User Manual

6
Physician Lead Manual
device electronics and/or voltage induction through the leads and
stimulator causing an uncomfortable or “jolting” sensation.
Medical Devices/Therapies. The following medical therapies or
procedures may turn stimulation off or may cause permanent damage
to the implant, particularly if used in close proximity to the device:
• lithotripsy
• electrocautery
• external defibrillation
• radiation therapy
• ultrasonic scanning
• high-output ultrasound
If any of the above is required by medical necessity, refer to “Instruc-
tions for the Physician” on page 8. Ultimately, however, the device
may need to be explanted as a result of associated failure.
Automobiles and Other Equipment. Patients should not operate
automobiles, other motorized vehicles, or potentially dangerous
machinery/equipment with therapeutic stimulation turned on. Stimu-
lation must be turned off first. Sudden stimulation changes, if they
occur, may distract patients from attentive operation of the vehicle or
equipment.
Adverse Effects
Potential risks are involved with any surgery. In addition to those typ-
ically associated with surgery, possible risks of stimulation system
implantation include:
• Lead migration, resulting in undesirable changes in
stimulation and subsequent reduction in pain relief.
• System failure, which can occur at any time due to ran-
dom failure(s) of the components or the battery. These
events, which may include device failure, lead breakage,