Should Not beUsed (Contraindications)Reclaim DBS Therapy for OCD should not beused for:· Patients who will be exposed to diathermy

(deep heat treatment). Inform anyonetreating you that you CANNOT have anyshortwave diathermy, microwavediathermy, or therapeutic ultrasounddiathermy (all now referred to asdiathermy) anywhere on your bodybecause you have an implantedneurostimulation system. Energy fromdiathermy can be transferred through yourimplanted system, can cause tissuedamage, and can result in severe injury ordeath.Diathermy can also damage parts of yourneurostimulation system. This can result inloss of therapy from your neurostimulationsystem, and may require additionalsurgery to remove or replace parts of yourimplanted device. Injury or damage canoccur during diathermy treatment whether


your neurostimulation system is turned"on" or "off."

· Patients who will be exposed to MagneticResonance Imaging (MRI). PerformingMRI can cause tissue lesions fromcomponent heating, especially at the leadelectrodes, resulting in serious andpermanent injury including coma,paralysis, or death.

* Patients who are unable to properlyoperate the neurostimulator.

Transcranial magnetic stimulation (TMS) iscontraindicated for use in patients with animplanted DBS system.

26 J 2 DESCRIPTIVE INFORMATION

40

Risks

Electroconvulsive Therapy (ECT) - Thesafety of ECT in patients who have animplanted deep brain stimulation (OBS)system has not been established. Inducedelectrical currents may interfere with theintended stimulation or damage theneurostimulation system componentsresulting in loss of therapeutic effect,clinically significant undesirable stimulationeffects, additional surgery for systemexplantation and replacement, orneurological injury.

Risks of Reclaim OBS Therapy can includerisks of surgery, side effects, or devicecomplications.

Risks of SurgeryImplanting the neurostimulator system carriesthe same risks associated with any other brainsurgery. Risks may include:* Paralysis, coma, and/or death* Bleeding inside the brain (stroke)


* Leakage of fluid surrounding the brain* Seizures* Infection* Allergic response to implanted materials* Temporary or permanent neurologic

complications* Confusion or attention problems* Pain at the surgery sites* Headache

Possible Side EffectsSide effects of brain stimulation may includethe following:* Suicidal ideation and depression* Increased OCD symptomsi Changes in mood (positive and negative)

* Increased anxiety* Gastrointestinal disturbances* Sensations such as tingling (paresthesia),

smell, or taste

28 1 2 DESCRIPTIVE INFORMATION

* Dizziness or lightheadedness(disequilibrium)

* Facial and limb muscle weakness or partialparalysis (paresis)

* Facial flushing or facial musclecontractions

* Jolting or shocking sensation* Numbness (hypoesthesia)* Increased heart rate* Hyperactivity or euphoria (hypomania)Your doctor should carefully monitor you forsymptoms of depression, anxiety, and/orhypomania/mania. Such symptoms mayinclude changes in sleep or eating behavior,disinhibition, anger, aggression, and apredisposition to accidents.There is also potential for brain tissue damageif the stimulation parameters are set too high.Your physician will be warned when thestimulation parameters exceed a certaincharge density.


Possible Device Complications· There may be pain, lack of healing, or

infection where the brain stimulationsystem parts are implanted.

* The brain stimulation system parts maywear through your skin, which can causean infection or scarring.

* The lead or lead/extension connector maymove. You may need surgery to re-adjustthe location.

* The brain stimulation system could stopbecause of mechanical or electricalproblems. Either of these would requiresurgery. Neurostimulator service lifedepends on individual use.Neurostimulator service life for OCDtypically ranges from 6 months to 16months.Note: Refer to "Risks of Surgery" onpage 27 and "Expected Battery Life" onpage 60.

* Your body may have an allergic reaction tothe brain stimulation system. The systemmaterials coming in contact with your

30 F 2 DESCRIPTIVE INFORMATION

tissue include titanium, polyurethane,silicone, and nylon. Your body could alsoreject the system (as a foreign body).

· There is the possibility of tissue damageresulting from the programmingparameters or a malfunction of 1 of theparts of the brain stimulation system.

Benefits and limitations forReclaim DBS Therapy for OCDReclaim DBS Therapy for OCD may help youmanage your symptoms, but it is not a cure.Significant OCD symptoms are likely to persistfollowing Reclaim DBS Therapy. When youturn on the brain stimulation system, it willdeliver stimulation that may decrease some orall of your symptoms. The stimulation mayalso make it easier for you to engage incognitive behavior therapy (CBT), which mayalso help control your symptoms. Yoursymptoms will probably return when thesystem is turned off. In some cases,symptoms may return with an intensity greaterthan was experienced prior to the systemimplant (See "Rebound Effect" on page 41).


6•

You will continue to require medications tocontrol your OCOD.What to Expect From YourImplant ProcedureProvided below is general information abouthow the Reclaim 065 System will beimplanted. Your doctor can provide you withmore specific information about your implantprocedure.

Before SurgeryThe evening before surgery, you may beinstructed to stop taking all or some of yourmedications. You will be admitted to thehospital either the night before or the morningof your surgery. You may have all or part ofyour head shaved prior to surgery to helpprevent infection.


