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Form MEDN-0500 version 3.0 NEUROMODULATION CONFIDENTIAL DOCUMENT/RECORD This document/record is electronically controlled, printed copies are considered uncontrolled. Identifier Version Author Title: Pages: (including this page) APPROVALS Signed By Responsibility Date/Time (GMT) NDHF1245-121586 4.0 Monica Tuy97745 User Manual DRAFT for Agency and Summative TestingMonica Tuy Technical Communications Approver 7/12/2012 5:42:48 PM257

CONTROLLER97745Pain therapy user manual for Intellis™ Model97715 and Model 97725 Wireless ExternalNeurostimulation Systems! USA Rx only2013Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-04

Medtronic®, AdaptiveStim®, and SoftStart/Stop® aretrademarks of Medtronic, Inc., registered in the U.S. andother countries.Intellis™ is a trademark of Medtronic, Inc.! USA FCC InformationThe following is communications regulation informationon the Model 97745 Controller.FCC ID: LF597745This device complies with Part 15 Rules. Operation issubject to the following two conditions: (1) this devicemay not cause harmful interference and (2) this devicemust accept any interference received, includinginterference that may cause undesired operation.IMPORTANT: Changes or modifications to thisproduct not authorized by Medtronic, Inc., couldvoid the FCC Certification and negate your authorityto operate this product.This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to thefollowing two conditions: (1) this device may not causeinterference, and (2) this device must accept anyinterference, including interference that may causeundesired operation of the device.Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-04

Label SymbolsExplanation of symbols on products andpackaging. Refer to the appropriate product tosee symbols that apply.Conformité Européenne (EuropeanConformity). This symbol means that thedevice fully complies with AIMD Directive90/385/EEC (NB 0123) and R&TTEDirective 1999/5/EC.Consult instructions for useMR Magnetic Resonance (MR) UnsafeManufacturerSerial numberPIN No. PIN numberEC REPAuthorized representative in the Europeancommunity+XXX °F+XX °C-XX °F-XX °C Temperature limitationNon-ionizing electromagnetic radiationIEC 60601-1/EN60601-1, Type BFEquipment97745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-043Label Symbols

Table of contentsLabel Symbols 3Glossary 121 Introduction 20How to use this manual 20Patient guides 22Patient identification card 252 Important therapyinformation 28Purpose of the device 28Purpose of the neurostimulation system(indications) 28Description of your system 29Therapies that may not be used with theneurostimulation system(contraindications) 33Risks and benefits 33Risks of surgery 34Warnings 34Precautions 4397745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-045Table of contents

Individualization of Treatment 483 Recovery and care aftersurgery 52Recovery from surgery 52Activities 52When to call your clinician 54Care schedule 554 Using your controller 58How your controller works 58Controller screen and keys 59Home screen 62Unlocking and locking yourcontroller 65Unlocking your controller 65Locking your controller 69Turning your stimulation on or off 70Turning your stimulation on for all painareas 70Turning your stimulation off for all painareas 72How to maintain neurostimulatorbatteries 75English 97745Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-046Table of contents

Checking the battery status of the controllerand neurostimulator 75Changing controller preferences using theMenu 80To access the Menu screen 80Changing the audio and vibrationsettings 84Changing the brightness of the controllerdisplay 86Changing the date 87Changing the time 88Changing the language 90Changing the number format 91Viewing information about the controllerand the neurostimulator 925 Adjusting your stimulation 96Introduction 96Stimulation features 96Adjusting stimulation settings 96Programming modes 100Changing parameter and stimulationsettings 101Increasing or decreasing a parameter(intensity, pulse width, or rate) 10697745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-047Table of contents

Adjusting intensity for all pain areastogether 108Turning stimulation on or off for individualpain areas 110Turning cycling on or off 112Changing a program for individual painareas 114Viewing and changing a group 115Using AdaptiveStim 117AdaptiveStim groups and positions 119Checking your body position 121Turning AdaptiveStim on or off 124Making adjustments to AdaptiveStim 1256 MRI examinations 128If you have an MRI appointment 128Responsibilities of the patient in preparingfor the MRI appointment 129At the MRI appointment 130Determining if you are in MRI mode 131Placing your neurostimulation system inMRI mode for the MRI scan 133Using your controller to activate MRImode 134Activating MRI mode 135English 97745Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-048Table of contents

