User Manual

Safety Instructions

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.

• Possible surgical procedural risks are: infection, cere-

brospinal fluid (CSF) leakage and, although rare, epidu-

ral hemorrhage, seroma, hematoma, and paralysis.

• External sources of electromagnetic interference may

cause the device to malfunction and affect stimulation.

• Exposure to MRI can result in heating of tissue, image

artifacts, induced voltages in the neurostimulator and/or

leads, lead dislodgement.