The Day of SurgeryYour surgery may consist of these steps:1. A metal frame will be attached to your

head. The frame is a special instrumentthat allows your surgeon to find thecorrect path to the target site in yourbrain.

2. Pictures of your brain will be taken usingMRI (magnetic resonance imaging) and/or CAT (computer-aided tomography)scans. This will allow your surgeon todetermine the area in your brain wherethe leads will be placed.

3. You will then go to the operating roomwhere a small hole will be drilled in yourskull for each lead. You will receive localanesthesia before this procedure. Thishole is needed to place the lead in yourbrain. Later in the surgery, your surgeonwill cover this hole and secure the lead inplace with a separate component called ahole cap (Figure 2.4).

4. Your surgeon may test stimulate areas ofyour brain to check changes in mood oranxiety levels (ie, OCD symptoms). You


will be awake, but lightly sedated. This isso you can help determine, along withyour doctor, when your symptoms arebest controlled. Your doctor may ask youquestions about your mood.

5. When the best target in the brain islocated, the lead is then passed into thebrain. The lead's position is then held inplace with a hole cap in the hole in yourskull.

6. The metal frame is then removed fromyour head. If you do not have theextension and the neurostimulatorimplanted right away, you will typically beallowed to go home in approximately 24 to48 hours. Your doctor will decide thelength of your hospital stay.

7. When you have the extension andneurostimulator implanted, you will besedated and asleep. You will typically beallowed to go home in approximately 24 to48 hours. Your doctor will decide thelength of your hospital stay.

34 f 2 DESCRIPTIVE INFORMATION

Stimulation Target

Lead

Electrodes

Figure 2.4 The location of the lead in your brain.

2 DESCRIPTIVE INFORMATION j 35

GCq,

After SurgeryHealing stageYour doctor will decide when to turn on yourneurostimulator. It may be turned onimmediately or after healing is complete(about 4 weeks).

First programmingYour doctor (or nurse) will use a computercalled a clinician programmer to turn on yourneurostimulator. This programming sessionsets the stimulation to best control yoursymptoms and may take several hours. Youmay have to return to the clinic a few times tohave the stimulation adjusted in order toachieve the best symptom control for you,especially during the first few months afterimplant.Changes in TherapyThere may be changes in the level of yoursymptom improvement over time. Thesechanges may include:* Less relief or no symptom relief* Loss of effective stimulation


Your clinician may correct these changes byprogramming the brain stimulation systemagain. However, surgery may be required toreposition or replace the lead, replace thesystem, or remove the system. You may alsoask your doctor to turn off yourneurostimulation system.Your condition may improve, may worsen, ormay remain unchanged with stimulation.


General WarningsAlso refer to "When the Device Should Not beUsed (Contraindications)" on page 25 and"About Electromagnetic Interference (EMI)" onpage 67 for more safety information.Case Damage - If the neurostimulator isruptured or pierced after implant due tooutside forces, severe burns could result fromexposure to battery chemicals.Excessive Stimulation - There is thepossibility of brain tissue damage from highstimulation settings or a malfunction of one ofthe parts of the neurostimulator.Medications that Slow Blood Clotting - Ifyou are a candidate for implant surgery andare taking medications that slow clotting of theblood [anticoagulants (eg, aspirin, coumadin)],inform your doctor. These medicationsincrease the risk of bleeding during surgery.Side Effects During Programming or TestStimulation - During test stimulation or aprogramming session, some side effects mayoccur, including:· facial flushing or facial muscle contractions

38 1 2 DESCRIPTIVE INFORMATION

* increased heart rate* hyperactivity or euphoria (hypomania)· increased disease symptomsYour doctor will select different stimulationsettings until these side effects decrease.Because these side effects may not appearimmediately, you may be asked to remain inthe clinic for at least 30 minutes after yourprogramming or test stimulation is complete.


General PrecautionsComponent Failures - The brain stimulationsystem may unexpectedly stop working due tothe battery wearing out or other causes. Thesymptoms you had before your system wasimplanted will likely return or worsen if thedevice stops working.Lead Materials - Over time, there is somerisk that the lead could break down. If thiswould happen, the breakdown materials areknown to cause nerve damage or cancer inanimals. The chance of these effectsoccurring in patients who receive the deviceare not yet known.Long-Term Safety and Effectiveness - Thelong-term safety and effectiveness of brainstimulation therapy for obsessive compulsivedisorder has not been established.Multiple Implants - The long-term safetyassociated with leads left in place without use,replacement of leads, multiple implants intothe target structure, and lead explant isunknown.

