Boston Scientific Precision Novi Guia De Informacion página 6

Information for Prescribers
Instructions for the Patient
Warnings
Magnetic Resonance Imaging (MRI)
Patients implanted with the Precision Novi SCS system should not be subjected to MRI. MRI
exposure may result in tissue damage, 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. Precision Novi external
components (i.e. Remote Control) should not be exposed to MRI. The Precision Novi System
has not been evaluated for safety and compatibility in the MR environment. The Precision Novi
System components have not been tested for heating or migration in the MR environment.
Introducing a patient with this device into an MRI scanner may result in severe patient injury,
death, or device malfunction.
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 Novi™ System Information for Prescribers
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