Spinal Modulation orporated MN0200 Implantable Neurostimulator User Manual LP0275 Rev B September 2011

Spinal Modulation, Incorporated Implantable Neurostimulator LP0275 Rev B September 2011

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

Axium™NeurostimulatorSystem



PhysicianImplantManual



SpinalModulation,Inc.

1135O’BrienDrive

MenloPark,CA94025

USA



Copyright©September2011bySpinalModulation,Inc.AllRightsReserved.Noportionofthismanualmaybereproducedor

transmittedinanyformorbyanymeans,electronicormechanical,includingphotocopying,recording,oranyinformation

storageandretrievalsystems,withouttheexpresswrittenpermissionofSpinalModulation,Inc.



LP0275RevB,September2011

SpinalModulation,Inc. PhysicianImplantManual

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Contents

ExplanationofSymbolsonProductorPackageLabeling................................................. 4

INTRODUCTION ............................................................................................................................ 5

SystemOverview ............................................................................................................ 6

IndicationsforUse .......................................................................................................... 7

Contraindications............................................................................................................ 7

SYSTEMDESCRIPTION.................................................................................................................... 7

TrialNeurostimulator(TNS) ............................................................................................ 9

ImplantableNeurostimulator(INS) ................................................................................. 9

ImplantLeads/TrialLeads/LeadExtension..................................................................10

ConnectorCableKit .......................................................................................................10

LeadAccessories ............................................................................................................10

ImplantationTools.........................................................................................................11

AdditionalAccessories ...................................................................................................11

ClinicalProgrammerandPatientProgrammer ...............................................................11

SterilizationInformation ................................................................................................12

StorageConditions.........................................................................................................12

ProductMaterials ..........................................................................................................12

SAFETYINFORMATION ..................................................................................................................13

• GeneralWarnings .................................................................................................13

• Warnings–ForUseinHomeorWorkEnvironments.............................................15

• Precautions ...........................................................................................................16

AdverseEvents ..............................................................................................................17

IMPLANTINGTHENEUROSTIMULATORSYSTEM ...................................................................................18

• PrecautionsfortheImplantProcedure .................................................................18

SelectionofNeurostimulatorTrialApproach .................................................................19

PreparingthePatientandDevicesforUse .....................................................................20

PlacingtheLead .............................................................................................................20

IntraoperativeTesting....................................................................................................25

RemovingtheDeliverySystemComponents–PercutaneousLeadTrial.........................26

LeadAnchoring–PercutaneousLeadTrial .....................................................................28

NeurostimulationTrial–PercutaneousLeadTrial...........................................................28

RemovingTrialLead–PercutaneousLeadTrial ..............................................................29

RemovingtheDeliverySystemComponents–ImplantLeadTrialOnly..........................29

LeadAnchoring ..............................................................................................................31

SpinalModulation,Inc. PhysicianImplantManual

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PercutaneousExtensionTunneling–ImplantLeadTrialOnly ........................................32

RemovingLeadExtension–ImplantLeadTrialOnly ......................................................33

CreatingtheINSPocket–Implant..................................................................................34

LeadorExtensionTunneling ..........................................................................................35

ConnectingLeadtoExtension ........................................................................................35

ConnectingtheINS.........................................................................................................36

ImplantingtheINS .........................................................................................................37

CheckingSystemIntegrity..............................................................................................38

CompletingtheProcedure .............................................................................................38

REPLACINGANINS ......................................................................................................................38

DisposingofanExplantedDevice...................................................................................39

APPENDIXA:TRIALLEADKIT/IMPLANTLEADKIT .............................................................................40

HowSupplied.................................................................................................................40

PackageContents...........................................................................................................40

DeviceSpecification .......................................................................................................41

APPENDIXB:TRIALNEUROSTIMULATOR ..........................................................................................42

DeviceDescription .........................................................................................................42

PackageContents...........................................................................................................42

DeviceSpecifications .....................................................................................................42

Handling ........................................................................................................................43

APPENDIXC:IMPLANTABLENEUROSTIMULATOR ................................................................................44

HowSupplied.................................................................................................................44

DeviceDescription .........................................................................................................44

PackageContents...........................................................................................................44

DeviceSpecifications .....................................................................................................44

Handling ........................................................................................................................45

DeviceLongevity............................................................................................................45

COMPANYANDAUTHORIZEDREPRESENTATIVECONTACTINFORMATION ..................................................46

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SpinalModulation,Inc. PhysicianImplantManual

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ExplanationofSymbolsonProductorPackageLabeling

ModelNumber

LotNumber

ConsultInstructionsforUse

ReadtheManual

Donotresterilize

SingleUseOnly

SterilizedbyEthyleneOxideGas

UseByYYYY‐MM

Opensterilepouchbypeelingpouchcorner

Opensteriletraybypeelingtraycorner

Manufacturer



ManufacturingDate

Warning



Standby

Caution



Notwaterproof

AppliestotheProgrammerwhenitisnotinitscarryingcase

SpinalModulation,Inc. PhysicianImplantManual

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Limitedwaterproof.AppliestotheTNS

AppliestotheProgrammerinitscarryingcase



ContentsofPackageareNon‐Sterile



KeepDry

Storagetemperature



Storebetween10%and90%humidity

SterileComponents



Storebetween0%and93%humidity

TNSandProgrammers

Thedeviceisaradiotransmitter

Magnet.ShowsthelocationoftheProgrammermagnet.

AuthorizedEuropeanRepresentative



RFOperatingFrequencies.Nearbyequipmentemittingstrongmagneticfieldscaninterferewith

RFcommunication,eveniftheotherequipmentcomplieswithCISPRemissionrequirements.The

operatingcharacteristicsareasfollows:



MICS/MedRadioband:402‐405MHz.Theeffectiveradiatedpowerisbelowthelimitsas

specifiedin

Europe:ENETSI301839‐2

USAFCC47CFRPart95;95.601‐95.673SubpartE,95.1201‐95.1219

FCCID:Y8L‐MN0200

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Thisdevicemaynotinterferewithstationsoperatinginthe400.150–406.000MHzbandinthe

MeteorologicalAids,MeteorologicalSatellite,andEarthExplorationSatelliteServicesandmust

acceptanyinterferencereceived,includinginterferencethatmaycauseundesiredoperation.

Introduction

ThismanualdescribestheAxium™NeurostimulatorSystem,includinginstructionsfor

implantation.Fordetailedoperationandclinicalprogramminginstructions,refertotheClinical

ProgrammerManual.

SpinalModulation,Inc. PhysicianImplantManual

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SystemOverview

TheAxium™NeurostimulatorSystemconsistsofanImplantableNeurostimulator(INS)device,

TrialNeurostimulator(TNS)device,aClinicalProgrammer,aPatientProgrammer,oneormore

leadswhichmaybeusedincombinationwithaleadextensionandtheaccessoriesandtools

usedforimplantingthesystem.TheTNSorINSisconnectedtoleadsplacedwithintheepidural

spacenearthedorsalrootganglion(DRG).Uptofourleadsmaybeplacedandconnectedto

theneurostimulatortoprovidestimulation.



PatientswhoareindicatedfortheAxium™ImplantableNeurostimulator(INS)Systemwillfirst

undergoatemporarytrialperiodusinganexternalTrialNeurostimulator(TNS)System

connectedtoimplantedleads.Ifboththeclinicianandpatientbelievethatsufficientpainrelief

wasachieved,thenthepatientwillbescheduledforanimplant,inwhichtheINSwillbe

implanted.

NOTE:Inthismanualthegeneralabbreviation“NS”isusedforinformationwhichappliesto

bothTNSandINS.Inallothercasesthespecificabbreviations“TNS”or“INS”areused.

SpinalModulation,Inc. PhysicianImplantManual

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IndicationsforUse

TheAxium™NeurostimulatorSystemisindicatedasanaidinthemanagementofchronic

intractablepainofthetrunkand/orlimbs.

Contraindications

PatientscontraindicatedfortheAxium™NeurostimulatorSystemarethosewho:

• Haveanactiveimplantablemedicaldeviceincludingbutnotlimitedtocardiac

pacemakersandcardiacdefibrillators

• Areunabletooperatethesystem

• Arepoorsurgicalrisks

• Arepregnant

• Areundertheageof18

SystemDescription

TheAxium™NeurostimulatorSystemconsistsofthefollowingcomponents:

Component

Name

Model

Numbers

PackageContentInstructionsforUse

Trial

Neurostimulator

MN10100

MN20100

• TrialNeurostimulatorTrialNeurostimulator

Manual

Implantable

Neurostimulator

MN10200

MN20200

• ImplantableNeurostimulator

• LeadPortPlugs(3)

• TorqueWrench

• SterileMagnetSleeve

• MedicalAlertCard

PhysicianImplant

Manual

TrialLeadKit

(lengthincm

specifiedby‐XX)



MN10350‐XX

MN20350‐XX



• TrialLead

• 22cmSmallCurveDeliverySheath

• 22cmBigCurveDeliverySheath

• Guidewire

• ComplexCurvedStylet

• 4.5”14GDeliveryNeedle

• SoftTissueAnchor(2)

PhysicianImplant

Manual

SpinalModulation,Inc. PhysicianImplantManual

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Component

Name

Model

Numbers

PackageContentInstructionsforUse

ImplantLeadKit

(lengthincm

specifiedby‐XX)



MN10450‐XX

MN20450‐XX

• ImplantLead

• 22cmSmallCurveDeliverySheath

• 22cmBigCurveDeliverySheath

• Guidewire

• ComplexCurvedStylet

• 4.5”14GDeliveryNeedle

• SoftTissueAnchor(2)

PhysicianImplant

Manual

ConnectorCable

Kit

MN11350

MN21350

• ConnectorCable

• LeadIdentifiers(3)

PhysicianImplant

Manual

TunnelingToolKit

30/51cm

MN11900

MN21900



MN12200

MN22200

• Tunnelingtool30/51cm

• Straw

• TrocarTip

• PencilTip

• INSSizer

• PortPlugs(3)