40 I 2 DESCRIPTIVE INFORMATION

Pushing or Twisting the Implanted Parts ofYour System - Avoid pushing or twisting theimplanted parts of your system, such as theneurostimulator. This can damage the systemor cause skin erosion. This may requiresurgery.Rebound Effect - If your brain stimulationsystem ceases to function for any reason (eg,battery depletion or exposure to EMI sourcesthat will shut off the system), your symptomswill probably return. In some cases, symptomsmay return with an intensity greater than wasexperienced prior to the system implant(rebound effect). If this occurs, contact yourphysician immediately so the status of yoursystem can be assessed and your conditioncan be closely monitored.Use in Specific Populations - The safetyand probable benefit of this therapy is notknown for:i Patients with Tourette's syndromei Patients with OCD with a primary

subclassification of hoarding


* Patients whose diagnosis of OCD isdocumented to be less than 5 yearsduration

* Patients whose YBOCS score is less than30

* Patients who have not completed aminimum of 3 adequate trials of first and/orsecond line medications withaugmentation

* Patients who have not attempted tocomplete an adequate trial of cognitivebehavior therapy (CBT)

* Patients with a previous surgical ablationprocedure (e.g., capsulotomy)

* Patients who are pregnant

* Patients under the age of 18 years· Patients with dementia* Patients with coagulopathies or who are on

anticoagulant therapy* Patients without cormorbid depression and

anxiety* Patients with neurological disorders


64

*Patients with other serious medical illnessincluding cardiovascular disease, renal orhepatic failure, and diabetes mellitus

Use in Patients with Comorbid PsychiatricDisorders - There are potential risks withimplanting the brain stimulation system inOCD patients who have comorbid psychiatricdisorders that include:* bipolar disorder* body dysmorphic disorder* expanded personality impulse-control

disorders or paraphilias* psychotic disorder* severe personality disorders* substance abuse* the inability to control suicidal impulses or

a history of suicidal attemptsThe brain stimulation system may aggravatethe symptoms of comorbid psychiatricdisorders.

2 DESCRIPTIVE INFORMATION [ 43

Electromagnetic Interference(EMI)Electromagnetic Interference is a field ofenergy (electrical, magnetic, or both) made byequipment found in the home, work, medicalor public environments that is strong enoughto interfere with your neurostimulator.Electromagnetic Interference could cause:* Serious Injury or Death, resulting from

heating of the implanted systemcomponents, which can damagesurrounding tissue. See "When the DeviceShould Not be Used (Contraindications)"on page 25 and "About ElectromagneticInterference (EMI)" on page 67.

* System Damage, requiring surgicalreplacement; or result in a loss of, orchange in, symptom control.


* Changes in Your NeurostimulatorFunction, causing it to switch ON or OFF',or reset to factory settings which mayresult in loss of stimulation, return ofsymptoms, and require reprogramming byyour doctor.

* Unexpected Changes in Stimulation,causing a momentary increase instimulation or intermittent stimulation,which some patients have described as"shocking" or "jolting."

If you think that equipment is interfering withyour neurostimulator function, you should dothe following:1. Move away from the equipment or object.

.With all neurostimulators referenced in thismanual, unexpected On/Off switching of thedevices may occur when they are exposed tomagnets and strong electromagnetic fields.With the Kinetra Model 7428, however, yourphysician may choose to disable the magnetcontrol circuit to avoid unexpected switching.If the magnet control circuit is disabled, youmay receive a therapy controller to turn yourtherapy On or Off,

2 DESCRIPTIVE INFORMATION { 45

G,

2. If possible, turn off the equipment orobject causing interference.

3. If necessary, use the control magnet ortherapy controller to return yourneurostimulator to the desired on or offstate.

4. Inform the equipment owner/operator ofwhat happened.

If the above actions do not correct the effectsof the interference, or if you think that yourtherapy is not effective after exposure to EMVI,you should contact your doctor.Refer to "Electromagnetic Interference" onpage 67, for information on sources ofElectromagnetic Interference and their effecton you and your brain stimulation system.

Living with Your Reclaim DBSTherapy: What You ShouldKnowThe following guidelines about your brainstimulation system will help to ensure that youreceive the safest and most effectivetreatment.


* Always tell any medical personnel thatyou have an implanted brainstimulation system and tell them whereit is located. If they have any questions,they should contact Medtronic at1-800-510-6735.

* If you experience any unusual symptomsthat you think may be related to yourneurostimulator, contact your doctor.

* If you have a family member or caregiver,ask them to read this manual along withyou. There may be situations where youneed their assistance.

* Go to all follow-up appointments. This willensure that you get the best care.

* When the neurostimulator is turned off,your symptoms will probably return. Somesymptoms return quickly. Other symptomsmay take longer to return.

When to Call Your DoctorCall your doctor if any of the followingsituations occur:


* You experience pain, redness, or swellingalong the scalp, neck, or chest where thestimulation system is implanted.

· You are not receiving relief from yoursymptoms and it appears that theneurostimulator is turned on.

* You feel uncomfortable or painfulsensations during stimulation. First, turnoff the neurostimulator, then call yourdoctor.

* You cannot turn on or turn off theneurostimulator.

* You experience unexpected changes inyour symptoms.

- You experience side effects such asinappropriate euphoria or disinhibition.

* You experience any unusual symptomsthat you think may be caused byelectromagnetic interference (e.g., theftdetectors).

* You lose your control magnet or therapycontroller.

48 ] 2 DESCRIPTIVE INFORMATION

Recovering at HomeAfter your surgery, your doctor or nurse willgive you instructions about care at home.These instructions often include informationabout the healing process after surgery,medication to take, and when to return to yourdaily activities.

HealingIt takes several weeks to heal from surgery.You will feel some discomfort from the incisionsites. You will feel some discomfort or pain atthe neurostimulator sites during the healingprocess. If you notice unusual symptoms,contact your doctor.

