safety information
External Devices: Boston Scientific external components (i.e., External Trial Stimulator and OR
Cable, Remote Control and Accessories, Battery Charger) are MR Unsafe. They must not be taken
into any MR environment such as the MRI scanner room.
Pediatric Use. The safety and effectiveness of spinal cord stimulation has not been established for
pediatric use.
Diathermy. As an SCS patient, you should not have any form of diathermy either as 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 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 spinal cord stimulator before going forward with other implantable
device therapies so that medical decisions can be made and appropriate safety measures taken.
Implant Damage. Burns may result if the pulse generator case is ruptured or pierced and patient
tissue is exposed to battery chemicals.
Precision montage™ mri system information for Patients
91053248-04 reV a
5 of 679