• TorqueWrench

PhysicianImplant

Manual

Clinical

Programmer

MN10700

MN20700

• ClinicalProgrammer

• ExternalMagnet

• ProgrammerCharger

• CarryingCase

ClinicalProgrammer

Manual

Patient

Programmer

MN10600

MN20600

• PatientProgrammer

• ExternalMagnet

• ProgrammerCharger

• CarryingCase

• MedicalAlertCard

PatientProgrammer

Manual

AuxiliaryMagnet

Kit

MN13300

MN23300

• AuxiliaryMagnetAncillaryItemsManual

Programmer

ChargerKit

MN13400

MN23400

• ProgrammerChargerAncillaryItemsManual

Programmer

CarryingCase

MN13500

MN23500

• ProgrammerCarryingCaseAncillaryItemsManual

LeadAccessories

Kit



MN12050

MN22050

• 4.5”14GDeliveryNeedle

• 6.0”14GDeliveryNeedle

• SoftTissueAnchor

• ComplexCurvedStylet

• 30cmBigCurveDeliverySheath

• 30cmSmallCurveDeliverySheath

PhysicianImplant

Manual

SpinalModulation,Inc. PhysicianImplantManual

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Component

Name

Model

Numbers

PackageContentInstructionsforUse

22cmSmallCurve

DeliverySheathKit

MN12150

MN22150

• 22cmSmallCurveDeliverySheaths(2)PhysicianImplant

Manual

22cmBigCurve

DeliverySheathKit

MN13650

MN23650

• 22cmBigCurveDeliverySheaths(2)PhysicianImplant

Manual

4.5”NeedleKitMN11700

MN21700

• 4.5”14GDeliveryNeedlePhysicianImplant

Manual

LeadExtensionKit

(lengthincm

specifiedby‐XX)

MN10550‐XX

MN20550‐XX

• LeadExtension50cm

• TorqueWrench

PhysicianImplant

Manual



TrialNeurostimulator(TNS)

TheexternalTNSdeviceconnectstotheTrialLead(s)orLead

Extensionsandiswornbythepatientforupto30daysduring

thetrialperiod.TheTNSdevicehasabeltclipforthepatient’s

convenience.



ImplantableNeurostimulator(INS)

TheAxium™ImplantableNeurostimulator(INS)isanon‐rechargeable,4channelelectronic

device.Itusesmicroelectroniccircuitry,poweredbyahermeticallysealedbattery,togenerate

apulsedwaveformtostimulateneuraltissue.Theelectroniccircuitryandbatteryarehoused

inahermeticallysealedtitaniumcase.



Eachneurostimulatorhasauniqueinternalidentifierthatallowsthephysiciantoidentifythe

typeofdevicethroughanX‐ray.Theradiopaqueidentifierinsidethecaseallowsidentification

ofboththedevicemanufacturerandmodelnumberusingstandardx‐rayequipment.Forthe

Axium™Neurostimulator,thecodeisSM001whichidentifiesSpinalModulationasthe

manufacturerandMN10200/MN20200asthemodelnumber.

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SpinalModulation,Inc. PhysicianImplantManual

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TheINSispackagedinasealedinnertraywithinasealedoutertray.

ImplantLeads/TrialLeads/LeadExtension

TheLeadKitscontaintheLeadsandtheindividualdeliverydevicesthatarerequiredfortheir

placement.

CAUTION:ThetemporarilyplacedTrialLeadsareintendedforuseforupto30days.

• Implant/TrialLeads:TheLeadsaredesignedforpercutaneousintroductionintothebody

usingaspecialneedleandasetofcustomdeliverytoolsprovidedintheirrespectivekits.

EachLeadisfittedwithfourcylindricalelectrodesspacedatequalintervalswhichare

intendedtoprovidestimulationatthetargetdorsalrootganglion(DRG).EachLeadis

packagedwithaComplexCurvedStyletinsertedintotheLeadandtheLeadispre‐loaded

intoa22cmSmallCurveDeliverySheathforthephysician’sconvenience.

• LeadExtension:TheLeadExtensionconsistsofasiliconeportheaderthatacceptsthe

SpinalModulationTrialLeadandImplantLead.Itisintendedtoextendthelengthofthe

leadandprovideaconnectionbetweentheleadandtheConnectorCableortheleadand

theImplantableNeurostimulatorSystem.TheLeadExtensionisintendedforchronic

implantationasacomponentoftheAxium™NeurostimulatorSystem.

ConnectorCableKit

TheConnectorCableconnectstheLeadsorLeadExtensiontotheexternalTNS.

• ConnectorCable:TheConnectorCableispackagedseparatelyfromtheLeadandLead

ExtensionKit.TheConnectorCableincludesaconnectorand2extensioncablesforuse

asneeded.

• LeadIdentifiers:TheLeadIdentifiersaresmallbentwiresthatcanbeinsertedintothe

proximalstyletlumenintheleadsandareindividuallycoloredtoidentifytheleads.

LeadAccessories

• Small/BigCurveDeliverySheath:TheDeliverySheathsareintendedtoallowpassageof

theleadpercutaneouslyintotheepiduralspace.Thelabeledlengthofthesheathisthe

distancefromthehubtothepre‐shapedtipandthelengthofthecurveatthetipis

approximately2mmfortheSmallCurveandapproximately8mmfortheBigCurve.

• ComplexCurvedStylet:TheComplexCurvedStyletisintendedtoassistinsteeringand

positioningtheleadwithintheepiduralspace.TheComplexCurvedStylethasbeenpre‐

insertedintotheLeadforthephysician’sconvenience.

• 14GDeliveryNeedles:TheDeliveryNeedleisintendedtoaccesstheepiduralspace,

providingaconduitforlead,guidewireanddeliverysheathplacement.

• Guidewire:TheGuidewireisintendedtoverifythattheneedleisintheepiduralspace

afterusingalossofresistancetechnique.

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• SoftTissueAnchor:TheSoftTissueAnchorsareintendedtoanchortheLeadinthesoft

tissueorontheskinsurfaceproximaltothedistalcontactsoftheLead.

ImplantationTools

• TunnelingTool:ThetunnelingtoolisusedtoprovideaconduitfortheTrialLead,Implant

Lead,orLeadExtensiontotheINSorawayfromthemidlineofthespine.Itispackaged

with2exchangeabletips:abluntpenciltipandasharptrocartip.Astrawisslidoverthe

tunnelingtoolandwhenthesteelhandleisremoved,thestrawprovidestheconduitfor

tunneling.

• INSSizer:TheINSSizerisapproximatelythesamesizeastheINSandallowsthephysician

toproperlysizetheINSpocket.

• PortPlugs:TheportplugsareusedtofillunusedportsintheINS.Theyarepackagedwith

theINS,butspareportplugsarealsopackagedwiththeTunnelingToolKitsforthe

convenienceofthephysician

AdditionalAccessories

• SterileMagnetSleeve:Themagnetisplacedinthesterilesleevetoallowittobeused

duringtheimplantationoftheINS.

• MedicalAlertCard:IdentifiesthepatientasauseroftheNeurostimulationSystem.

• ProgrammerCharger:TobeusedwiththeClinicalorPatientProgrammerstochargethe

batteryorallowuseoftheProgrammerswhilepluggedintostandardelectricaloutlets.

• ProgrammerCarryingCase:ProtectstheProgrammersfromwater.

• AuxiliaryMagnet:AllowstheusertotheturntheNSofforactivatesRFtoallowtheuserto

communicatewiththeNS.



ClinicalProgrammerandPatientProgrammer

TwoprogrammersareavailabletointeractwiththeNSdevice.

1. TheClinicalProgrammerisusedtoprogramthe

stimulationparametersforboththeTNSand

theINS.Theinstructionsforprogrammingthe

TNSandINSdevicesarethesame.TheClinical

Programmerisusedbythephysicianorclinical

staff.

2. ThePatientProgrammerallowsthepatientto

adjustthestimulationsettingsoftheTNSand

INSdeviceswithinlimitspresetbytheclinician.

ThePatientProgrammeralsoallowsthepatient

toturnstimulationoff,ifnecessary.

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Note:FordetailedinformationandinstructionsrelatedtotheClinicalandPatient

ProgrammerandtheTrialNeurostimulator,refertotherespectiveusermanuals.

SterilizationInformation

Single‐use,steriledevice‐ThesterilecomponentsoftheAxium™NeurostimulatorSystemare

providedsterileinadoublepouchortrayassemblyandareintendedforsingleuseonly.An

expirationdate(or“use‐before”date)ismarkedonthelabelofeachpackage.Useproper

steriletechniquestoopenthepackaging.

WARNING:Donotresterilizeorreuseanydevicesforanyreasonbecauseofriskof

infectiontothesubjectandmalfunctionofthedevices.

Sterilization–TheSpinalModulationINS,TrialLeadKit,ImplantLeadKit,LeadExtensionKit,

LeadAccessoriesKitandTunnelingToolKitshavebeensterilizedusingethyleneoxide(EO)gas.

StorageConditions

StoreallsterileproductincludingtheINS,Leads,andLeadAccessoriesKitsasfollows:

StorageTemperature–Storecomponentsbetween14°F(‐10°C)and122°F(50°C).

Temperaturesoutsidethisrangemaydamagethecomponents.Ifatemperaturedeviationhas

occurred,donotusetheproduct.

StorageHumidity–Storecomponentsbetween10%and90%humidity.

StorageEnvironment–Storecomponentsandtheirpackagingwheretheywillnotcomein

contactwithliquidsofanykind.

ProductMaterials

PortionsoftheAxium™NeurostimulatorSystemwillcomeincontactwithbodilytissues.

WARNING:Neurostimulationsystemshavematerialsthatcomeincontactwithtissue.A

physicianshoulddeterminewhetherornotapatientmayhaveanallergicreactionto

thesematerialsbeforethesystemisimplanted.

Thefollowingmaterialsareimplantedandcomeincontactwithtissue:

• Platinumiridium• StainlessSteel

• Polyurethane• MP35N(nickel‐cobalt‐chromium‐molybdenumalloy)

• Titanium • PEEK(polyetheretherketone)

• Epotek• PFA(perfluoroalkoxycopolymerresin)

• Siliconerubber• PMMA[poly(methylmethacrylate)]

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SafetyInformation

GeneralWarnings

ThefollowingwarningsapplytotheuseoftheAxium™NeurostimulatorSystem:

• ExternalDefibrillators–Safetyforuseofexternaldefibrillatordischargesonapatient

receivingneurostimulationhasnotbeenestablished.

