User's Manual
SpinalModulation,Inc. PhysicianImplantManual
i
Contents
ExplanationofSymbolsonProductorPackageLabeling................................................. 4
INTRODUCTION ............................................................................................................................ 5
SystemOverview ............................................................................................................ 6
IndicationsforUse .......................................................................................................... 7
Contraindications............................................................................................................ 7
SYSTEMDESCRIPTION.................................................................................................................... 7
TrialNeurostimulator(TNS) ............................................................................................ 9
ImplantableNeurostimulator(INS) ................................................................................. 9
ImplantLeads/TrialLeads/LeadExtension..................................................................10
ConnectorCableKit .......................................................................................................10
LeadAccessories ............................................................................................................10
ImplantationTools.........................................................................................................11
AdditionalAccessories ...................................................................................................11
ClinicalProgrammerandPatientProgrammer ...............................................................11
SterilizationInformation................................................................................................12
StorageConditions.........................................................................................................12
ProductMaterials ..........................................................................................................12
SAFETYINFORMATION ..................................................................................................................13
• GeneralWarnings .................................................................................................13
• Warnings–ForUseinHomeorWorkEnvironments.............................................15
• Precautions ...........................................................................................................16
AdverseEvents ..............................................................................................................17
I
MPLANTINGTHENEUROSTIMULATORSYSTEM ...................................................................................18
• PrecautionsfortheImplantProcedure .................................................................18
SelectionofNeurostimulatorTrialApproach .................................................................19
PreparingthePatientandDevicesforUse .....................................................................20
PlacingtheLead .............................................................................................................20
IntraoperativeTesting....................................................................................................25
RemovingtheDeliverySystemComponents–PercutaneousLeadTrial.........................26
LeadAnchoring–PercutaneousLeadTrial .....................................................................28
NeurostimulationTrial–PercutaneousLeadTrial...........................................................28
RemovingTrialLead–PercutaneousLead
Trial ..............................................................29
RemovingtheDeliverySystemComponents–ImplantLeadTrialOnly..........................29
LeadAnchoring ..............................................................................................................31