Safety Information
Clinician Manual
97035873-01 9 of 75
Safety Information
Instructions for the Patient
Warnings
Heat Due to Charging. Do not charge while sleeping. This may result in a burn. While charging, the Charger
may become warm. It should be handled with care. Failure to use the Charger with either the Charging Belt
or an adhesive patch, as shown, may result in a burn. If you experience pain or discomfort, cease charging
and contact Boston Scientic.
Magnetic Resonance Imaging (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 stimulation 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, causing
tissue damage at the lead site and resulting 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 debrillators. The effects of implanted stimulation
devices on neurostimulators is unknown.
Stimulator 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 posture 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. If using therapy that does not produce a
sensation (subperception), postural changes are less likely to affect the patient.
Electromagnetic Interference. Strong electromagnetic elds can potentially turn the Stimulator off, cause
temporary unpredictable changes in stimulation, or interfere with the Remote Control communication.
Patients should be counseled to avoid or exercise care around the following:
• Theft detectors, tag deactivators and RFID devices, such as those used at department stores,
libraries, and other public establishments. The patient should proceed with caution, ensuring to move
through the center of the detector as quickly as possible.
• Security screeners, such as those used in Airport Security or at entrances to government buildings,
including hand-held scanners. The patient should request assistance to bypass the device. If the
patient must pass through the security screener, they should move quickly through the device staying
as far from the physical device as allowable.
• Power lines or power generators.
• Electric steel furnaces and arc welders.
• Large magnetized stereo speakers.
• Strong magnets.
• Automobiles or other motorized vehicles using a LoJack system or other anti-theft systems that can
broadcast a radio frequency (RF) signal. The high energy elds produced by these systems may
interfere with the operation of the Remote Control and its ability to control stimulation.
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