Product Info
Safety Information
WaveWriter Alpha™ & WaveWriter Alpha™ Prime Systems Information for Prescribers
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Handle the system external components and accessories with care. Do not drop them or submerge them
in water. Although reliability testing has been performed to ensure quality manufacturing and performance,
dropping the devices on hard surfaces or in water, or other rough handling, can permanently damage
these components. (See “Limited Warranty - IPG”.)
Upon completion of the Patient Trial, remove the batteries from the ETS.
Component Disposal. Do not dispose of the Remote Control or Charger in re. The battery in these
devices can explode in re. Dispose of used batteries in accordance with local regulations. The IPG should
be explanted in the case of cremation, and returned to Boston Scientic. External devices to be disposed
of per local regulatory requirements. Patients should contact their healthcare provider.
Remote Control, Charging System, and External Trial Stimulator Cleaning. The charging system
components can be cleaned using alcohol or a mild detergent applied with a cloth or tissue. The Remote
Control and ETS can be cleaned using a mild detergent applied with a lightly dampened cloth or tissue.
Residue from soapy detergents should be removed with a cloth lightly dampened with water. Do not use
abrasive cleansers for cleaning. Cleaning wipes for the External Trial Stimulator can also be ordered
through Boston Scientic customer service. As an operator of the external devices, perform only the
following service and maintenance tasks on the external devices:
• Changing the battery
• Charging the battery
• Cleaning
Ensure that the devices are not in use while performing service and maintenance tasks. Do not clean any
of the accessories while they are directly or indirectly connected to a power outlet.
Cell Phones. While we do not anticipate any interference with cell phones, the full effects of interaction
with cell phones are unknown at this time. Portable RF communications equipment (for example mobile
phones) should be kept a minimum distance of 6 inches (15 centimeters) from the area of the implanted
device. If there is a concern or a problem is encountered, the patients should contact their healthcare
provider.
Adverse Eects
Potential risks are involved with any surgery.
The possible risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation
include:
• Lead migration, resulting in undesirable changes in stimulation and subsequent reduction in pain relief.
• System failure, which can occur at any time due to random failure(s) of the components or the
battery. These events, which may include device failure, lead breakage, hardware malfunctions, loose
connections, electrical shorts or open circuits and lead insulation breaches, can result in ineffective
pain control.
• Tissue reaction to implanted materials can occur. In some cases, the formation of reactive tissue
around the lead in the epidural space can result in delayed onset of spinal cord compression and
neurological/sensory decit, including paralysis. Time to onset is variable, possibly ranging from weeks
to years after implant.
• Skin erosion at the IPG site can occur over time.
• Possible surgical procedural risks are: temporary pain at the implant site, infection, cerebrospinal uid
(CSF) leakage and, although rare, epidural hemorrhage, seroma, hematoma and paralysis.
• External sources of electromagnetic interference may cause the device to malfunction and affect
stimulation.