MedicationAlways follow your doctor's instructions fortaking medication.

Daily Activities and ExerciseDuring your recovery, follow your doctor'sinstructions. On the advice of your doctor, youshould be able to return to your normallifestyle after a period of healing.


Returning to your daily activities should makeyou feel better, not worse. Ask your doctorabout activities that include bending of yourneck, raising your arms over your shoulders,or strenuous activities like lifting heavyobjects.Use care when you choose any activities thatmay result in accidents or falls. Sudden jerkymovements may cause the lead(s) to move.Falls may damage parts of the implantedsystem. Surgery may be needed to repair orreplace the brain stimulation system parts.

50 I2 DESCRIPTIVE INFORMATION

3 OPERATING INFORMATION

Control DevicesYour neurostimulator can be turned on or offusing either a control magnet or a therapycontroller. Your physician will determine whichcontrol device is appropriate for your needs.You will receive a booklet that tells you how tocare for your control device.

For Soletra NeurostimulatorThe control devices for the Soletra Model7426 Neurostimulator are the Model 7452Control Magnet and the Access Review Model7438 Therapy Controller.

For Kinetra NeurostimulatorThe control devices for the Kinetra Model7428 Neurostimulator are the Model 7452Control Magnet and the Access Model 7436Therapy Controller.

Using Your Therapy ControllerIf you have a therapy controller2, refer to theuser manual supplied with the controller forspecific applications and procedures.

3 OPERATING INFORMATION 51

2$

Using Your Control MagnetA control magnet2 is used to turn yourneurostimulator on and off. When the therapyis turned on, you may experience a change inyour QOCD symptoms. Depending on yourindividual circumstance, you may have asensory experience (tingling, smell, or taste),feel a slight muscle contraction, or experienceno change at all.There may be a slight possibility of a "jolting"or "shocking" sensation when the therapy isturned on.

2. With all neurostimulators referenced in thismanual, unexpected On/Off switching of thedevices may occur when they are exposed tomagnets and strong electromagnetic fields.With the Kinetra Model 7428, however, yourphysician may choose to disable the magnetcontrol circuit to avoid unexpected switching.If the magnet control circuit is disabled, youmay receive a therapy controller to turn yourtherapy On or Off.

52 3 OPERATING INFORMATION

Turning Your Neurostimulator Onor Off with Your MagnetTo start (and stop) therapy, you will place yourcontrol magnet over your neurostimulator for 1to 2 seconds (Figure 3.2). Your doctor ornurse will show you how to position themagnet over your neurostimulator. Use thecontrol magnet as explained to you by yourdoctor or nurse. Instructions are also given onthe next few pages.Before using your control magnet, read theentire procedure below and examinefigures 3.1-3.4 on the following pages.Note: Family members or caregivers shouldbe able to turn the neurostimulator on and offusing the magnet.

3 OPERATING INFORMATION I 53

1. Grasp the magnet with the flat end awayfrom you using either your right or lefthand (Figure 3.1).

Point arrows atneurostimulator

Left-hand operaton ght-handed operation

Surface to becentered overneurostimulator

Figure 3.1 Grasp magnet with flat endaway from you.

54 1 3 OPERATING INFORMATION

2. Press the flat end of the magnet directlyover the length of your neurostimulator(Figure 3.2). Position the magnet so thatthe arrows are toward your body(Figure 3.3).

Magnet target

neurostimulator

Figure 3.2 Magnet centered over neurostimulator.


-- - - - -- Point arrow on-~magnet at

4$ /r-..%~ ineurostimulator

I, I&...

Figure 3.3 Position magnet over neurostimulatorand hold in position for 1 to 2 seconds.

3. Hold the magnet steady in place for 1 to 2seconds and then remove it. Nothinghappens if you hold the magnet in placelonger because the magnet turns yourneurostimulator on or off only as youmove it away from your body.

Note: If you have trouble turning yourneurostimulator on or off, try changing theposition of the magnet. Picture yourneurostimulator as the face of a clock. Thenplace the magnet in the one o'clock positionas shown in Figure 3.4. If the one o'clockposition does not work try the four o'clockposition.

56 a 3 OPERATING INFORMATION

'ok

One o'clock position Four o'clock position

Figure 3.4 You may need to position the magnetat the one o'clock or four o'clock position.

If you have tried repositioning the magnet, butyour symptoms do not decrease at the timethey normally do, contact your doctor.


Carrying Your MagnetYour control magnet is a very strong magnet.Cautions:* When carrying your control magnet in a

pocket or purse, make sure the magnet ison the other side of your body from wherethe neurostimulator is placed. The controlmagnet may come close enough to theneurostimulator to turn your therapy onand off when you don't expect it.

* Keep your control magnet away fromchildren.

Storing Your MagnetThe magnetic field of the control magnet canaffect other items such as watches, creditcards, and computer disks. These items canbe easily protected by keeping the controlmagnet away from them, as described below:Keep more than 2 inches away. Store thecontrol magnet more than 2 inches away froma wristwatch, pocket watch, and clock. Thecontrol magnet can stop them from working.

