User's Manual
SpinalModulation,Inc. PhysicianImplantManual
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• Weakness
• Clumsiness
• Numbness
• Temporarymuscleactivation
Veryrarerisksandsideeffectsinclude:
• CerebralSpinalFluid(CSF)leakage
• Tissuedamage
• Nervedamage
• Spinalcordcompression
• Paralysis
• Hematoma
• Swelling
• Seroma
• Sensoryloss
• SkinerosionaroundtheINSorleads
• Batteryfailureand/orbatteryleakage
• Leadbreakagerequiringreplacementofthelead
• Hardwaremalfunctionrequiringreplacementoftheneurostimulator
• Painfromanon‐injuriousstimulustotheskin(allodynia)
• Anexaggeratedsenseofpain(hyperesthesia)
Additionalriskstothesubjects,asaresultoftheplacementandstimulationoftheleadinthe
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
neurostimulatorandactivated.Theneurostimulatoriscontrolledbyatrainedoperatorandthe
starting point for the stimulation will be set to the lowest available settings.Additionally, all
subjectswillbeawakeandconversantduring the procedure to minimize thelikelihoodof any
nervedamage.
ImplantingtheNeurostimulatorSystem
PrecautionsfortheImplantProcedure
• All implanting physicians should be experienced in the diagnosis and treatment of
chronicpainsyndromesandhaveundergonesurgicalanddeviceimplantationtraining.
• Donotbend,kink,or stretchtheleadbody, sheaths, orother components as thismay
resultindamagetothecomponentandpoorfunction.
• Donot insert the sheathintotheepidural space withouttheleadinserted,as thismay
causeinjurytothedura.Theleadcannotbeinsertedintothesheathwiththe sheathin
theepiduralspace.