User Manual

Safety Information

Warnings

Magnetic Resonance Image (MRI). Patients implanted with the

Precision SCS system should not be subjected to MRI. MRI exposure

may result in dislodgement of implanted components, heating of the

neurostimulator, damage to the device electronics and/or voltage

induction through the leads and stimulator causing an uncomfortable

or “jolting” sensation.

Pediatric Use. The safety and effectiveness of spinal cord stimula-

tion has not been established for pediatric use.

Diathermy. Shortwave, microwave and/or therapeutic ultrasound

diathermy should not be used on SCS patients. The energy generated

by diathermy can be transferred through the stimulator system, caus-

ing tissue damage at the lead site which may result in severe injury or

death. The IPG, whether it is turned on or off, may be damaged.

Implanted Stimulation Devices. Spinal cord stimulators may

interfere with the operation of implanted sensing stimulators such as

pacemakers or cardioverter defibrillators. The effects of implanted

stimulation devices on neurostimulators is unknown.

Implant Damage. Burns may result if the pulse generator case is

ruptured or pierced and patient tissue is exposed to battery chemicals.

Do not implant the device if the case is damaged.

Postural Changes. Patients should be advised that changes in pos-

ture or abrupt movements may cause decreases, or uncomfortable or

painful increases in the perceived stimulation level. Patients should be

advised to turn down the amplitude or turn off the IPG before making

posture changes. If unpleasant sensations occur, the IPG should be

turned off immediately.