58 [ 3 OPERATING INFORMATION

Keep more than 6 inches away. Themagnetic field of the control magnet maydamage the information on some magneticitems. To prevent damage, keep the magnetmore than 6 inches away from the followingitems:* Items with a magnetic strip such as bank

cards and credit cards.* Magnetic media such as video and audio

cassette tapes and computer disks.* Home electric items such as personal

computers, VCRs, televisions, or cameras.


Expected Battery LifeWhen you visit the clinic or doctor, the energylevel of the battery in your neurostimulator willbe checked. The length of time the battery willlast depends on your programmed settingsand the amount of time you use yourneurostimulator.Based on the initial clinical data your batteryshould last 6 months to 16 months. However,your battery may last longer depending on theneurostimulator setting used. Your doctor cangive you an estimate based on your therapysettings.As the energy in the battery is reduced, theneurostimulator will eventually stopfunctioning and therapy will not be effectiveand will not resume until the battery isreplaced. This is normal. If you feel this kind ofchange, ask your doctor to check the battery.No surgery is required for your doctor to checkyour battery.The battery is a permanent part of theneurostimulator. To replace the battery, yourdoctor must replace the neurostimulator. Thisis a minor surgical procedure typically done

60 I 3 OPERATING INFORMATION

using a local anesthetic. It does not requirethe use of a head frame. As with the initialimplant, replacement of your neurostimulatorwill lead to surgical risks, including pain ordiscomfort at the surgical site, risk of infection,and internal or external bleeding orhemorrhage at or near the implant location.

Choosing to Turn Off or Explantthe Reclaim DBS SystemIf you and your doctor decide that theneurostimulation system does not provide thetherapy you need, it may be turned off orexplanted. If it is turned off, it will remainimplanted without stimulation. If it isexplanted, you will require surgery.

Instructions on Disposing ofYour DeviceIf your implanted system is ever explanted,your physician will dispose of your device foryou.The neurostimulator must be removed beforea body is cremated. The cremation processcan cause the battery to explode.


Your Patient Identification CardA patient identification card (Figure 3.5)identifies you as having an implanted medicaldevice. This card also provides basicinformation about your neurostimulator andlists your doctor's name and telephonenumber. The information is important forothers to know, should you need to bypass asecurity system, or in case of a medicalemergency. Keep this card with you at alltimes.You will receive a temporary card during yourhospital stay. Several weeks after your surgeryyou will receive a plastic-coated card.

62 I 3 OPERATING INFORMATION

*MudbukcMedical Device Temporary IdentificationThe bearer of this card has an issptanted medical device

prascnbed by his or her doctor.

Patient's Name

Address

City State or Ccurtry_

Phone.

In case of an emergency, please notify:

Physician

Phone ( ) _________________

Model Number_

Seriat Numberb

Implant Date

Medtonic Neuretogicat. Minneapolis MN 55421Tetephone (763) 514-5000 U S T.lt-Free: (800) 510-6735Internet: wvrwwmedtronic~com ccceEre2,q

Figure 3.5 Patient Identification Card.


If you change your address or doctor'sinformation, contact Medtronic. Include thecurrent information and indicate the changes.You may either call 1-800-510-6735 with theinformation or send the information to:Medtronic NeuromodulationDevice RegistrationPO. Box 59262710 Medtronic ParkwayMinneapolis, MN 55459-9896

64 3 OPERATING INFORMATION

4 TROUBLESHOOTING

Note: If your problem is not solved afterseveral attempts, or if your problem is notdescribed here, contact your doctor.What should I do if I have trouble turningon my Reclaim DBS Therapy or if I can't tellif it's turned on?Your doctor can advise you as to how long ittakes to feel the effects of the therapy Thistime can be different from patient to patient. Italso depends upon your medical condition.If you have a control magnet, be sure to hold itdirectly over the neurostimulator whenattempting to turn on the therapy. Also, tryrotating the magnet to the one o'clock or fouro'clock position (refer to Figure 3.1 onpage 54).If you have a therapy controller, use it to checkthe neurostimulator on or off status (refer tothe user manual supplied with your therapycontroller for specific instructions).If for some reason you cannot turn on yourtherapy, call your doctor.

4 TROUBLESHOOTING 1 65

qqi

What should I do if I think that myneurostimulator has turned offaccidentally?Turn your neurostimulator back on using yourcontrol magnet or therapy controller. If this ishappening often, review the section "AboutElectromagnetic Interference (EMI)" onpage 67 and try to identify the source of theproblem.

66 4 TROUBLESHOOTING

loo

5 ELECTROMAGNETICINTERFERENCE3

About ElectromagneticInterference (EMI)Electromagnetic interference is a field(electrical, magnetic, or a combination of both)that is generated by various equipment foundin medical, work, and home environments.This equipment can create enoughinterference to do the following;* Turn your neurostimulator off or on• Cause stimulation that can result in an

uncomfortable sensation

3.'With all neurostimulators referenced in thismanual, unexpected On/Off switching of thedevices may occur when they are exposed tomagnets and strong electromagnetic fields.With the Kinetra Model 7428, however, yourphysician may choose to disable the magnetcontrol circuit to avoid unexpected switching.If the magnet control circuit is disabled, youmay receive a therapy controller to turn yourtherapy On or Off.

