Warnings, Limitations, And Risks; Warnings; Limitations - Boston Scientific Spectra WaveWriter Mode D'emploi

Warnings, Limitations, and Risks

Warnings, Limitations, and Risks

Warnings

Do not use with RF Body Transmit 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 also damage the IPG electronics, potentially requiring device
replacement.
Do not use with Receive-only Head Coil or Surface Coils: Ensure that the head coil being used is not
a receive only head coil and the scanner settings are set to use the head coil only. Receive-only head coils
are not part of an Eligible 1.5T MRI Head Coil Setup, as defined in this manual, because these require the
use of a RF body coil to transmit.
Only use 1.5T transmit/receive RF quadrature head coils: Do not use other transmit/receive coils
(eg, linear coils). Only 1.5T transmit/receive quadrature head coils have been evaluated.
MRI Exposure: MRI fields may potentially interact with implanted Spinal Cord Stimulation Systems to
cause tugging (moving) sensation of implanted components, warming of the neurostimulator, damage
to the device electronics and/or voltage induction through the Leads and Stimulator causing unintended
stimulation, which the patient could experience as a tingling, shocking, or jolting sensation. Therefore, it is
very important to follow the instructions in this manual to minimize the potential interactions with MRI. Refer
to the section in this manual titled "Risks and Potential Interactions" for additional information.
External Devices: Spectra WaveWriter SCS System external components (such as 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 room.

Limitations

• If the patient has any other active or passive medical implant from a manufacturer that prohibits or
contraindicates an MRI examination, follow the instructions from the manufacturer. The instructions
in this manual apply only to the Spectra WaveWriter SCS System with ImageReady MRI Technology
described herein.
• Physicians should not prescribe MRI for patients undergoing trial neurostimulation and/or having
systems that are not fully implanted.
ImageReady MRI Guidelines for Spectra WaveWriter Spinal Cord Stimulator System
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