User's Manual

Information for Prescribers
Precision Spectra™ System Information for Prescribers
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Rainov, N.G., V. Heidecke, and W. Burkert. “Short Test-Period Spinal CordStimulation for Failed
Back Surgery Syndrome.” Minim Invasive Neurosurg, 39(2):41-44, 1996.
Segal, R., B. Stacey, T. Rudy, S. Basser, J. Markham. “Spinal Cord Stimulation Revisited.”
Neurological Research, 20:391-396, 1998.
Spieglemann, R. and W.A. Friedman. “Spinal Cord Stimulation: A Contemporary Series.”
Neurosurg 28:65-71, 1991.
Villavicencio, A.T., J.C. Leveque, L. Rubin, K. Bulsara, and J.P. Gorecki. “Laminectomy versus
percutaneous electrode placement for spinal cord stimulation.” Neurosurgery, 46:399-406,
2000.
Contraindications
Patients contraindicated for permanent Spinal Cord Stimulation (SCS) therapy are those who:
• are unable to operate the SCS system
• have failed trial stimulation by failing to receive effective pain relief
• are poor surgical risks
• are pregnant
Safety Information
WARNING: Unauthorized modifi cation to the medical devices is prohibited. System integrity
could be compromised and harm or injury to the patient could occur if the medical devices are
subjected to unauthorized modifi cation.
Instructions for the Patient
Warnings
Heat Due to Charging. 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, as shown, may result in a
burn. If patients experience pain or discomfort, they should cease charging and contact Boston
Scientifi c.
Magnetic Resonance Imaging (MRI). Patients implanted with the Precision Spectra SCS
system should not be subjected to MRI. MRI exposure may result in dislodgement of implanted
components, heating of the neurostimulator, damage to the device electronics and/or voltage
induction through the leads and Stimulator causing an uncomfortable or “jolting” sensation.