Boston Scientific Spectra WaveWriter Informacion Para Medicos página 11

• 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 physician 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 3, 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.
Spectra Wavewriter™ System Information for Prescribers
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Safety Information
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