5 ELECTROMAGNETIC INTERFERENCE J 67

1o)

* Reset your neurostimulator to factorysettings, which will require reprogrammingby your doctor

Your neurostimulator is designed to protectagainst most EMVI. However, strongelectromagnetic fields and permanentmagnets can interfere with your system.Specific warnings regarding possible effectsfrom EMVI are provided in the section"Electromagnetic Interference (EMVI)" onpage 44.Even when the therapy is turned off,interference can affect the lead(s). If yoususpect EMVI, move away from the source ofthe EMVI. If possible, turn off the suspectedsource of EMVI. Then use your control magnetor therapy controller to turn your therapy on oroff.Theft Detectors and SecurityGatesCaution: Walking through some theftdetectors or security gates can cause anincrease in stimulation or additional

68 I 5 ELECTROMAGNETIC INTERFERENCE

stimulation. It could also turn on or turn offyour neurostimulator.

Use care when approaching security archesor gates (such as those found in airports,libraries, and some department stores). If anairport security wand is used, ask the securitypersonnel to avoid placing the wand over yourneurostimulator.When approaching these devices, do thefollowing:1. If security personnel are present, show

them your neurostimulator identificationcard and request a hand search.

2. If you must pass through the securitydevice, approach the center of the deviceand walk normally (Figure 5.1).a. If two security gates are present, walk

through the middle, keeping as faraway as possible from each gate.

b. If one gate is present, walk as far awayas possible from it.

Note: Some theft detectors may not be visible.3. Proceed through the security arch or gate.

Do not touch, lean on, or linger near thesecurity arch or gate.

5 ELECTROMAGNETIC INTERFERENCE 69

Walking path Walking path forfor double single security gatesecurity gate (Stay as far away as

possible from gate)

Figure 5.1 Walking through security gates.

4. If you suspect that your neurostimulatorwas turned off, make sure someone isable to turn on your system again. (Theperson could be you, if your medicalcondition allows it. Or, it could besomeone who has been taught how touse the system.)

70 1 5 ELECTROMAGNETIC INTERFERENCE

Home and Work EnvironmentsMost home appliances and office equipmentwill not affect your therapy, if they are installedproperly and in good working order.

Interference Likely - Home andWork EnvironmentAvoid the following equipment orenvironments. EMI from the following mayaffect or damage the neurostimulator.i Antenna of a citizen band or ham radio

* Electric arc or resistance weldingequipment

i Electric induction heaters used in industryto bend plastic

* Electric steel furnaces, for example, theblast furnaces found in steel mills, not thefurnaces found in your home

* Power lines* Television and radio transmitting towers* Electric substations and power generators


· Therapeutic magnets, if placed close toneurostimulator

Possible Interference - Home andWork EnvironmentSome household items have small, strongmagnets. You can use these items if you keepa distance that is expected for normal use ofthe item. Some examples are describedbelow. If you notice that your therapy isaffected by being too near to an item, moveaway from it. If EMI has started or stoppedyour therapy, use the control magnet ortherapy controller to return your therapy to itsoriginal state.i You can open and shut a refrigerator or

freezer door. However, do not leanagainst the magnetic strip inside arefrigerator or freezer door.

* You can listen with a standard, cordlessor cellular telephone handset, but do notpass or lay the earpiece over theneurostimulator because you may turn iton or off.


· You can be near stereo speakers andradios for the home or the car. However,do not lift or carry them so that they areclose to or touching the part of your bodywhere the neurostimulator is located.

* You can use a sewing machine or salonhair dryer. However, keep yourneurostimulator away from the motors(such as when leaning over these items).

* You can use an induction range (orsmooth top range). Keep yourneurostimulator away from the burners.

* You can use power tools when the motoris kept away from the neurostimulator. Donot lean against the tool. Use cautionwhen using power tools that may beunsafe if your symptoms would return.

Safe from Interference - Homeand Work EnvironmentThe following items should not interfere withyour neurostimulator when they are properlyinstalled and in good working order:* Microwave ovens


· Appliances like washing machines, dryers,electric stoves, toasters, blenders, electriccan openers, and food processors

* Electric blankets and heating pads* Hand-held items like hair dryers, shavers,

remote controls, and pagers* Home security systems* Personal computers, electric typewriters,

copiers, and fax machines* Televisions, AM and FM radios, and

stereos* Vacuum cleaners and electric brooms

Medical and DentalEnvironmentsTell medical and dental personnel that youhave a neurostimulation system that workssimilar to a pacemaker. (Both systemscreate amounts of electricity.)Most routine diagnostic procedures, such asfluoroscopy and x-ray, do not affect thesystem. And, some procedures can be donewhen precautions are taken. However,

74 5 $ ELECTROMAGNETIC INTERFERENCE

interference from some medical procedurescan:* Damage a component of your system

requiring surgery to replace it; or* Affect your brain stimulation system, for

example, turning your neurostimulator onor off; or

* Cause harm to you, for example, heating asystem component enough that it cancause tissue damage.

