User's Manual

Information for Patients
Precision Spectra™ System Information for Patients
90668560-01 Rev B 18 of 32
breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and
lead insulation breaches, can result in ineffective pain control.
• Your body may react negatively to the materials used to manufacture the Stimulator or the
leads. You may notice redness, warmth or swelling of the implant area.
• The skin over your implant may become thin and increasingly tender over time. A seroma
may be formed.
• The most common surgical procedural risks are temporary pain at the implant site and
infection. However, since the leads are placed in the epidural space, there is a small risk
that spinal fl uid may leak from the lead insertion site following surgery. Very rarely, you
may develop an internal blood clot (hematoma) or blister (seroma); or you may experience
epidural hemorrhage or paralysis. Your spinal cord may become compressed.
• External sources of electromagnetic interference may cause the device to malfunction and
affect stimulation.
• MRI. Exposure to magnetic resonance imaging (MRI) can result in noticeable heat near the
Stimulator or the leads; may distort or destroy the image needed for diagnosis; and may
produce enough electromagnetic interference (EMI) to erase the Stimulator programming,
destroy the leads, or cause the leads to move from their intended location.