Turning stimulation back on after the MRIscan 139Visiting your clinician to activate MRImode 1417 Using the recharging system withthe implantedneurostimulator 146Recharging the implanted neurostimulatorbattery 146Recharging the neurostimulatorbattery 146To stop recharging the neurostimulatorbattery 154Changing the recharging temperature andspeed 155Recharging the controller batterypack 1588 Troubleshooting 164Controller screens 164Warning screens 165Alert screens 173Notification screens 18297745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-049Table of contents

Possible problems and solutions 1879 Additional information 194How stimulation works 194Controlling your stimulation 199What your clinician controls 199What you control 199Possible adverse effects 200Changes in therapy 200Possible system complications 20010 Maintenance andassistance 204Accessories 204Labeling the controller 204Using the carrying case 205Replacing the type AA controllerbatteries 206Replacing the controller battery pack 207Setting up a new controller 208Cleaning and care 219Safety and technical checks 221Battery and controller disposal 221Neurostimulator disposal 221English 97745Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0410Table of contents

Specifications 222User assistance 223Declaration of conformity 22411 Appendix A: Electromagneticinterference (EMI) 226Contraindication 226Warnings 227Precautions 238Notes 242Index 24497745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0411Table of contents

GlossaryCaution - A statement describing actions thatcould result in damage to or improperfunctioning of a device.Clinician - A healthcare professional such asa doctor or nurse.Clinician programmer - A device used by aclinician to send instructions to aneurostimulator.Contraindication - A condition orcircumstance when a person should nothave a neurostimulation system.Controller - A hand-held device that allowsyou to turn your neurostimulator on and offand check your neurostimulator battery. It isalso used to adjust some of the stimulationsettings.English 97745 2013-04Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0412Glossary

Diathermy - A medical treatment applied tothe outside of the body that delivers energyinto the body. Three types of energy that canbe used are shortwave, microwave, andultrasound. Depending on the power levelused, diathermy devices may or may notproduce heat within the body. Thistreatment is typically used to relieve pain,stiffness and muscle spasms, reduce jointcontractures, reduce swelling and pain aftersurgery, and promote wound healing.Discharged battery - The rechargeablebattery is depleted and should be chargedas soon as possible. When the battery is ina discharged state, therapy is notavailable.Elective replacement indicator (ERI) -Notification that the INS is nearing or hasreached its recommended replacementdate.Electrode - A metal piece near the tip of thelead. Electrodes deliver electrical pulses tothe area where your pain signals will beblocked.97745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0413Glossary

Electromagnetic interference (EMI) - Astrong field of energy near electrical ormagnetic devices that could prevent theneurostimulator from functioning properly.End of service (EOS) - Condition of an ENSat the time it is no longer able to operatesuccessfully.External neurostimulator (ENS) - SeeNeurostimulator.Group - Collection of programs that worktogether for a particular effect or area.Implanted neurostimulator (INS) - SeeNeurostimulator.Indication - The purpose of theneurostimulation system and the medicalcondition for which it may be implanted.Intensity - The strength of an electricalpulse.English 97745 2013-04Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0414Glossary

Neurostimulation system - The implantedand external components of the stimulationsystem that delivers electrical pulses toblock pain signals as they move to thebrain.Neurostimulator - The power source of aneurostimulation system. It contains thebattery and electronics that control thestimulation you feel. An externalneurostimulator is carried outside the body.During test stimulation, it is used todetermine whether or not stimulation iseffective. An implanted neurostimulator isplaced inside the body. If stimulation iseffective during test stimulation, theneurostimulator is implanted.Out-of-regulation (OOR) - Theneurostimulator battery is unable to producethe levels of energy required for the currentstimulation settings.Pain areas - An area of the body where apatient feels pain.97745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0415Glossary