• MagneticResonanceImaging–Thepatientshouldbeadvisedtonotundergoany

electivemagneticresonanceimaging(MRI)withthesysteminplace.UseofMRIinthe

vicinityofthelead(s)mayresultinforcefuldislodgmentofthelead(s),ordamagetothe

Neurostimulator.Ifavoltageisinducedthroughthelead,itmaycauseuncomfortable

(“jolting”or“shocking”)levelsofstimulationorinjurytothepatient.

• UltrasonicScanning–Ultrasonicequipmentmaycausemechanicaldamagetothelead

ifuseddirectlyoverthesite.

• ElectrosurgeryDevices–Electrosurgerydevicesshouldnotbeusedincloseproximityto

implantedlead(s).Contactbetweenanactiveleadandtheelectrosurgicalpencilcan

causedirectstimulationofthecontactednerveandcancausesevereinjurytothe

patient.Electrosurgerydevicesmayalsodamagetheleadandcausealossof

stimulation.

• PediatricUse–Useofneurostimulationhasnotbeenapprovedspecificallyforchildren

lessthan18yearsofage.

• Pregnancy–Safetyandeffectivenessofneurostimulationforuseduringpregnancyand

nursinghavenotbeenestablished.

• Non‐EmergencyProcedures–Thepatientmustbeadvisedthattheymustnothavenon‐

emergencyprocedureswhiletheyareundergoingtrialstimulation.

• EmergencyProcedures–Thepatientshouldbeinstructedtodesignatearepresentative

(familymemberorclosefriend)tonotifyanyemergencymedicalpersonneloftheir

neurostimulatorimplant,ifemergencycareisrequired.Eachpatientalsowillbe

providedwithaMedicalAlertCardtocarrywiththemthatwillinformemergency

medicalpersonnelofthepatient’simplant.Thepatientshouldbeadvisedtouse

cautionwhenundergoinganyprocedurethatcouldincludeRFormicrowaveablation,

defibrillationorcardioversion.

• RoutineMedicalProcedures–Thepatientshouldbeinstructedtonottoundergo

dentalprocedures,diathermy,electrolysis,diagnosticultrasound,staticfield

therapeuticmagnets,diagnosticX‐ray,andhighoutputultrasoniclithotripsy.These

proceduresmayprovideinterferencethatcanaffectTNSorINSdeviceoperationoruse

ordamagecomponentsofthesystemthatmaycausepatientharm.

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IfthepatientwithanINSorTNSdeviceissubsequentlygivenanymedicaltreatmentin

whichanelectricalcurrentispassedthroughhis/herbodyfromanexternalsource,

eitherthedeviceshouldfirstbedeactivated,orcareshouldbetakentomonitorthe

functioningoftheneurostimulatorduringtheinitialstagesoftreatment.

• DiathermyTherapy–Donotuseshort‐wavediathermy,microwavediathermy,or

therapeuticultrasounddiathermy(allnowreferredtoasdiathermy)onpatients

implantedwithaneurostimulationsystem.Energyfromdiathermycanbetransferred

throughtheimplantedsystemandcausetissuedamageatthelocationoftheimplanted

electrodes,resultinginsevereinjuryordeath.Diathermyisfurtherprohibitedbecause

itmayalsodamagetheneurostimulationsystemcomponents.Thisdamagecouldresult

inlossoftherapy,requiringadditionalsurgeryforsystemimplantationand

replacement.Injuryordamagecanoccurduringdiathermytreatmentwhetherthe

neurostimulationsystemisturnedonoroff.Allpatientsareadvisedtoinformtheir

healthcareprofessionalsthattheyshouldnotbeexposedtodiathermytreatment.

• CardiacPacemakersandImplantableCardiacDefibrillators(ICD)–Itispossiblethatthe

devicemayaffecttheoperationofotherimplantabledevicessuchaspacemakersor

implantablecardiacdefibrillators.Thephysicianshouldbeawareofanyother

implantabledevicesthepatientmayhaveorisscheduledtoreceive.

• ExplosiveorFlammableGases–Donotusethepatientprogrammerorclinical

programmertocommunicatewiththeINSorTNSinanenvironmentwhereexplosiveor

flammablegasfumesorvaporsarepresent.Theoperationoftheprogrammercould

causethemtoignite,causingsevereburns,injury,ordeath.

• CaseDamage–IftheINScaseispiercedorruptured,anexplosioncanoccurfromthe

batterychemicals,whichcanleadtosevereburnsorevendeath.

• DeviceComponents–TheuseofnonSpinalModulationcomponentswiththesystem

mayresultindamagetothesystemandincreasedriskofharmtothepatient.

• ComponentDisposal–ReturnallexplantedNeurostimulatorstoSpinalModulationfor

safedisposal.Donotcrush,puncture,orburntheNeurostimulatorbecauseexplosion

orfiremayresult.

• ExposuretoFluids–ExposureoftheexternalTNSortheConnectorCabletowater,

bodyfluids,saline,orcleaningagentscancausecorrosionandaffectstimulation.Ifthis

occurs,dryallcomponentsthoroughlypriortoleadconnection.Donotimmersethe

externalTNSorConnectorCableinfluids.

• DeviceHandling‐ ThepatientmustbeinstructedtonotremovetheirTrialLead(s)or

ConnectorCable.Manipulationofthecomponentsmayresultinanundesiredoutcome,

suchasthepatientdevelopinganinfection,gettingundesirablestimulation,or

accidentallyturningtheirstimulationoff.Thepatientmustbeinstructedtonotrubor

exertpressureontheimplantableneurostimulatorthroughtheskinasthismaycause:

leaddislodgementleadingtostimulationattheimplantsite,deviceinversionleadingto

theinabilitytocommunicatewiththedevice,orskinerosionthatcanleadtoanother

surgicalprocedureorpossibleinfection.

SpinalModulation,Inc. PhysicianImplantManual

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15

Warnings–ForUseinHomeorWorkEnvironments

• EquipmentOperation–Duringstimulation,patientsshouldbeadvisedtonotoperate

potentiallydangerousequipment,suchaspowertools,automobiles,orothermotor

vehicles.Theyshouldnotclimbladdersorparticipateinotheractivitieswherepostural

changeoranabruptmovementcouldaltertheperceptionofstimulationintensityand

causepatientstofallorlosecontrolofequipmentorvehiclesorinjureothers.

• PatientActivity–Patientsshouldbeadvisedtolimittheiractivitiestolowormoderate

levelsduringtheirtrialstimulationperiodandthefirstsixweeksofimplantationofthe

INS.Failuretodosomayresultinmigrationoftheleadscausinglossofstimulation

therapy,musclestimulationorpainfulstimulationtherebyrequiringreoperationto

reposition.

• TheftDetectorsandMetalScreeningDevices–Certaintypesofantitheftdevices,such

asthoseusedatentrances/exitsofdepartmentstores,libraries,andotherpublic

establishments,and/orairportsecurityscreeningdevicesmayaffectstimulation.Itis

possiblethatpatientswhoareimplantedwithnon‐adjacentmultipleleadsand/or

patientswhoaresensitivetolowstimulationthresholdsmayexperienceamomentary

increaseintheirperceivedstimulation,whichhasbeendescribedbysomepatientsas

uncomfortableorjolting.Itisrecommendedthatpatientsusecautionwhen

approachingsuchadeviceandthattheyrequestassistancetobypassthedevice.Ifthey

mustproceedthroughthedevice,patientsshouldturnofftheNSandproceedwith

caution,beingsuretomovethroughthedetectorquickly.

• RestrictedAreas–Thepatientshouldbewarnedtoseekmedicalguidancebefore

enteringenvironmentswhichcouldadverselyaffecttheoperationoftheimplanted

device,includingareasprotectedbyawarningnoticepreventingentrybypatientsfitted

withapacemaker.

• ElectromagneticInterference(EMI)–Certaincommercialequipmentsuchasresistance

weldersandinductionfurnaces,certaincommunicationequipmentsuchasmicrowave

transmitters,linearpoweramplifiers,andhighvoltagepowerlinesmaygenerate

sufficientEMItointerferewiththeINSandTNSSystemresultinginunderstimulation,

overstimulation,ordifficultyindevicecommunications.Certainmedicaldevicesmay

alsocauseEMIinterferenceandmakeitdifficulttocommunicatewiththeINSorTNS;

suchdevicesincludebonegrowthstimulators,transcutaneouselectricalnerve

stimulation(TENS),andimplantedcardiacdevices.

• LeadMovement–Thepatientshouldbeinstructedtoavoidexcessivebending,twisting,

andstretching,enteringhyperbaricchambersabove2.0atmosphere,andoperatingthe

neurostimulatorwhiledrivingorliftingobjectsofover2Kg(5lbs)foraminimumof6

weeksafterimplantation.Theseactivitiesmaycauseleadmovement,whichcanresult

inunderstimulationoroverstimulationforthepatient.Excessiveleadmigrationmay

leadtotheneedforreoperationtoreplacetheleads.

SpinalModulation,Inc. PhysicianImplantManual

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• TherapeuticRadiation–Therapeuticradiationmaydamagetheelectroniccircuitryof

animplantedneurostimulationsystem,althoughnotestinghasbeenperformedandno

definiteinformationonradiationeffectsisavailable.Sourcesoftherapeuticradiation

includex‐rays,cobaltmachines,andlinearaccelerators.Ifradiationtherapyisrequired,

theareaovertheimplantedINSshouldbeshieldedwithlead.

Precautions

ThefollowingprecautionsapplytotheuseoftheAxium™NeurostimulatorSystem:

• PhysicianTraining–Implantingphysiciansshouldbeexperiencedinthediagnosisand

treatmentofchronicpainsyndromesandhaveundergonesurgicalanddevice

implantationtraining.

• PatientSelection–Itisextremelyimportanttoselectpatientsappropriatelyfor

neurostimulationandthatthoroughpsychiatricscreeningbeperformed.Patients

shouldnotbedependentondrugsandshouldbeabletooperatethespinalcord

stimulatorsystem.

• Infection–Itisimportanttofollowproperinfectioncontrolprocedures.Infections

relatedtosystemimplantationmightrequirethatthedevicebeexplanted.

• ImplantationofTwoSystems–Iftwosystemsareimplanted,ensurethatatleast15cm

(6in)separatestheimplantedINSstominimizethepossibilityofinterferenceduring

programming.

