Adverse Effects; Instructions For The Physician - Boston Scientific WaveWriter Alpha Informacion Para Medicos

Storage, Handling and Transport. Do not expose the Remote Control or Charging System components to excessively hot or cold conditions. Do
not leave the devices in your car or outdoors for extended periods of time. The sensitive electronics can be damaged by temperature extremes,
particularly high heat.
If the Remote Control or the Charging System is to be stored for a period of time without batteries, the storage temperature should not exceed
-20 to 60 °C (-4 to 140 °F).
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 fire. The battery in these devices can explode in fire. Dispose of used
batteries in accordance with local regulations. The IPG should be explanted in the case of cremation, and returned to Boston Scientific. 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. 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 healthcare provider.

Adverse Effects

Potential risks are involved with any surgery.
The possible risks of implanting a pulse generator as part of a system to deliver 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 magnetic resonance imaging (MRI) can result in discomfort or injury due to heat near the Stimulator or the leads, tugging or vibration
of the implanted system, induced stimulation, damage to the device requiring its replacement and may distort the image needed for diagnosis.
• Undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose
electrical connections and/or Lead failure.
• The patient may experience painful electrical stimulation of the chest wall as a result of stimulation of certain nerve roots several weeks after
surgery.
• Over time, the Stimulator may move from its original position.
• Weakness, clumsiness, numbness or pain below the level of implantation.
• Persistent pain at the IPG or Lead site.
In any event, instruct the patient to contact their healthcare provider to inform him/her.

Instructions for the Physician

Implanted Stimulation Devices. If such implanted devices are indicated for the patient, careful screening is required to determine if safe results can
be achieved before permanently implementing concurrent electrical therapies.
Postural Changes. Depending on the activity level of the patient, postural changes may affect stimulation intensity. Instruct patients to keep the
Remote Control on hand at all times, and ensure that they understand how to adjust stimulation levels. Refer to Postural Changes in the Instructions
for Patients section of this manual, page 1, for additional information. If using therapy that does not produce a sensation, postural changes are
less likely to affect the patient.
Medical Devices/Therapies. If the patient is required to undergo lithotripsy, electrocautery, external defibrillation, radiation therapy, ultrasonic
scanning, or high-output ultrasound, X-ray or CT scan:
• Turn off stimulation at least five minutes before the procedure or application.
• All equipment, including ground plates and paddles, must be used as far away as possible from the IPG and all external devices (for example, the
ETS, Remote Control, OR cables, and Charger).
• Every effort should be taken to keep fields, including current, radiation, or high-output ultrasonic beams, away from the IPG and all external
devices.
• Equipment should be set to the lowest energy setting clinically indicated.
• Instruct patients to confirm IPG functionality following treatment by turning on the IPG and gradually increasing stimulation to the desired level.
Wavewriter Alpha™ & WaveWriter Alpha™ Prime System Information for Prescribers
Safety Information
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