Parameter - One of three stimulation settingsthat adjust the electrical pulse: intensity,pulse width, and rate.Precaution - See Caution.Program - Stimulation directed to a specificpain site.Pulse width - The length or duration of anelectrical pulse.Recharger - The component of theneurostimulation system that is used torecharge your neurostimulator battery.SoftStart/Stop - This feature is programmedby your clinician. When the neurostimulatoris turned on, stimulation will slowly increaseto the programmed intensity. When theneurostimulator is turned off, stimulation willslowly decrease.Spinal cord - This is your body's informationcenter. Nerve signals from the entire bodytravel to your spinal cord, and then to yourbrain.English 97745 2013-04Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0416Glossary

Stimulation - The delivery of electrical pulsesto the area where pain signals are blockedas they move to the brain. Stimulationblocks some pain signals from reaching thebrain.Stimulation settings - Refers to all thefeatures assembled to define the stimulationyou feel. The clinician programs allstimulation. You can adjust somestimulation settings within clinician-definedlimits.Test stimulation - The period of time when anexternal neurostimulator is used todetermine if stimulation blocks the painsignals effectively.Therapy - Treatment of a disease or condition.When neurostimulation therapy isprescribed, a neurostimulation system isused to deliver stimulation to one or morepain sites.97745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0417Glossary

Therapy settings - A specific combination ofintensity, rate, and pulse width parametersused to control the stimulation delivered bya neurostimulator.Warning - A statement describing an action orsituation that could harm the patient.English 97745 2013-04Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0418Glossary

1 IntroductionFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-04

How to use this manualUse this manual during test stimulation andafter receiving an implanted neurostimulator.Ask your clinician to explain anything that isunclear.•A glossary is provided at the beginning ofthis manual.•Chapter 1 "Introduction", describes how touse this manual, patient guides you shouldreceive, and information about the patientidentification card.•Chapter 2 "Important therapy information",describes when you should and should notuse a neurostimulation system, theneurostimulation system components, andthe risks, benefits, warnings, precautions,and patient activities related to yourneurostimulation system.•Chapter 3 "Recovery and care aftersurgery", provides information aboutrecovering from surgery, activity and careEnglish 97745 2013-04Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0420Introduction 1

information, and when to contact yourclinician.•Chapter 4 "Using your controller",describes the controller and how to performspecific tasks.•Chapter 5 "Adjusting your stimulation",describes how to adjust your stimulationusing your controller.•Chapter 6 "MRI examinations", providesimportant information about what youshould do if you have an MRIexamination.•Chapter 7 "Using the recharging systemwith the implanted neurostimulator",describes how to use the rechargingsystem to recharge your implantedneurostimulator battery.•Chapter 8 "Troubleshooting", describescontroller warning, alert, and informationscreens and how to solve problems.•Chapter 9 "Additional information",describes how stimulation works, possible97745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0421Introduction 1

adverse effects, changes in therapy, andpossible system complications.•Chapter 10 "Maintenance and assistance",describes how to set up a new controller,care for your controller, and instructions onusing accessories. This chapter alsoprovides controller specifications andinformation about who to call forassistance.•Chapter 11 "Appendix A: Electromagneticinterference (EMI)", provides informationabout electromagnetic interference andhow it may affect your neurostimulationsystem.Patient guidesTable 1.1 on page 23 describes thedocuments you should receive during teststimulation and after a neurostimulator isimplanted.English 97745 2013-04Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0422Introduction 1

Table 1.1 Patient guides for test stimulationand implanted neurostimulation systems Document ENSaINSbMedtronic Model97725 WirelessExternalNeurostimulator:Test StimulationPatient GuideDescribes thegoals, activities,components, andinstructions fortest stimulation.XMedtronic Model97745 Controller:Quick ReferenceGuide: Providesinstructions forcommoncontroller tasks.X X97745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0423Introduction 1

