Product Info
Information for Prescribers
WaveWriter Alpha™ & WaveWriter Alpha™ Prime Systems Information for Prescribers
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Instructions for the Patient
Warnings
Heat Due to Charging (for rechargeable IPGs). Patients should not charge while sleeping. This may
result in a burn. While charging, the Charger may become warm. It should be handled with care. Failure
to use the Charger with either the Charging Belt or an adhesive patch, may result in a burn. If patients
experience pain or discomfort, they should cease charging and contact Boston Scientic.
Magnetic Resonance Imaging (MRI).
• The WaveWriter Alpha and WaveWriter Alpha Prime SCS Systems are “MR Conditional”. An MRI
examination can be conducted safely only when using a 1.5 Tesla horizontal closed-bore whole-body
MRI system for the MRI scan and following all instructions in the supplemental manual “ImageReady™
MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord
Stimulator Systems”. The 1.5T MRI system can be congured 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 the supplemental manual in its entirety before conducting or recommending
an MRI examination on a patient with a WaveWriter Alpha or WaveWriter Alpha Prime SCS System.
The “ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™
Prime Spinal Cord Stimulator Systems” manual appears on the Boston Scientic websites (www.
bostonscientic.com/ImageReady and www.bostonscientic-elabeling.com). MRI examinations
performed on patients with the WaveWriter Alpha or WaveWriter Alpha Prime SCS System using open-
sided MRI systems, or other types of MRI systems operating at other static magnetic eld strengths
(higher or lower), have not been assessed and, as such, should not be performed.
• External Devices: External components (for example, the ETS, Remote Control, and 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 stimulation has not been established for pediatric use.
Diathermy. Shortwave, microwave and/ or therapeutic ultrasound diathermy should not be used on SCS
patients with a stimulator. 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. Stimulators may interfere with the operation of implanted sensing
stimulators such as pacemakers or cardioverter debrillators. 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. If using therapy
that does not produce a sensation (subperception), postural changes are less likely to affect the patient.
Important: If unpleasant sensations occur, the IPG should be turned off immediately.
Electromagnetic Interference. Strong electromagnetic elds can potentially turn stimulation off, cause
temporary unpredictable changes in stimulation, or interfere with Remote Control communication. If an
electromagnetic eld is strong enough to turn stimulation off, this will be temporary and stimulation will
automatically return once the electromagnetic eld is removed. Patients should be advised to avoid or
exercise care around the following: