Boston Scientific Spectra WaveWriter Informacion Para Medicos página 6

Information for Prescribers
in a burn. If patients experience pain or discomfort, they should cease charging and contact
Boston Scientific.
Magnetic Resonance Imaging (MRI).
• MRI Transmit or Transmit/Receive RF Body Coil: Patients implanted with the Spectra
WaveWriter SCS System should not be subjected to a MRI transmit or transmit/receive RF
body coil. RF body coil exposure may result in significant heating and/or tissue damage,
especially near the proximal and distal portions of the implant. RF body coil exposure can
damage the IPG electronics, potentially requiring device replacement. RF body coil
exposure may also cause voltage induction through the Leads and stimulator causing
unintended stimulation, which the patient could experience as a tingling, shocking, or jolting
sensation.
• MRI Transmit/Receive RF Head Coil: The Spectra WaveWriter SCS System is
"MR Conditional". An MRI examination of the head only (no other part of the body) can be
conducted safely using only a 1.5 Tesla horizontal closed-bore whole-body MRI system that
is configured to use its 1.5T transmit/receive radio frequency (RF) head coil for the MRI
scan when all instructions in the supplemental manual "ImageReady™ MRI Guidelines
for Spectra WaveWriter Spinal Cord Stimulator System" are followed. It is important to
read the information in this supplemental manual in its entirety before conducting or
recommending an MRI examination on a patient with a Spectra WaveWriter SCS System.
The "ImageReady™ MRI Guidelines for Spectra WaveWriter Spinal Cord Stimulator System"
manual appears on the Boston Scientific websites (www.bostonscientific.com and
www.bostonscientific-elabeling.com). MRI examinations performed on patients with the
Spectra WaveWriter SCS System using open-sided MRI systems, or other types of MRI
systems operating at other static magnetic field strengths (higher or lower) have not been
assessed and, as such, should not be performed.
• External Devices: Spectra WaveWriter external components (for example, the External
Trial Stimulator, Remote Control, Battery Charger) are MR Unsafe. They must not be taken
into any MR environment such as the MRI scanner.
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 defibrillators. The effects of
implanted stimulation devices on neurostimulators is unknown.
Spectra Wavewriter™ System Information for Prescribers
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