Table 1.1 Patient guides for test stimulationand implanted neurostimulation systems (continued)Document ENSaINSbMedtronic Model97755Recharger:RechargingSystem UserManual:Describes thecomponents ofthe rechargingsystem, includingthe rechargeablebattery pack andpower supply.XPatientIdentificationCard: Providesinformation aboutyou, yourimplantedneurostimulator,and your doctor.XaExternal neurostimulatorbImplanted neurostimulatorEnglish 97745 2013-04Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0424Introduction 1

Patient identification cardWhen you leave the hospital, your doctor willgive you a patient identification card. This cardsupplies information about you, your implanteddevice, and your doctor. Your identificationcard may allow you to bypass security devices.Carry this card with you at all times and bringthis card with you to all MRI appointments (seeChapter 6 "MRI examinations").If you move, change doctors, or lose your card,contact Medtronic for a replacement card.Refer to the Medtronic contacts at the end ofthis manual.! USA A temporary identification card will beprovided at the hospital. After Medtronicreceives your implant registration from thehospital, you will receive a permanentidentification card.97745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0425Introduction 1

English 97745 2013-04Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0426Introduction 1

2 ImportanttherapyinformationFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-04

Purpose of the deviceThe Medtronic Model 97745 Controller isdesigned to program the following Medtronicneurostimulators:Rechargeable•Intellis Model 97715 ImplantedNeurostimulatorNonrechargeable•Model 97725 Wireless ExternalNeurostimulatorRefer to your patient identification card todetermine the model number of yourneurostimulator.Purpose of theneurostimulation system(indications)Refer to the indications sheet that is packagedwith the controller for the purpose of theneurostimulation system and relatedinformation.English 97745 2013-04Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0428Important therapy information 2

Description of your systemA typical neurostimulation system hasimplanted parts that deliver the electricalpulses to the area where your pain signals areblocked.Typically the implanted parts of aneurostimulation system include (Figure 2.1):a neurostimulator, 1 or more leads, and 1 ormore extensions (optional).97745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0429Important therapy information 2

NeurostimulatorExtensionsLeadsElectrodesFigure 2.1 Implanted parts of a typical neurostimulation system (spinal cord stimulation shown).A typical neurostimulation system alsoincludes an external controller for controllingyour system. If you have a rechargeableneurostimulator, your system also includes arecharging system (Figure 2.2).English 97745 2013-04Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0430Important therapy information 2

BeltBattery packPower SupplyRechargerRecharging system(packaged separately)Controller Figure 2.2 Recharging components of a rechargeable neurostimulation system.Neurostimulator – The neurostimulator is thepower source (battery) for yourneurostimulation system. It containselectronics that generate the electrical pulses.During test stimulation, an externalneurostimulator is used to determine whetheran implanted neurostimulator is the rightchoice for you.97745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0431Important therapy information 2

Note: Your controller refers to theneurostimulator as the device.Lead(s) – A lead is a set of thin wires, coveredwith a protective coating. A lead has smallmetal electrodes near the tip. The electrodestransmit electrical pulses to the area whereyour pain signals are blocked.Extension(s) – An extension is a set of thinwires, covered with a protective coating, thatconnects the neurostimulator to a lead. Not allneurostimulation systems include anextension.Controller – A controller is a hand-held devicethat you use to select and adjust yourstimulation. Recharging system – The recharging systemis used to charge the implanted rechargeableneurostimulator battery. Components includedin the recharging system are: recharger, belt,battery pack, power supply, and systemcarrying case. Refer to the manual packagedwith the recharging system for moreEnglish 97745 2013-04Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0432Important therapy information 2

information about the recharging systemcomponents.Therapies that may not beused with theneurostimulation system(contraindications)Diathermy—Inform anyone treating you thatyou CANNOT have any shortwave diathermy,microwave diathermy or therapeuticultrasound diathermy (all now referred to asdiathermy) anywhere on your body becauseyou have an implanted neurostimulationsystem. Energy from diathermy can betransferred through your implanted system,and can cause tissue damage, resulting insevere injury or death.Risks and benefitsStimulation has helped thousands of patientsmanage their pain and improve their quality oflife. Your neurostimulation system may beused with other pain treatments. Stimulation97745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0433Important therapy information 2