• ImplantationofMultipleLeads–Ifmultipleleadsareimplanted,leadsandextensions

shouldberoutedincloseproximity.Nonadjacentleadscanpossiblycreateaconduitfor

strayelectromagneticenergythatcouldcausethepatientunwantedstimulation.

• HighStimulationOutputs–Stimulationathighoutputsmaycauseunpleasant

sensationsormotordisturbancesormayrenderthepatientincapableofcontrollingthe

patientprogrammer.Ifunpleasantsensationsoccur,thedeviceshouldbeturnedoff

immediately.

• StimulationParameters–Patientsshouldbecautionedthatstimulationparameters

mustbedeterminedunderthesupervisionofaphysicianandthattheyshouldnot

adjuststimulationparameterswithinprescribedprogramsunlessorderedtodosobya

physician.

• CellularPhones–Theeffectofcellularphonesonneurostimulationsystemsis

unknown;patientsshouldavoidplacingcellularphonesdirectlyoverthesystem.

• TrialLeads–TrialLeadsareintendedforuseforupto30days.Useofthesedevices

mustbeperformedinaccordancewiththeinstructionsprovidedinthismanual.

• Overprogramming–Excessivecommunicationwiththedevicecanshortenthelifeof

theINS.Thepatientshouldbewarnedtocommunicatewiththedeviceonlywhen

necessary.

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• TNSDeviceCare–Thepatientmustbeinstructedtonotspillfluidson,towashor

otherwisegettheirTNSdevicewet.Thepatientmustnotshowerorbathewithit

(spongebathsareacceptableaslongastheTNSdevicedoesnotgetwet).Thepatient

mustbeinstructednottodropormishandletheirTNSdevice.Physicaldamagetothe

unitmayimpairitsfunction.ThepatientmustbeinstructedtonotopentheTNScase.

• LeadandCableCare–Thepatientmustbeinstructedtonotremovetheirlead(s)or

ConnectorCableduringthetrialperiod.Manipulationofthecomponentsmayresultin

thepatientdevelopinganinfection,gettingundesirablestimulation,oraccidentally

turningtheirstimulationoff.

• TNSDeviceFailure–Devicefailure,althoughunlikely,ispossibleduetorandom

componentfailure.IftheTNSdevicestopsworking,thepatientshouldcontacttheir

physician.

• TNSDeviceDisposal–ThepatientistobeinstructedthattheymustreturntheirTNS

deviceandPatientProgrammertotheirphysicianafterthetrialperiod.Thepatient

mustbeinstructedtonotdiscardorburntheirTNSdevice.Firemaycausetheinternal

batterytoexplode.

• TNSBatteryReplacement–Itisunlikelythatthebatterywillneedreplacementinthe

shorttimethatthepatienthastheirTNSdevice.However,iftheTNSdevicedoesnot

functionthepatientmustnottrytoopentheTNScase.Theinternalbatterymustbe

replacedbySpinalModulationpersonnelonly.Thepatientshouldbeadvisedtocontact

theirphysicianduringregularbusinesshours.

• MaterialSensitivity–Hypersensitivity(rednessintheareaofskincontact)canhappen

ifthepatienthasanallergicreactiontothematerials.Ifthisoccurs,thepatientshould

beinstructedtocontacttheirphysicianduringregulatorbusinesshours.

AdverseEvents

Theimplantationofaneurostimulationsysteminvolvesrisk.Inadditiontothoserisks

commonlyassociatedwithsurgery,thefollowingrisksarealsoassociatedwith

implantationanduseoftheAxium™NeurostimulatorSystem:

• Pain(wheretheneedlehasbeeninserted)

• Pain(causedbyunderstimulationduetoleadmigration)

• Painovertheimplantableneurostimulatorsite

• Escalatingpain

• Bleeding(wheretheneedlehasbeeninserted)

• Headache

• Infection

• Localizedcollectionofserous(clear)fluidatinjectionsite

• Discomfortduringthetreatment

• Allergicorrejectionresponsetoimplantmaterials

• Constantpainattheleadsite

• Stimulationofthechestwall

• Leadmigration(movement)and/orlocalskinbreakage

SpinalModulation,Inc. PhysicianImplantManual

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• Weakness

• Clumsiness

• Numbness

• Temporarymuscleactivation



Veryrarerisksandsideeffectsinclude:

• CerebralSpinalFluid(CSF)leakage

• Tissuedamage

• Nervedamage

• Spinalcordcompression

• Paralysis

• Hematoma

• Swelling

• Seroma

• Sensoryloss

• SkinerosionaroundtheINSorleads

• Batteryfailureand/orbatteryleakage

• Leadbreakagerequiringreplacementofthelead

• Hardwaremalfunctionrequiringreplacementoftheneurostimulator

• Painfromanon‐injuriousstimulustotheskin(allodynia)

• Anexaggeratedsenseofpain(hyperesthesia)



Additionalriskstothesubjects,asaresultoftheplacementandstimulationoftheleadinthe

areaoftheDRG,includepotentialtissuedamageorpainduetosettingthestimulation

parameterstoohigh.Thismayoccuroncetheleadisinplaceandisconnectedtothe

neurostimulatorandactivated.Theneurostimulatoriscontrolledbyatrainedoperatorandthe

startingpointforthestimulationwillbesettothelowestavailablesettings.Additionally,all

subjectswillbeawakeandconversantduringtheproceduretominimizethelikelihoodofany

nervedamage.

ImplantingtheNeurostimulatorSystem

PrecautionsfortheImplantProcedure

• Allimplantingphysiciansshouldbeexperiencedinthediagnosisandtreatmentof

chronicpainsyndromesandhaveundergonesurgicalanddeviceimplantationtraining.

• Donotbend,kink,orstretchtheleadbody,sheaths,orothercomponentsasthismay

resultindamagetothecomponentandpoorfunction.

• Donotinsertthesheathintotheepiduralspacewithouttheleadinserted,asthismay

causeinjurytothedura.Theleadcannotbeinsertedintothesheathwiththesheathin

theepiduralspace.

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• Wheninsertingthelead/sheathassemblythroughtheneedleintotheepiduralspace,

tightentheleadstabilizertopreventleadmigrationoutofthesheath.Failuretodoso

maycauseharmtothepatientsuchasdamagetothedura.

• Donotbendthesheathwithouttheleadinsidethesheath,asthiswillpermanentlykink

itandmakeitdifficulttodeploythelead.

• Donotusesurgicalinstrumentstohandlethelead.Theforceoftheinstrumentsmay

damagetheleadorleadstylet.

• Donotbend,kinkorusesurgicalinstrumentsonthestylet,asthismaydamageit.Use

carewhenreinsertingastylet.Toomuchpressureonthestyletcoulddamagethelead,

resultinginintermittentorlossofstimulation.

• Donotovermanipulatethesheathandleadsystemasthismayresultintraumawithin

theepiduralspace.

• Donotusesalineorotherionicfluidsatornearanyoftheelectricalconnections,asthis

couldresultinshortcircuits.

• Donotplacesuturesdirectlyaroundtheleadbodysincethesuturesmaydamagethe

lead.

• Beforeopeninganysterilepackage,verifythekitmodelnumber,thatthekitiswithinits

expiration(use‐by)dateandthatthepackaginghasnotbeendamagedorcompromised

inanyway.Ifthepackaginghasbeencompromisedorthedeviceisbeyondits

expirationdate,donotusethedeviceasitmaybecompromisedandcouldcauseharm

tothepatient.

• Carefullyinspectthelead(inthesterilefield)fordamageafterremovingitfromthe

sterilepackage.Damagetotheleadbodycancauseimproperfunctionandstimulation

orstimulationtoareasotherthantheintendedtarget.

• Iftheoperatingfieldisbloody,wipegloves,lead,stylet,andsheath,beforehandlingthe

lead.Failuretodosomayresultindifficultydeliveringthelead.

• Theleads,accessories,andneurostimulatorareonlycompatiblewiththeSpinal

Modulationcomponents.Useofothermanufacturer’scomponentsmayresultin

unexpecteddeviceperformanceandincreasedriskofinjurytothepatient.

SelectionofNeurostimulatorTrialApproach

Therearetwosuggestedapproachesforaneurostimulationtrial:

A. PercutaneousLeadTrial‐AtrialisdoneusingaTrialLeadwhichexitstheskinattheneedle

entrysiteandwhichiscompletelyremovedafterthetrialperiod.Inasecondprocedure,

thesystemisimplanted,includingtheImplantLeads.

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B. ImplantedLead+PercutaneousExtensionTrial–AtrialisdonewithanImplantLead

suturedtothesofttissuejustabovethespinousprocess,usingthesofttissueanchorto

protectthelead.Anextensionistunneledawayfromtheneedleinsertionsitewhereit

exitstheskin.InasecondprocedureonlytheLeadExtensionisremovedandtheLeadora

newLeadExtensionistunneledtoapocket,theINSisimplantedinthepocket,andthe

LeadorLeadExtensionisconnectedtotheINS.

PreparingthePatientandDevicesforUse

Leadsaredesignedforplacementintheepiduralspace.EachLeadisaccompaniedby

accessoriesdesignedtoaidtheclinicianinpositioningthetipoftheLeadnearthetargetDRG.

• ToperformaPercutaneousLeadtrial,usethetemporaryTrialLeadKit.

• ToperformanImplantLeadtrial,usetheImplantLeadKit.

CAUTION:ThetemporarilyplacedTrialLeadsareintendedforuseforupto30days.Useof

thesedevicesmustbeperformedinaccordancewiththeinstructionsprovidedinthis

manual.

Usingstandardsteriletechnique,performtheappropriateskinprepping,draping,andinjection

oflocalanesthetictoperformtheepiduralapproachesforpercutaneousleadplacement.

WARNING:Theplacementoftheleadsinvolvessomerisk,aswithanysurgical

procedure.Conscioussedationcancausesideeffectssuchassystemictoxicity,or

cardiovascularorpulmonaryproblems.Usecautionwhensedatingthepatient.The

patientmustbeawakeandconversantduringportionsoftheproceduretominimizethe

likelihoodofnervedamage.

PlacingtheLead

Leadplacementshouldalwaysbedoneunderfluoroscopicguidance.Theappropriatevertebral

levelforneedleentryshouldbeidentifiedandmarked.

WARNING:Aswithanyspinalepiduralprocedure,potentialrisksofseriousinjurytothe

patient,althoughextremelyrare,includeepiduralhemorrhage,hematoma,infection,

spinalcordornervecompression,and/orparalysis.

1. Determinethelengthoftheleadrequiredtoextendfromthetargetforaminalleveltothe

Neurostimulatorimplantationsite.Usinga90cmleadinthelumbarregionmaycause

difficultyincoilingtheexcesslead.A50cmleadusedintheupperthoracicregionmaynot

belongenoughtoreachtheNeurostimulatorandaleadextensionmaybeneededtobridge

theadditionallength.

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ChoosinganApproach

2. AntegradeApproach

Underfluoroscopicguidance,useacontralateralapproach,withthebeveloftheneedle

facingtowardthetargetlevel,toinserttheDeliveryNeedleintotheepiduralspaceatthe

appropriateangleuntilyouencounterresistancefromtheligamentumflavum.Startoneor

twolevelsbelowthetargetsite.Theneedleangleshouldbenogreaterthan30degreesto

ensuresmoothdeliveryofthedeliverysheathandlead.



  

SingleLevelDeliveryApproachTwoLevelDeliveryApproach

3. ContralateralApproach

Underfluoroscopicguidance,useacontralateralapproachwiththebeveloftheneedle

facingtowardthetargetleveltoinsertthe14Gdeliveryneedleintotheepiduralspace.

WARNING:Whenusingacontralateralapproach,advancetheneedleslowlyintothe

epiduralspaceandtakecautionasitenters.Theneedlewillbeinsertedatasteeper

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anglethaninanantegradeapproachandthereisagreaterchanceofduralpuncturethat

willleadtoacerebrospinalfluidleak.



4.

Confirmentryintotheepiduralspaceusingstandardmethods,suchasalossofresistance

technique.



5. Oncelossofresistanceisachieved,theclinicianmayverifycompleteinsertionintothe

epiduralspaceusingfluoroscopicguidanceand/orinsertingtheguidewirethroughthe

needle.Ifresistanceisdiscoveredduringguidewireinsertion,eitherpulltheneedleoutand

repeatSteps1‐4usingamoreacuteangleoradvancetheneedlefurtherandreconfirm

placementusingtheguidewire.

WARNING:Usefluoroscopyandextremecarewheninserting,advancing,or

manipulatingtheguidewireorleadintheepiduralspacetominimizetheriskofadural

tear.

WARNING:Duralpuncturecanoccurifneedleorguidewireisadvancedaggressivelyonce

lossofresistanceisachieved.Advancetheneedleand/orguidewireslowly.

6. Removetheguidewire(ifused)afterconfirmationofaccesstotheepiduralspace.

NOTE:TheComplexCurvedStylethasbeenpre‐insertedintotheleadandtheleadhasbeen

loadedintoa22cmSmallCurveSheathtofacilitatedeliverybytheclinician.

7. Beforeinsertionintotheneedle,pushtheleadoutsidethesheathandverifythatthestylet

ispushedfullydistalwithinthelead.

NOTE:Failuretoensurethestyletiscompletelyinsertedmaymakedeliveryofthelead

moredifficult.

8. Beforeinsertionintotheneedle,pullbackontheleadsothattheball‐tipendoftheleadis

flushagainsttheDeliverySheathandtightendowntheleadstabilizeruntiltheleaddoes

notslidewithinthesheath.

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

TighteningtheLeadStabilizer

WARNING:Insertionofasheathwithouttheleadmayresultinduralpuncture.Securing

theleadwiththeleadstabilizerwillmitigatethisrisk.

WARNING:UseofthedeliverysheathisnecessaryforsuccessfulplacementoftheLead.

9. Notethatthesteeringwingonthesheathlinesupwiththebendinthesheath.



10. Beforeinsertingthesheathintotheneedle,verifythattheLeadisloaded.TheLeadcannot

bedeliveredthroughthesheathoncethesheathislocatedwithintheepiduralspace.

11. Insertthesheath,lead,andstyletthroughtheneedleandadvancethroughtheepidural

spacetothetargetforaminalopening.



WARNING:Ifthesheathneedstoberetractedfromtheepiduralspace,verifythatthe

steeringwingisnomorethan90degreesmisalignedwiththemarkontheneedle.Failure

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todosomayresultindamagetothesheath.Beforereinsertingsheath,verifythereisno

damagetothesheath.



WARNING:Ifthesheathisnotrespondingtorotation,donotrotatethesteeringwing

outofplanefromthecurveofthesheathmorethan90degrees.Thetipofthesheath

maywhiparoundandcouldcauseharmtothepatient.

12. Withthedistalendofthesheathinoratthetargetforamen,loosentheleadstabilizer,

andadvancetheleadsothatitmovesintotheforamen.Confirmplacementoftheleadon

thedorsalsideoftheforamenusingalateralfluoroscopicview.Verifythattheelectrodes

extendoutofthesheath.Iftheelectrodesremainwithinthesheath,stimulationwillnot

bepossiblebecauseofhighimpedancereadings.



LooseningtheLeadStabilizer

WARNING:Iftheleadisunabletodeployoutofthesheath,injectsterilewaterorsaline

slowlytoreleasetissuethatmayhaveenteredbetweenthesheathandthelead.Donot

useexcessivepressurewheninjectingthroughthesheath.

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

LeadAdvancedAlongDorsalAspectofDRG

WARNING:Donotuseexcessiveforcetopushtheleadorsheathintotheneural

foramenasthismayresultinpermanentortransientnervedamage.Thepatientshould

beawakeandconversantduringthispartoftheproceduresotheycanprovidefeedback

tothephysician.

IntraoperativeTesting

1. Connecttheheadtothecable.Pressandholdthecablebuttondowntoreleasethe

lockingmechanismandslidetheproximalendoftheleadsintothehead.Releasethe

cablebuttontolocktheleadintoplace.Verifythattheleadcomestoastopbefore

releasingthebutton.Thiswillensurethattheelectricalcontactsareintheappropriate

position.



2. PuttheTNSinstandbymodeorturntheamplitudeofeachleadsettozero.

PRECAUTION:Putthetrialstimulatorinstandbymodeorreduceamplitudeofleadsto

zerobeforeplugginginthecable.Failuretodosomayresultindeliveringan

uncomfortablestimulationtothepatient.

3. PasstheproximalendoftheConnectorCableoffthesterilefieldandconnecttotheTNS.

Head

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NOTE:RefertotheTrialNeurostimulatorUserManualandClinicalProgrammerUser

Manualforspecificinstructionsontheoperationofthesedevices.

WARNING:Maintainadequateslackinthecable.Ifthereisnotenoughslackandthe

cableispulled,theleadmaybedislodgedandwillneedtobereplaced.Thiswillextend

theprocedure.

4. UsingtheTNS,testthevariouselectrodeconfigurationsusedtoobtainappropriate

paresthesiaorpainrelief.

5. TurnofftheTrialNeurostimulatoranddisconnecttheleadfromtheconnectorcable.

6. Uptofourleadsmaybeplacedinonepatient.Referto“PlacingtheLead”toposition

subsequentleads.

WARNING:AsdescribedintheClinicalProgrammerUserManual,alwaysturnthe

externalTNSamplitudeto0µAwhenrepositioningalead,changingtheselected

electrodecombination,orattachingtheConnectorCabletotheexternalTNS.When

restartingstimulation,increasetheamplitudeSLOWLYuntilthedesiredparesthesiais

achieved.Failuretodosomayresultinuncomfortablemotoractivationorpainful

stimulation.

RemovingtheDeliverySystemComponents–PercutaneousLeadTrial

1. Beforeremovingthedeliverysystemcomponents,advancetheleadfurtherintothe

epiduralspacetocreateastrainrelief.

2. Slowlyremovethedeliverysheathbyfirstpullingbackthesheathneartheneedle.Always

holdforwardpressureontheLeadwhileretractingthedeliverysheathtopreventlead

migration.

3. Retractthestyletintotheneedlesothatitisretractedbeyondthetipofthesheath.

4. Turnthesheathawayfromtheopeningoftheforamenandpushouttheleadsothata

loopiscreatedintheepiduralspace.

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

WARNING:Failuretoputaloopintheepiduralspacemayresultinleadmigrationand

mayleadtoaproceduretorevisetheposition.

5. Removethesheathcompletelywhileholdingforwardpressureonthelead.

WARNING:Whenremovingthesheath,verifythatthesteeringwingisnomorethan90

degreesmisalignedwiththemarkontheneedle.Failuretodosomayresultindamage

tothesheath.Beforereinsertingsheath,verifythereisnodamagetothebendofthe

sheath.

6. Removetheneedlefollowingthesameprocedure.Itisrecommendedthatthedesired

paresthesiabere‐testedaftertheremovalofthedeliverysystemcomponentsbutbefore

thecompleteremovalofthestylet.WiththeexternalTNSamplitudesetto0µA,

reconnecttheConnectorCableasdescribedbefore.

WARNING:Ifthesheathhasbeenkinkedduringdelivery,slowlyretractthroughthe

needlewiththecurvefacingthesamedirectionasthebevel.Failuretodosocan

damageorcuttheleadorsheath.Ifresistanceisencountered,pulltheneedleoutofthe

epiduralspaceandthenremovethesheath.

WARNING:Donotuseexcessiveforceiftheleadneedstoberemoved.Excessiveforce

maycauseleadfracture.

7. RecordtheleadpositionwithbothanA/Pandlateralfluoroscopicviewforcomparisonof

thepositionattimeofclosuretoensurethattheleadhasnotmoved.Removethestylet

byholdingforwardpressureontheleadwhileretractingthestylet.

WARNING:Useextremecarewhenremovingtheleadstylet,thedeliverysheath,and

theneedle,toinsurethatthedistaltipoftheleadremainsinthedesiredlocation.

Removingeachiteminslowmovements,whileholdingtheremainingcomponentsin

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place,willassistthisprocess.



LeadAnchoring–PercutaneousLeadTrial

1. AfterplacingaTrialleadinitsfinalposition,itshouldbesecuredusingaleadanchoron

theskin.

2. CarefullyslidetheleadanchorovertheproximalendoftheTrialLeadandadvanceitto

thepuncturesite.Theshortendofthesutureanchormustbefacingtowardstheincision.

