Boston Scientific SC-5210 Manuel page 9

NOTE: MRI Transmit/Receive RF Head Coil is not approved for use with Peripheral Nerve Stimulation.
Pediatric Use. The safety and effectiveness of spinal cord stimulation or peripheral nerve stimulation has not been established for
pediatric use.
Diathermy. As an SCS or PNS patient, you should not have any form of diathermy as either treatment for a medical condition or as
part of a surgical procedure. The high energy and heat generated by diathermy can be transferred through your stimulator system,
causing tissue damage at the lead site and, possibly, severe injury or death. The Stimulator, whether it is turned on or off, may be
damaged.
Cardiac Pacemakers. Spinal cord stimulators or peripheral nerve stimulators may interfere with the operation of implanted sensing
stimulators, such as pacemakers and implantable cardiac defibrillators (ICDs). Be sure your physicians are aware of your stimulator
before going forward with other implantable device therapies so that medical decisions can be made and appropriate safety measures
taken.
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.
Posture. Changes in posture or abrupt movements may cause decreases, or uncomfortable or painful increases in the perceived
stimulation level. Keep the Remote Control with you at all times, and turn the stimulation down or off before making posture changes.
If unpleasant sensations occur, the stimulation should be turned off immediately.
Electromagnetic Interference. Strong electromagnetic fields can potentially turn the stimulator off, or cause uncomfortable or jolting
stimulation. Avoid or exercise care around:
• Theft detectors or security screeners, such as those used at entrances/exits of department stores, libraries, and other
public establishments, and/or airport security screening devices. It is recommended that you request assistance to
bypass the device. If you must proceed through the device, turn off the stimulator and proceed with caution, and move
through the center of the screener as quickly as possible.
• Power lines or power generators
• Electric steel furnaces and arc welders
• Large magnetized stereo speakers
As you approach these devices you may become aware of changing stimulation levels. In rare instances, you could experience an
increase in stimulation level to the point that the sensation is uncomfortably strong or possibly "jolting." If this happens, turn off the
Stimulator. If the Stimulator suddenly turns off by itself, first move away from the area. Next, check the Stimulator status with the
Remote Control by pressing the Stimulation On/Off button and observing the screen. The Stimulator may need to be recharged before
stimulation can be restarted. (See "Charging the Stimulator" on page 29 for additional information.)
Safety Information
Patient System Handbook
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