will not cure your pain. It can, however, reduceyour pain to a tolerable level and allow you toresume many of your daily activities.Risks of surgeryImplanting a neurostimulation system has riskssimilar to spinal procedures, including spinalfluid leak, headaches, swelling, bruising,bleeding, infection, or paralysis.If you are on anticoagulation therapy you mightbe at greater risk for postoperativecomplications such as hematomas that couldresult in paralysis.For information about possible adverseeffects, refer to "Possible adverse effects" onpage 200.WarningsWound contact—DO NOT use the rechargeron an unhealed wound. The recharging systemis not sterile, and contact with the wound maycause an infection.English 97745 2013-04Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0434Important therapy information 2

Trial systems (neurostimulation systemsthat are not fully implanted)—MRI should notbe prescribed for patients undergoing trial(test) stimulation or who have anyneurostimulation system components that arenot fully implanted. If an MRI scan is required,the clinician must explant all trial (test)stimulation components. MRI has not beentested on trial (test) stimulation componentsand may cause heating of the lead electrodes,resulting in tissue damage or serious patientinjury.Electromagnetic interference—Electromagnetic interference (EMI) is a field ofenergy generated by equipment found in thehome, work, medical, or public environmentsthat is strong enough to interfere withneurostimulator function. Neurostimulatorsinclude features that provide protection fromEMI. Most electrical devices and magnetsencountered in a normal day are unlikely toaffect the operation of a neurostimulator.However, sources of strong EMI can result inthe following:97745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0435Important therapy information 2

•Serious patient injury or death, resultingfrom heating of the implanted componentsof the neurostimulation system anddamage to surrounding tissue.•System damage, resulting in a loss of orchange in symptom control and requiringadditional surgery.•Operational changes to theneurostimulator, that can cause it to turnon or off, resulting in loss ofneurostimulation and the return ofunderlying symptoms.•Unexpected changes in stimulation,causing a momentary increase instimulation or intermittent stimulation,which some patients have described as ajolting or shocking sensation. Although theunexpected change in stimulation may feeluncomfortable, it does not damage thedevice or injure a patient directly. In rarecases, as a result of the unexpectedchange in stimulation, patients have fallendown and been injured.English 97745 2013-04Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0436Important therapy information 2

Refer to the following table for informationon the effect of EMI on you and yourneurostimulation system. Additionalinformation and instructions on how toreduce the risk from EMI are located inAppendix A of this manual.97745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0437Important therapy information 2

Table 2.1 Potential effects of EMI from devices or procedures Device or pro-cedureSeriouspatientinjuryDevicedamageDevice turnsoff/onMomentaryincrease instimulationIntermittentstimulationBone growthstimulatorsX X XCT scans XDefibrillation/cardioversionX X X XDental drillsand ultrasonicprobesXDiathermy,therapeuticX X XElectrocautery X XElectrolysis X XEnglish 97745 2013-04Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0438Important therapy information 2

Table 2.1 Potential effects of EMI from devices or procedures (continued)Device or pro-cedureSeriouspatientinjuryDevicedamageDevice turnsoff/onMomentaryincrease instimulationIntermittentstimulationElectromagnet-ic field devices(eg, arc weld-ing, power sta-tions)X X XHigh-output ul-trasonics / lith-otripsyXHouseholditemsX XLaser proce-duresX97745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0439Important therapy information 2

Case damage—If the neurostimulator case isruptured or pierced due to outside forces,severe burns could result from exposure to thebattery chemicals.Neurostimulator interaction with implantedcardiac devices—When a neurostimulatorand an implanted cardiac device (eg,pacemaker, defibrillator) are required, thedoctors involved with both devices (eg,neurologist, neurosurgeon, cardiologist,cardiac surgeon) should discuss the possibleinteractions between the devices beforesurgery. To minimize or prevent devicedamage or interactions, your doctors shouldplace the devices on the opposite side of thebody from one another.•Defibrillation therapy from an implanteddefibrillator can damage theneurostimulator.•The electrical pulses from theneurostimulation system could affect withthe sensing operation from the cardiacdevice and result in inappropriateresponses from the cardiac device.YourEnglish 97745 2013-04Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0442Important therapy information 2

