User Guide

Patient Trial Handbook 48
• System failure, which can occur at any time due to random failure(s) of the
components or the battery. These events, which may include battery leakage, device failure, lead 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 fluid surrounding your spinal cord, there is a small risk that spinal fluid 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 brain hemorrhage or paralysis. Your spinal cord may become compressed.
• External sources of electromagnetic interference may cause the device to
malfunction and affect stimulation.