Boston Scientific Precision Montage MRI Informacion Para Medicos página 6

Information for Prescribers
Magnetic Resonance Imaging (MRI).
• The Precision Montage MRI Spinal Cord Stimulator (SCS) System is "MR Conditional".
An MRI examination can be conducted safely using only a 1.5 Tesla horizontal closed-
bore whole-body MRI system for the MRI scan when all instructions in the supplemental
manual "ImageReady™ MRI Full Body Guidelines for Precision Montage MRI Spinal Cord
Stimulator System" are followed. The 1.5T MRI system can be configured to use the Full
Body, Head, and Extremity transmit/receive RF quadrature coils, and receive only coils of
any type. 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 Precision
Montage MRI SCS System. The "ImageReady™ MRI Full Body Guidelines for Precision
Montage MRI Spinal Cord Stimulator System" manual appears on the Boston Scientific
websites (www.bostonscientific.com/MRI and www.bostonscientific.com/ImageReady). MRI
examinations performed on patients with the Precision Montage MRI 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: 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.
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.
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.
Important: If unpleasant sensations occur, the IPG should be turned off immediately.
Precision Montage™ MRI System Information for Prescribers
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