User Manual

Safety Instructions

Adverse Effects

Potential risks are involved with any surgery. The possible risks of

implanting a pulse generator as part of a system to deliver spinal cord

stimulation include:

• Lead migration, resulting in undesirable changes in

stimulation and subsequent reduction in pain relief.

• System failure, which can occur at any time due to ran-

dom failure(s) of the components or the battery. These

events, which may include device failure, lead breakage,

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.

• Skin erosion at the IPG site can occur over time.

• Possible surgical procedural risks are: temporary pain at

the implant site, infection, cerebrospinal fluid (CSF)

leakage and, although rare, epidural 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.