Interference Likely - Medical andDental EnvironmentThe following procedures can damage theneurostimulator or cause harm to you.Avoid the following procedures:* Diathermy (deep heat treatment)* MRI (magnetic resonance imaging)* TMS (transcranial magnetic stimulation)Note: Additional safety information aboutdiathermy, MRI, and TMS is located in thefront of this manual. Refer to "When the

5 ELECTROMAGNETIC INTERFERENCE I 75

/oci

Device Should Not be Used(Contraindications)" on page 25.If any of the procedures listed below arerequired, please inform your treating doctorthat you have an implanted neurostimulator.Your doctor should contact Medtronic at1-800-510-6735 for more information:* Somatic psychiatric therapies. The

safety of somatic psychiatric therapiesusing equipment that generateselectromagnetic interference (eg, vagusnerve stimulation) has not beenestablished.

* Cautery or Electrocautery (stops thebleeding of blood vessels. It is used duringmost surgeries.)

* External defibrillation (strong electricalshock that slows a fast heartbeat)

* Lithotripsy (the crushing of stones usingelectricity. These stones are usually in thegallbladder or urinary tract.)

* Radiation therapy (often used in cancertreatment). This may be done if the focus

76 5 ELECTROMAGNETIC INTERFERENCE

of the therapy is away from theneurostimulator.

Possible Interference - Medicaland Dental EnvironmentThe following procedures can be done whenthe therapy is turned off and when the medicalequipment is not directly over yourneurostimulator. If the equipment is placedover your neurostimulator, it may be turned onaccidently, or it can be permanently damaged,which will require surgery.* Dental drills and ultrasonic probes

(used to clean teeth)* Electrolysis (removes unwanted hair)Note: Additional safety information abouttherapeutic ultrasound is located in the front ofthis manual. Refer to "When the DeviceShould Not be Used (Contraindications)" onpage 25.The following procedures and devices requiresafeguards:* Implantable device that senses

electrical signals such as a pacemakeror defibrillator (medical device placed

5 ELECTROMAGNETIC INTERFERENCE I 77

\It

inside the body to regulate the heart rate).Tell the cardiac doctor that you have aneurostimulator.

* Mammography (x-ray of breast tissue).When an x-ray requires tight pressurearound the neurostimulator, such as duringmammography, tell the person using theequipment that the brain stimulationsystem should not be squeezed tightly. Toomuch pressure can permanently damagethe system, which will require replacementsurgery.

78 5 ELECTROMAGNETIC INTERFERENCE

Safe from Interference - Medicaland Dental EnvironmentThe following medical procedures should notaffect your therapy:* Computerized axial tomography (CT or

CAT) scans. (A special type of x-rayequipment that gives a cross-section view.)

* Diagnostic ultrasound. (An imagingtechnique which uses high-frequencysound waves.)

· Diagnostic x-rays. Diagnostic x-rays donot interfere With the system. However,tight pressure can affect the system, asdescribed above in Mammography.



6 COMMON QUESTIONS

About the System and itsComponentsWill the neurostimulator show through myclothes?Depending on your body build, theneurostimulator may be noticeable as a smallbulge under the skin. However, your doctor willtry to place the neurostimulator in a place thatis most comfortable and cosmeticallyacceptable.What does stimulation feel like?You may not feel stimulation. You willexperience the effects of stimulation when itreduces the symptoms of your medicalcondition. Some people may feel a brieftingling sensation when the therapy is firstturned on. Higher levels of stimulation havebeen described as uncomfortable, "jolting" or"shocking" by some patients.Does the brain stimulation system makeany noise?No.

6 COMMON QUESTIONS I 81

Turning On and Turning OffReclaim DBS TherapyWhat happens if the neurostimulator stopsworking?Your symptoms will probably return and maybe worse than prior to the beginning ofstimulation therapy. If you can't determine thepossible cause and correct the problem,contact your doctor.Will I be able to increase or decrease thestrength of stimulation?In many cases, the strength of stimulation canonly be changed by your doctor. Somepatients with an implanted Kinetraneurostimulator can change stimulationsettings by using a therapy controller. If youhave an implanted Kinetra neurostimulator,consult with your doctor to determine if youcan increase or decrease the strength ofstimulation.

Everyday Use of Your TherapyWill I be able to resume my normal dailyactivities?

82 I 6 COMMON QUESTIONS

For the first few weeks after surgery, youshould avoid strenuous activity, armmovements over your shoulder, and excessivestretching of your neck. You may graduallywant to try activities that were difficult beforeyour surgery. Talk about this with your doctorfirst.Can stimulation be used duringpregnancy?The safety of using Reclaim DBS Therapyduring pregnancy or delivery is not known. Ifyou learn, or think, that you are pregnant, callyour doctor immediately.What should I do if the stimulationchanges or becomes uncomfortable?Contact your doctor immediately.

6 COMMON QUESTIONS 1 83

84 I 6 COMMON QUESTIONS

I';,

7 QUICK LOOK-UP TABLE FORINTERFERENCE FROMEQUIPMENT

Equipment in your daily environment couldaffect your system. Ways to minimize orprevent interference from happening, isdiscussed in the chapter 'Troubleshooting"beginning on page 65. To help you quicklylocate information about an item, use thistable to find the page number containingdetails.