3. ApplysuturesaroundtheanchorandcinchontotheTrialLeadasshownbelow.Applyat

leasttwotiestothemainbodyandonetietotheleg.



WARNING:Donotsuturedirectlyontothelead,asthereisariskofdamagingthelead.

Failuretosecuretheleadtotheskin,orothertissue,mayresultinleadmigrationand/or

motoractivationorpainfulstimulation.

WARNING:Failuretocomplytotheanchoringtechniquemayresultinleadmigration

and/ormotoractivationorpainfulstimulation.

4. Applyanantibacterialagenttothepuncturesite,ifdesired

5. ReconnecttheconnectorcabletotheleadsandcoilanyexcessTrialLeadlengtharound

thedistalendoftheConnectorCable,foldagauzepadaroundtheblock,andapplyalarge

adhesivepatchovertheareacontainingtheTrialLead(s),puncturesiteandConnector

Cable.



6. VerifytheconnectionoftheConnectorCabletotheTrialLeadsandtheexternalTNSprior

todischargeofthepatient.

NeurostimulationTrial–PercutaneousLeadTrial

1. UsingtheClinicalProgrammer,programtheTNSwiththeneurostimulationtrial

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parameters.

NOTE:RefertotheTrialNeurostimulatorUserManualandClinicalProgrammerUserManual

forspecificinstructionsontheprogrammingofthesedevices.

RemovingTrialLead–PercutaneousLeadTrial

WARNING:AlwaysremovetheTrialLeadsbeforeimplantingtheImplantLeads,asthere

isariskofinfectionthatmaycausedeathiftheleadsarenotremoved.Alwayspractice

propersterilepracticeswhenimplantingleadsandimplantableneurostimulator.

ToremovetheTrialLead(s)fromapatient:

1. DisconnecttheConnectorCableconnectionforeachTrialLead.

2. RemoveanysuturesoranchorsecuringeachTrialLeadtothepatient’sskin.

3. SlowlyapplylighttensiontoeachTrialLeadandverifythattheleadisretractingfromthe

patient.

4. PlacetheusedTrialLead(s)intoadesignated“Biohazard”packageclearlylabeledwiththe

patient’sIDnumberandtheremovaldate.

5. SendTrialLead(s)backtoSpinalModulationforevaluationasinstructedbyclinical

personnel.

WARNING:DonotremoveaTrialLeadquickly,asthismayresultinleadbreakageand

unintentionalleadfragmentsbeingleftinthepatient.

WARNING:TakeproperprecautionswhenhandlingremovedTrialLeadcomponents.

TreatallusedTrialLeadsanddeliverycomponentsasa“biohazard”.

WARNING:DonotreuseanydevicefromtheTrialLeadKitorTrialAccessoriesKit.

RemovingtheDeliverySystemComponents–ImplantLeadTrialOnly

TheseinstructionspertainonlyafterplacingImplantLeadduringthetrialprocedure.After

placingaleadinitsfinalposition,usingthetechniquesdescribedabove,itshouldbesecured

usingaleadanchortothesupraspinousligamentorfasciaandthenconnectedtothe

externalizedleadextensions.

WARNING:Donotsuturedirectlyontothelead,asthereisariskofdamagingthelead.

Failuretosecuretheleadmayresultinleadmigrationanduncomfortablemotor

stimulationorpainfulstimulation.

PRECAUTION:Useextremecarewhenusingsharpinstrumentsorelectrocauteryaround

theleadtoavoiddamagingthelead.

1. Leavingtheneedleinplace,preparetheanchorsitebymakinganapproximatelya3‐7cm

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longitudinalincision,centeredontheneedletothedepthofthesupraspinousligament.

2. Establishhemostasisanduseretractorsforgoodvisualization.

3. Slowlyremovethedeliverysheathbyfirstpullingbackthesheathneartheneedle.Always

holdforwardpressureontheLeadwhileretractingthedeliverysheathtoprevent

movement.

4. Retractthestyletintotheneedlesothatitisretractedbeyondthetipofthesheath.

5. Turnthesheathawayfromtheopeningoftheforamenandpushouttheleadsothata

loopiscreatedintheepiduralspace.



WARNING:Failuretoputaloopintheepiduralspacemayresultinleadmigrationand

mayleadtoaproceduretorevisetheposition.

6. Removethesheathcompletelywhileholdingforwardpressureonthelead.

WARNING:Whenremovingthesheath,verifythatthesteeringwingisnomorethan90

degreesmisalignedwiththemarkontheneedle.Failuretodosomayresultindamage

tothesheath.



WARNING:Ifthesheathhasbeenkinkedduringdelivery,slowlyretractthroughthe

needlewiththecurvefacingthesamedirectionasthebevel.Ifresistanceis

encountered,pullouttheneedleandthenproceedtoremovethesheath.Failuretodo

socandamageorcuttheleadorsheath.

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7. Removetheneedlefollowingthesameprocedure.

8. Itisrecommendedthatthedesiredparesthesiabere‐testedaftertheremovalofthe

deliverysystemcomponentsbutbeforethecompleteremovalofthestylet.Withthe

externalTNSamplitudesetto0µA,reconnecttheConnectorCableasdescribedbefore.

WARNING:Donotuseexcessiveforceiftheleadneedstoberemoved.Excessiveforce

maycauseleadfracture.

9. RecordtheleadpositionwithbothanA/Pandlateralfluoroscopicviewforcomparisonof

thepositionattimeofclosuretoensurethattheleadhasnotmoved.Removethestylet

byholdingforwardpressureontheleadwhileretractingthestylet.

WARNING:Useextremecarewhenremovingtheleadstylet,thedeliverysheath,and

theneedle,toensurethatthedistaltipoftheleadremainsinthedesiredlocation.

Removingeachiteminslowmovements,whileholdingtheremainingcomponentsin

place,willassistthisprocess.

LeadAnchoring

Afterplacingaleadinitsfinalposition,itshouldbesecuredusingasofttissueanchorandthen

connectedtoexternalizedextensions.

WARNING:Donotsuturedirectlyontothelead,asthereisariskofdamagingthelead.

Failuretosecuretheleadtotheskin,orothertissue,mayresultinleadmigrationand

uncomfortablemusclestimulation.

PRECAUTION:Useextremecarewhenusingsharpinstrumentsorelectrocauteryaround

theleadtoavoiddamagingthelead.

1. Soaktheanchorinsterilewater(notsaline)tolubricateit.

2. Placetheanchorontheleadandslideitdownascloseaspossibletowherethelead

emergesfromthevertebralcolumn.Becarefulnottomovethelead.

NOTE:Ifimplantingmultipleleads,tagtheleadswithsuture(ligature)sothattheirposition

canbeidentifiedlater.

PRECAUTION:Observethesecautionswhenattachingthesofttissueanchorbecause

damagetotheanchororleadcanoccurandresultinfailureofthesystem:

• Donotusepolypropyleneormonofilamentsuture

• Donotplacesuturesdirectlyonthelead.

• Avoidsharpbendsorkinkingonthelead.

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3. Usingthe2‐0silknon‐absorbablesuture,tietwoligaturesaroundthecenteroftheanchor

tosecuretheanchortothelead.Ifneeded,makeminoradjustmentstotheleadposition.

Tieoneligaturearoundtheleganddonottietothesofttissue.Verifythattheshortend

oftheanchorentersintotheligament.



PRECAUTION:Failuretopushtheshortendofthesofttissueanchorintotheligamentor

fasciamayresultinleadmigrationandaproceduretorevisetheleadlocation.



4. Itisrecommendedthattheleadpositionisverifiedunderfluoroscopyanddesired

paresthesiabere‐testedafterfixation.WiththeexternalTNSamplitudesetto0µA,

reconnecttheConnectorCableasdescribedbefore.



PercutaneousExtensionTunneling–ImplantLeadTrialOnly

1. Identifythetunnelingroutebetweentheleadincisionandtheextensionexitsite.

2. Administeranestheticattheexitsiteandalongthetunnelingroute.

3. Assemblethetunnelingtoolpackagedwiththeleadbyslippingthepassingstrawoverthe

tunnelingrod,thenattachingthetunnelingtip.

4. Bendthetunnelingtoolasnecessarytoconformtothepatient’scontouralongthe

tunnelingroute.

5. Makeastabwoundattheexitsite.

6. Beginattheexitsiteandtunnelsubcutaneouslytotheleadincision

7. Guidethetunnelingtoolsubcutaneouslyalongthetunnelingroutebypushingtheskin

overtheadvancingtooltipuntilthetipandapproximately1cmofthepassingstraware

exposedattheleadincision.

8. Withdrawthetunnelingtoolleavingthepassingstrawinplaceinthetunnel.

9. Gentlyinserttheproximalendoftheextensionthroughthepassingstrawtotheexitsite.

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10. Slidethepassingstrawovertheextensionandoutoftheskinexitsite,leavingthe

extensioninplace.

11. Ifnotdonepreviously,usebluntdissectiontoaformasubcutaneouspocketoffthelead

incisionforthelead‐extensionconnection.

12. Wipetheleadandextensionconnectorjunctionwithsterilegauze.Ifnecessary,moisten

thegauzewithsterilewateroranonionicantibioticsolution.

13. Dryallconnections.Fluidintheconnectionmayresultinstimulationattheconnection

site,intermittentstimulation,orlossofstimulation.

14. Holdtheextensionconnectorstraightwhilefirmly,butgently,insertingtheleadintothe

connectoroneortwocontactsatatimeuntileachleadcontactisalignedundereach

extensionconnectorcontact.Duringinsertion,someresistanceistypicalbecausethe

internalsealsprovideelectricalisolation.

15. Verifythatthemarkontheleadalignswiththeendoftheextensionconnector.Thiswill

verifythattheleadisfullyinserted.

16. Usethetorquewrenchsuppliedinthepackagetotightenthesetscrew.Tightenuntila

clickisheard.Usingminimalforce,andwhilesecurelyholdingtheleadtoprevent

dislodgement,pullontheconnectiontoensurethatitissecure.

17. Usingminimalforce,pulltheextensionfromtheskinexitsite,feedingthelead‐extension

connectionintothelead‐extensionconnectionpocket.