doctor should program yourneurostimulator to a bipolar configurationand a minimum rate of 60 Hz. The cardiacdevice should be programmed to bipolarsensing.PrecautionsSystem and therapyBattery charge level—Check battery statusand charge the battery regularly. Batterycapacity will continue to slowly drain, evenwhen the neurostimulator is off. If the batterybecomes completely discharged, therapy willbe lost.Clinician programmer interaction with acochlear implant—If you have a cochlearimplant, the external portion of the cochlearsystem should be kept as far away as possiblefrom the clinician programmer or the cochlearimplant should be turned off duringprogramming to prevent unintended audibleclicks.97745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0443Important therapy information 2

Component compatibility—For propertherapy, use only Medtronic Neuromodulationcomponents that are prescribed by yourphysician.Equipment modification—Do not modify thisequipment. Modification of this equipment canresult in damage to the device, causing thedevice to malfunction or become unusable.Patient control devices may affect otherimplanted devices—Do not place patientcontrol devices (eg, patient programmer,controller, recharger) over another device (eg,pacemaker, defribrillator, anotherneurostimulator). The patient control devicecould accidently change the operation ofanother device.Patient device handling—To avoiddamaging the device, do not immerse it inliquid; do not clean it with bleach, nail polishremover, mineral oil, or similar substances;and do not drop it or mishandle it in a way thatmay damage it.English 97745 2013-04Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0444Important therapy information 2

Patient device use—When operating apatient control device (eg, externalneurostimulator, patient programmer,controller, recharging system), use specialcare near flammable or explosiveatmospheres. An interaction between theflammable or explosive atmospheres and thebattery in the device could occur. Theconsequences of using a battery-powereddevice near flammable or explosiveatmospheres are unknown.Programmer interaction with other activeimplanted devices—If you have aneurostimulator and another active implanteddevice the radio-frequency (RF) signal used toprogram either device can reset or reprogramthe other device. To verify that inadvertent programming did notoccur, clinicians familiar with each deviceshould check the programmed settings beforeyou are sent home from the hospital and aftereither device is programmed (or as soon aspossible after these times).97745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0445Important therapy information 2

$Contact your doctor immediately if you noticesymptoms that could be related to eitherdevice or to the medical condition treated byeither device.Patient activitiesActivities requiring excessive twisting orstretching—Avoid activities that may putundue stress on the implanted components ofyour neurostimulation system. Activities thatinclude sudden, excessive, or repetitivebending, twisting, bouncing, or stretching cancause parts of your neurostimulation system tofracture or migrate. This can result in loss ofstimulation, intermittent stimulation,stimulation at the fracture site, and additionalsurgery. Spinal cord stimulation patients, inparticular, should avoid excessive bending ofthe torso.Component manipulation (twiddler’ssyndrome)—Do not manipulate or rub yourneurostimulation system through the skin; thisis sometimes called “twiddler's syndrome.”Manipulation can cause damage to yourEnglish 97745 2013-04Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0446Important therapy information 2$

$system, lead dislodgement, skin erosion, orstimulation at the implant site.Scuba diving or hyperbaric chambers—Donot dive below 10 meters (33 feet) of water orenter hyperbaric chambers above 2.0atmospheres absolute (ATA). Pressuresbelow 10 meters (33 feet) of water (or above2.0 ATA) can damage the neurostimulationsystem. Before diving or using a hyperbaricchamber, discuss the effects of high pressurewith your doctor.Skydiving, skiing, or hiking in themountains—High altitudes should not affectthe neurostimulator; however, you shouldconsider the movements involved in anyplanned activity and take precaution to not putundue stress on your implanted system.During skydiving, the sudden jerking thatoccurs when the parachute opens candislodge or fracture the lead, requiringadditional surgery to repair or replace thelead.Unexpected changes in stimulation—Electromagnetic interference, changes in97745 2013-04 English Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 05-01-2012M948515A001 Rev X 2013-0447Important therapy information 2$

Medtronic 97745 97745 User Manual part 1 of 6

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