7 QUICK LOOK-UP TABLE FOR INTERFERENCE 85

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8 ADDITIONAL INFORMATION

More About Reclaim DBSTherapyFor additional information about Reclaim DBSTherapy, use these resources:* Medtronic web site: www.medtronic.com* Contact Medtronic Patient Services

1-800-510-6735' Contact your doctor

8 ADDITIONAL INFORMATION 1 93

94 I 8 ADDITIONAL INFORMATION

INDEX

AActivities, daily 49Address change, contacting Medtronic 64After surgery 36, 82Appliances

interference from 72safe items 73

BBattery

extending length of use 60how long it will last 60replacement 60

Benefits and limitations of Reclaim DBSTherapy for OCD 31

Brain stimulationcommon questions about 81correcting interference 45increase in stimulation 45interference 45intermittent stimulation 45living with brain stimulation 46

INDEX 95

possible side effects 28precautions 40sensations from 81warnings 38

Brain stimulation systemcontraindications 25damage from EMI 44how it works 24parts of implanted system 19picture of implanted system 22, 23possible device complications 30risks of implantation 27when it should not be used 25

CCalling the doctor 47, 76Card, patient identification 62Caregivers, information for 3Changes in stimulation 45Changing your address 64Common questions about brain stimulation 81Contraindications

diathermy 25for Reclaim System 25MRI 26

96 J INDEX

TMS 26Control magnet

adjusting the neurostimulator 46, 52carrying the magnet 58keeping away from magnetic fields 58procedure for using 53storing the magnet 58

Cremation 61

DDaily activities 82Dental equipment, interference from 74Description

brain stimulation system 19Reclaim DBS Therapy 17Reclaim System 19

Diathermycontraindication for brain stimulation 25should not be used 25, 75

INDEX 97

Disposal of neurostimulator 61Doctor, when to call 47

EEffects of EMI on stimulation 67, 74Electromagnetic Interference (EMI). See EMIEMI

about 67changes to On and Off neurostimulator

function 45correcting interference 45, 68damage to brain stimulation system 44dental equipment sources 74description 67effects on brain stimulation 67, 74heating of implanted components 44medical equipment sources 74moving away from the source 68precautions 44safe appliances and equipment 73safe medical and dental procedures 79security gates 68sources at home 71sources at work 71sources likely to cause interference 71, 75

98 INDEX

sources that may cause interference 72, 77stimulation changes 45theft detectors 68

Excessive stimulation 38Exercise 49Extension

description 20implant location 20picture of 19

GGlossary 11

HHospital stay after implant 34Household appliances, interference from 72

IInterference with brain stimulation 45Interference, electromagnetic. See EMI

LLead

description 19

INDEX 99

implant location 19picture of 19placement in the brain 33, 34, 35

Living with brain stimulation 46

MMagnet. See Control magnetMagnetic Resonance Imaging (MRI). See MRIMedical equipment, interference from 74Medical personnel

informing of implant 3, 74when to call 47

Medication 49Medtronic phone number

for Patient Services 3, 93for physicians 3

Medtronic web site 93MRI

contraindication 26when not to use 26

NNeurostimulator

description 20disposal if removed 61

100 INDEX

implant location 20picture of 19programming 36turning Off 53turning On 53, 66

PPatient identification card 62Precautions 40Pregnancy 83Programming the neurostimulator 36

0Questions about stimulation 81

RReclaim DBS Therapy

changes in therapy 36contraindications 25description 17precautions 40risks 27turning On and Off 82warnings 38

INDEX [101

when it should not be used 25Reclaim DBS Therapy for OCD

benefits and limitations of 31Reclaim System

description 19picture of implanted system 22, 23

Replacing the battery 60Risks

of implant surgery 27of implanting brain stimulation system 27possible complications with the system

parts 30possible side effects of brain stimulation 28

SSafe medical and dental procedures 79Security gates

effect on stimulation 68procedure for approaching 68

Side effects of brain stimulation 28Stimulation

correcting interference 45increase in stimulation 45interference 45intermittent 45

1021 INDEX

living with Reclaim Therapy 46possible side effects 28questions about 81sensations from 81

Stimulation target 35Storing the control magnet 58Surgery

after the procedure 36anticoagulant medication 38before the procedure 32day of procedure 33lead placement 33length of hospital stay 34medication 32resuming daily activities 82risks 27surgical steps 33test stimulation at implant 34

Symptomschanges in level of suppression 36

TTheft detectors

effect on stimulation 68procedure for approaching 68

INDEX 103

Therapychanges in 36precautions 40warnings 38

Tingling 81Troubleshooting stimulation problems 65Turning therapy On and Off 53, 65, 82

WWarnings 38

anticoagulant medication 38excessive stimulation 38

Web site for Medtronic 93

104 INDEX

INDEX 1105

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106 INDEX

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Medtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432-5604USAInternet:www.medtronic.comTel. 1-763-505-5000Toll-free 1-800-328-0810Fax 1-763-505-1000

© Medtronic, Inc. 2009All Rights Reserved

*NA10554A002 MA10554AG02

L41

Documents

PATIENT LABELING · area of your brain that may alter the way you feel. Electromagnetic Interference (EMI) - Electrical or magnetic energy that is strong enough to interfere with