User's Manual
SpinalModulation,Inc. PhysicianImplantManual
13
SafetyInformation
GeneralWarnings
ThefollowingwarningsapplytotheuseoftheAxium™NeurostimulatorSystem:
• External Defibrillators – Safetyfor use ofexternal defibrillatordischarges on a patient
receivingneurostimulationhasnotbeenestablished.
• Magnetic Resonance Imaging – The patient should be advised to not undergo any
electivemagneticresonanceimaging(MRI)withthesysteminplace.UseofMRIinthe
vicinityofthelead(s)mayresultinforceful dislodgmentofthelead(s),ordamagetothe
Neurostimulator. If a voltage is induced through the lead, it may cause uncomfortable
(“jolting”or“shocking”)levelsofstimulationorinjurytothepatient.
• UltrasonicScanning–Ultrasonicequipmentmaycausemechanicaldamagetothelead
ifuseddirectlyoverthesite.
• ElectrosurgeryDevices–Electrosurgerydevicesshouldnotbeusedincloseproximityto
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.
• PediatricUse–Useofneurostimulationhasnotbeenapprovedspecificallyforchildren
lessthan18yearsofage.
• Pregnancy–Safetyandeffectivenessofneurosti mulationforuseduringpregnancyand
nursinghavenotbeenestablished.
• Non‐EmergencyProcedures–Thepatientmustbeadvisedthattheymustnothavenon‐
emergencyprocedureswhiletheyareundergoingtrialstimulation.
• EmergencyProcedures–Thepatientshouldbeinstructedtodesignatearepresentative
(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,
defibrillationorcardioversion.
• 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
proceduresmayprovideinterferencethat
canaffectTNSorINSdeviceoperationoruse
ordamagecomponentsofthesystemthatmaycausepatientharm.