18. Inordertoaidinidentificationofeachleadafterthetrialperiod,tieasuturelightlytothe

leadandanotheronetotheleadextension.Usedifferentcolorsutureandnumbersof

suturetoidentifytheleads.Thiswillaidinidentificationduringtheimplantprocedure.

19. Createstrainreliefloopsbycoilingexcessleadproximaltothesofttissueanchorinloops.

Insertthecoiledleadintothepocket,undertheconnection,leavingasmuchslackas

possibleintheleadbetweentheanchorandthelead‐extensionconnection.

20. Closetheincisionanddresstheincisionsite.

21. Attheexitsite,coilanyexcessextensionaroundthedistalendoftheConnectorCable,

foldagauzepadaroundtheblock,andapplyalargeadhesivepatchoverthearea

containingexitpuncture,excessextension,andConnectorCable.

RemovingLeadExtension–ImplantLeadTrialOnly

1. Removethebandageneartheexitpointoftheleadextension.

2. Pulltheleadextensionlightlyoutoftheincisionandcuttheleadextension.

3. Exposethelead‐extensiontoleadconnection.

4. Whilemaintainingleadposition,carefullyremovethelead‐extensionconnectionsfromthe

incision.

5. Disconnecttheleadfromtheextension.

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6. Cuttheextensionnearthelead‐extensionconnector.

7. Discardthelead‐extensionconnector.

8. Preservingsterility,pulltheextensionoutthroughtheskinexitsite.

9. Discardtheextension.

10. Ifmultipleextensionsareimplanted,repeattheremovalstepsfortheotherextensions.

CreatingtheINSPocket–Implant

Oncethelead(s)hasbeenanchored,aNeurostimulatorpocketshouldbecreatedandthelead

tunneledforconnectiontotheINS.

ThefollowingstepsoutlinethesuggestedproceduretocreateanINSpocket:

1. DeterminethesitefortheINS.Thisshouldbedonebeforeimplantingtheleadtoverify

thereisenoughlengthtoreachtheINSpocketandprovidestrainreliefinthepocket,near

theanchor,andintheepiduralspace.

NOTE:TheINSshouldbelocatedinanareathatthepatientcaneasilyreachwiththe

magnetand/orprogrammer:

• Intheupperbuttocksalongtheposterioraxillaryline(avoidingthebeltline)

• Justovertheabdomenbelowthelowestrib

2. Administerlocalanestheticattheneurostimulatorpocketsite.

3. UsebluntdissectiontocreateapocketsothattheINSisparalleltotheskinsurfaceandno

deeperthan2.0cmbelowtheskinsurface.Useelectrocauterytomaintainhemostasis.

4. (Optional)InserttheINSsizertoensurethepocketislargeenoughtoaccommodatethe

INS,allowingextraroomforastrainreliefloopforeachlead.



PRECAUTION:DonotimplanttheINSdeeperthan2.0cm,astheprogrammerwillnotbe

abletocommunicatewiththeINS.

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PRECAUTION:DonotapplyelectrocauterydirectlytotheINSasthiscandamagetheINS

orcauseinterferencewhilecommunicatingwiththeINS.

LeadorExtensionTunneling

TunneltheleadsfromtheanchorsitetotheINSpocket.Whentunnelingtotheabdomen,the

clinicianhastwooptions:

• TunneltoamidpointandthencontinuetoINSsite.

• Usethe51cmtunnelingtoolandcurvetheconduitaroundthesideofthepatient.



Thefollowingstepsoutlinethesuggestedproceduretotunnelfromtheleadanchorsitetothe

INSpocket:

PRECAUTION:Useextremecaretonotdamagetheleadwiththesharppointofthe

tunnelingtool.

1. Identifythetunnelingroutebetweentheleadincisionandtheneurostimulatorpocket.

2. Administerlocalanestheticalongthetunnelingroute.Additionalsedationmaybe

administeredatthediscretionofthephysician.

3. Bendthetunnelingtoolasnecessarytoconformtothepatient’scontouralongthe

tunnelingroute

4. Withthestrawinplaceonthetunnelingtool,tunnelfromtheINSpockettothelead

anchorsite.

5. Withdrawthetunnelingtoolfromthestraw,leavingthestrawinthesubcutaneous

tunnel.

PRECAUTION:LeadsorExtensionsshouldberoutedadjacenttooneanotherastoprevent

changesinperceivedstimulationfromtheftdetectorsandmetalscreeningdetectors.

6. PasstheendoftheLead(s)orExtension(s)throughthestrawfromtheanchorsitetothe

INSpocketortothemidpointiftunnelingtotheabdomen.Ateachincisionpoint,leave

astrainreliefloopinplaceastominimizethechancesofleadmigration.

7. Removethestrawfromthetunnelbypassingitovertheleads,takingcarenottocause

tractiononthemanddisturbtheleadposition.



ConnectingLeadtoExtension

IfanextensionisusedtoconnecttheLeadtotheINS,refertothesection“Percutaneous

ExtensionTunneling”forinstructionsonhowtoconnecttheExtensiontotheLead.

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ConnectingtheINS

ThefollowingstepsoutlinetheguidelinestoconnectingaLeadorExtensiontotheINS:

PRECAUTION:Donotconnectaleadwithbodyfluidonitscontactsbecausecorrosioncan

occurandcausefailureofthesystem.

PRECAUTION:IfthereisaneedtocommunicatewiththeINSpriortoimplantation,donot

puttheINSonastainlesssteeltable,ascommunicationmaybedifficult.Thismayprolong

theprocedure.

1. Iftheleadcontactscameincontactwithbodyfluidsorsaline,thoroughlycleanwith

steriledeionizedwaterorsterilewaterforirrigationandthendrythemcompletely.

2. Usingcleangloves,carefullyslidetheleadorextensionintotheINSheaderuntilthe

depthmarkeralignswiththeedgeoftheheader.

PRECAUTION:UseonlythetorquewrenchprovidedbySpinalModulationorthedeviceor

leadmaybedamagedandunusable.Tightenuntilaclickisheardortheleadmaymake

intermittentcontactwiththestimulator.

3. Insertthetorquewrenchthroughthesealplugandtightenthesetscrewbyturningit

clockwise,untilthewrenchclicks.



4. Carefullyremovethetorquewrenchandverifythattheseptumoverthesetscrewis

closed.Reseattheflapsifitisnotclosed.

5. Ifimplantinglessthan4leads,inserttheportplugsineachofthevacantheaderports.

Usethetorquewrenchtotightenthesetscrewontheportpluguntilitclicks.

PRECAUTION:InserttheleadslowlyintotheheadertopreventdamagetotheINS.Ifthe

leadneedstoberetracted,retracttheleadslowly.

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37

ImplantingtheINS

ThefollowingstepsoutlinetheprocedureforimplantingtheINS:

PRECAUTION:DonotimplanttheINSfacedown.Alwaysimplantwiththelabelfacingup.

Failuretodosowillpreventcommunicationwiththeprogrammerand/ormagnet.

PRECAUTION:IfusingmorethanINS,implantthematleast15cmapart.Puttingthemtoo

closetogethermayinterferewiththeprogrammer’sabilitytocommunicatewitheachone

separately.

1. PlacetheINSintothepocketatadepthnogreaterthan2cmfromtheskinsurface,with

thelabelfacingtheskinsurface.

2. CarefullycoilexcessleadbehindtheINSoraroundtheINSinloopstoprovidestrain

relieffortheleadandINSconnection.



PRECAUTION:CoilingtheleadonthetopsurfaceoftheINS(closesttotheskin)will

interferewiththeabilityoftheprogrammertocommunicatewiththedevice.

PRECAUTION:DonotbringthesutureneedleincontactwiththeINS,orleadduring

sewingtheINSintothepocketorclosingthepocket.Thecomponentsmaybedamageif

thisoccurs.

3. TostabilizetheINSwithinthepocket,passasuturethroughthetwosutureholesinthe

INSandsecureittoconnectivetissue.

4. Checktheentiresystembyfluoroscopypriortoclosingtoensureproperpositioningof

theleads.Verifythattheleadshavenosharpbendsorkinks.

5. PlacethemagnetintoasterilebagandwaveovertheINS.

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38

6. Slowlyawakenthepatientandtestforstimulationperceptionandtherebyverifyingthe

systemisoperational.

NOTE:TheINSoutputmaynotbeidenticaltothetrialneurostimulatoroutput.Alwaysstart

stimulatingfromasettinglowerthanthatusedtostimulatewiththetrialneurostimulator.

7. EnsurethatthattheINSisawayfromthepocketincisionsutureline,closethepocket

incision,andapplyappropriatedressings.

8. FilloutthepatientregistrationinformationformandreturnittoSpinalModulation.

CheckingSystemIntegrity

1. Placethemagnetinasterilepouchandwaveitoverthedeviceto

startprogrammercommunication.

2. Usingtheclinicalprogrammerinthenon‐sterilefield,program

thebasicstimulationparameters,checkthebatterystatus,and

checktheelectrodeimpedancestoensurethereisnoshortor

opencircuit.

3. Oncethesystem’sfunctionisverified,turntheneurostimulatoroff.

CompletingtheProcedure

1. Followstandardprocedureforwoundclosureandbandaging.

ReplacinganINS

ThefollowingstepsoutlinethesuggestedproceduretoreplaceanINS:

1. TurnofftheINSandverifythatithasbeenturnedoff.

PRECAUTION:Exercisecarewhenusingsharpinstrumentsorelectrocauteryaroundleads

ortheymightbedamaged.

2. OpentheINSimplantsitepernormalsurgicalprocedures.

3. RemovethesuturefromtheINSheader,withoutdamagingthelead,andcarefully

removetheINSfromthepocket.

4. CleantheINSheaderandtheleadwithsterilewaterandthenwipewithasurgical

sponge.

5. InsertthetorquewrenchthroughtheseptumoftheINSheaderandloosenthesetscrew

byturningitcounterclockwise.

PRECAUTION:Whenperformingthefollowingsteps,donotbendtheleadsharplyasthis

maycauseleadbreakage.

MagnetActivationTarget

Magnetmustbewithin3.5

cmofINSsurfacefor

activationof

communication.

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39

6. GentlyremovetheleadfromtheINSheader;thencleananddryallconnectionsonthe

lead,ensuringtheyarefreefromfluidandtissue.

