Adverse Effects - Boston Scientific Spectra WaveWriter Informacion Para Medicos

Information for Prescribers
Remote Control, Charging System, External Trial Stimulator and Wand Cleaning. The
charging system components can be cleaned using alcohol or a mild detergent applied with a
cloth or tissue. The Remote Control, External Trial Stimulator and Programming Wand 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. Do not clean any of the accessories while they are directly or
indirectly connected to a power outlet.
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.
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. If there is a concern or a problem is
encountered, the patients should contact their physician.

Adverse Effects

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 deficit, 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 fluid (CSF) leakage and, although rare, epidural hemorrhage, seroma,
hematoma and paralysis.
• External sources of electromagnetic disturbance may cause the device to malfunction and
affect stimulation.
• Exposure to MRI can result in heating of tissue, image artifacts, induced voltages in the
neurostimulator and/or Leads, Lead dislodgement.
Spectra Wavewriter™ System Information for Prescribers
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