User's Manual
SpinalModulation,Inc. PhysicianImplantManual
17
• 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
(spongebathsareacceptable as long as the TNSdevice does notget wet).The patient
mustbeinstructednottodropormishandletheir TNSdevice.Physicaldamagetothe
unitmayimpairitsfunction.ThepatientmustbeinstructedtonotopentheTNScase.
• Lead and Cable Care – The patient must be instructed to not remove their lead(s) or
ConnectorCableduringthetrialperiod.Manipulationofthecomponentsmayresultin
the patient developing an infection, getting undesirable stimulation, or accidentally
turningtheirstimulationoff.
• 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
mustbeinstructedtonotdiscardorburntheirTNSdevice.Firemaycausetheinternal
batterytoexplode.
• TNSBattery Replacement– It isunlikely that the battery willneedreplacementinthe
shorttime that thepatient has their TNSdevice.However,if the TNS device doesnot
function the patient must not try toopen the TNS case.The internal battery must be
replacedbySpinalModulationpersonnelonly.Thepatientshouldbeadvisedtocontact
theirphysicianduringregularbusinesshours.
• MaterialSensitivity–Hypersensitivity(rednessintheareaofskincontact)canhappen
ifthepatienthasanallergicreactiontothematerials.Ifthisoccurs,thepatientshould
beinstructedtocontacttheirphysicianduringregulatorbusinesshours.
AdverseEvents
Theimplantation ofa neurostimulation systeminvolvesrisk.In addition tothose risks
commonly associated with surgery, the following risks are also associated with
implantationanduseoftheAxium™NeurostimulatorSystem:
• Pain(wheretheneedlehasbeeninserted)
• Pain(causedbyunderstimulationduetoleadmigration)
• Painovertheimplantableneurostimulatorsite
• Escalatingpain
• Bleeding(wheretheneedlehasbeeninserted)
• Headache
• Infection
• Localizedcollectionofserous(clear)fluidatinjectionsite
• Discomfortduringthetreatment
• Allergicorrejectionresponsetoimplantmaterials
• Constantpainattheleadsite
• Stimulationofthechestwall
• Leadmigration(movement)and/orlocalskinbreakage