PRECAUTION:Ifresistanceismetwhileremovingleadsfromtheepiduralspace,donot

useexcessiveforcetoextract.Alwaysperformremovalwiththepatientconsciousand

abletogivefeedback.

WARNING:Donotremovealeadquickly,asthismayresultinleadbreakageand

unintentionalleadfragmentsbeingleftinthepatient.

WARNING:Takeproperprecautionswhenhandlingremovedleadcomponents.Treatall

usedleadsanddeliverycomponentsasa“biohazard”.

7. Ifyouneedtoreplacealead,performthefollowingactions:

a. Makeanincisionabovethelocationofthesutureanchor.

b. Carefullycutthesuturesfromthesutureanchor.

c. Slidetheleadoutoftheepiduralspaceslowly.

8. TocompletetheINSreplacementprocedure,see“ConnectingtheLeadtotheINS”.

9. Tocompleteleadplacement,see“PlacingaLead”.

DisposingofanExplantedDevice

AllexplantedINSsshouldbereturnedtoSpinalModulationforproperdisposal.Todisposeof

anexplanteddevice,followthesesteps:

WARNING:Donotcrush,puncture,orburntheINSbecauseitmayexplodeorcatchon

fire.

1. Decontaminatetheexplanteddevice.

2. Placeitinacontainerwithabiohazardlabel.

3. Includeacompleted“ReturnedProductForm.”(OneispackagedwitheachnewINS)

4. Returntheexplanteddeviceto:

SpinalModulation

1135O’BrienDrive

MenloPark,CA94025

U.S.A.



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40

AppendixA:TrialLeadKit/ImplantLeadKit

HowSupplied

ThecomponentsoftheSpinalModulationTrialLeadKitandImplantLeadKitareprovided

sterileinadoublepouchassemblyandareintendedforsingleuseonly.Donotresterilizeor

reuseanydevicesfromtheLeadKits,foranyreason,becauseofriskofinfectiontothesubject

andmalfunctionofthedevices.

PRECAUTION:DonotresterilizetheLeadKitsoranyothersterilecomponentsasitwill

createariskofinfectionormalfunctionofthedevice.

StorageTemperature‐StoretheTrialLeadKitandLeadAccessoriesKitbetween14°F(‐10°C)

and122°F(50°C).Temperaturesoutsidethisrangemaydamagethecomponents.Ifa

temperaturedeviationhasoccurred,donotusetheproduct.

Sterilization‐TheTrialLeadKit,ConnectorCable,andallLeadKitAccessorieshavebeen

sterilizedusingethyleneoxide(EO)gas.

PackageContents

(1)Trial/ImplantLead50cm/90cm

(1)22cmSmallCurveDeliverySheath

(1)22cmBigCurveDeliverySheath

(1)Guidewire

(1)ComplexCurveStylet

(1)4.5”14GaugeNeedle

(2)SoftTissueAnchors

(1)PhysicianImplantManual

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41

DeviceSpecification

TheLeadhasfourelectrodesonthedistalendandtheproximalendfitsintoafourconductor

connectorontheConnectorCableorintotheINSports.TheComplexCurvedStylethasbeen

insertedintotheproximalendoftheleadandtheleadhasbeenpre‐loadedintoa22cmSmall

CurveDeliverySheathforuserconvenience.AnillustrationoftheTrialLeadisgiveninFigure1.



Figure1:Leadshowingfourproximalelectricalconnectorsandfourradiopaqueelectrodes

TheapproximatemeasurementsforaTrialLeadarepresentedbelow:

ProximalElectricalConnector..................Quadrapolar,in‐line

CentertoCenterConnectorSpacing ........3.3mm(0.130”)

Diameter ..................................................1.0mm(0.040”)

Length ......................................................50cm(20”)or90cm(35”)

NumberofElectrodes……………………........4

ElectrodeShape…………………………….........Cylindrical

ElectrodeLength ......................................1.25mm(0.050”)

EdgetoEdgeSpacing ...............................5mm(0.200”)

CentertoCenterSpacing.........................6.25mm(0.250”)

ArrayLength………………………………….........20mm(0.790”)

BallTipDiameter......................................1.5mm(0.060”)

StyletWireDiameter………………...............0.25mm(0.010”)

DCLeadImpedance(50cm/90cm/Extension)….<20Ω/<35Ω/<60Ω



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AppendixB:TrialNeurostimulator

DeviceDescription

SeetheTrialNeurostimulatorManualforthefulldescriptionofthedevice.TheexternalTrial

Neurostimulator(TNS)providesenergyandcontrolselectricalsignalsdeliveredtotheLeads.

TheTNSdeviceisintendedtobeconnectedtotheLeadsandwornbythesubjectforupto30

daysduringthestudyperiod.ThedeviceisintendedtobeconnectedtotheSpinalModulation

ConnectorCable.Itisnotcompatiblewithothercablesfromothermanufacturers.The

externalTNSdevicehasabeltclipthatcanbeusedorthesubjectmaychoosetouseaflexible,

elasticbandagetosecuretheirTNSdeviceduringthetrialperiod.Thepatientshouldbe

advisednottoallowtheTNStomakedirectcontactwithskin.



PackageContents

(1)TrialNeurostimulator

(1)TNSManual

DeviceSpecifications

SpecificationsRangeStepSizeDefaultValue

PulseAmplitude‐PA(µA)

(Dependingonmeasuredimpedance)

0–6000µA25µA:0‐2000µA

50µA:2000‐6000µA

0µA

MaximumPulseAmplitude‐Max(µA)

ProgrammablebyPatient

SameasPASameasPA0µA

PulseWidth–PW(µs)40–720µs10µs40µs

PulseFrequency‐PF(Hz)4–100Hz2Hz60Hz



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Handling

StorageConditions:‐10°C‐50°C

HumidityRange:10–93%

CleaningInstructionsforHealthcareProfessional:FordisinfectingtheTNSsurfacesaftergross

filthandheavysoilloadshavebeenremoved,sprayCavicideorequivalentontoapapertowel,

andthenwipethesurfaceoftheTNSwiththewetpapertowel.Allowthesurfacetoremain

dampfor2minutes.Drythesurfaceusingadrypapertowel.DonotimmersetheTNSin

liquid.AdvisethepatientnottocleantheTNSwithexcessiveliquid.Adampclothmaybeused

towipetheTNS,ifnecessary.

WARNING:AlwaysweartheTNSontheoutsideofclothingasthematerialmaycause

skinirritation.

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AppendixC:ImplantableNeurostimulator

HowSupplied

TheAxium™ImplantableNeurostimulatorisprovidedsterileinadoubletrayassemblyandis

intendedforsingleuseonly.Donotresterilizeorreuse,foranyreason,becauseofriskof

infectiontothepatientandmalfunctionofthedevices.

PRECAUTION:DonotresterilizetheINSasitwillcreateariskofinfectionormalfunction

ofthedevice.

DeviceDescription

TheImplantableNeurostimulatorisafourchannelneurostimulatorthatisonlycompatiblewith

SpinalModulationImplantLeadsandLeadExtensions.Ithasfourportstoallowforstimulation

ofuptofourleadssimultaneously.Ithasanantennaintheheaderthatallowswireless

communicationwiththedeviceusingtheSpinalModulationClinicalProgrammerorPatient

Programmer.

PackageContents

(1)ImplantableNeurostimulator

(3)LeadPortPlugs

(1)TorqueWrench

(1)SterileMagnetSleeve

(1)MedicalAlertCard

(1)ReferencetoImplantManual

DeviceSpecifications

OutputoftheINSisequivalenttotheoutputoftheTNS.Thedeviceisprogrammedincurrent,

impedanceismeasuredbythedevice,andtheappropriateoutputvoltagematchesthe

impedanceandcurrentprogrammed.

SpecificationsRangeStepSizeDefaultValue

PulseAmplitude‐PA(µA)

(Dependingonmeasuredimpedance)

0–6000µA25µA:0‐2000µA

50µA:2000‐6000µA

0µA

MaximumPulseAmplitude‐Max(µA)

ProgrammablebyPatient

SameasPASameasPA0µA

PulseWidth–PW(µs)40–720µs10µs40µs

PulseFrequency‐PF(Hz)4–100Hz2Hz60Hz



SpinalModulation,Inc. PhysicianImplantManual



45

TherapyAccuracy.....................................10%overtherangeof300to6000µA

ImpedanceMeasurementAccuracy ........5%overtherangeof400to2000Ohms

Height.......................................................6.52cm(2.57in)

Width .......................................................4.77cm(1.88in)

Thickness..................................................1.10cm(0.43in)

Volume.....................................................31cm3(1.89in3)

MaximumConnectorStrength ................10N

NumberofChannels ................................4

PowerSource ...........................................CFx,lithium‐carbonmonofluoride

StorageTemperature...............................‐10°C(14°F)to50°C(122°F)

StorageHumidity .....................................10%to90%



Handling

StorageConditions:‐10°C‐50°C

HumidityRange:10–90%

Handling:Beforeimplantation,onlywipewithsterilewateranddonotuseanycleaning

agents.

PRECAUTION:Beforeimplantation,donotusechemicalsoranycleaningagentstowipe

theINS.Thismaycauseirritationorinflammationattheimplantsite.



DeviceLongevity

Forinformationregardingdevicelongevity,contactSpinalModulation.



SpinalModulation,Inc. PhysicianImplantManual



46

TheAxium™NeurostimulatorSystemcomplieswiththefollowingInternationalStandards:

• IEC60601‐1:2005

• IEC60601‐1‐11:2010

• IEC60601‐1‐2:2007

• ISO14708‐1:2000

• ISO14708‐3:2008



CompanyandAuthorizedRepresentativeContactInformation



SpinalModulation,Inc.

1135O’BrienDrive

MenloPark,CA94025

U.S.A.

Telephone:(650)543‐6800(24‐hoursupportline)

Fax:(650)327‐2336

Email:clinicalsupport@spinalmodulation.com

HealthlinkEuropeB.V.

DeTweeling20‐22

‘sHertogenbosch5215MC

TheNetherlands

Telephone:+31135479300

Fax:+31135479301



AuthorizationtoaffixtheCEmarkgrantedin2011



Spinal Modulation orporated MN0200 Implantable Neurostimulator User Manual LP0275 Rev B September 2011

Spinal Modulation, Incorporated Implantable Neurostimulator LP0275 Rev B September 2011

Revised user manual

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