Information for Patients
• 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 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 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.
• Undesirable stimulation may occur over time due to cellular changes in tissue around the
electrodes, changes in electrode position, loose electrical connections and/or lead failure.
• You may experience painful electrical stimulation of your chest wall as a result of stimulation of
certain nerve roots several weeks after surgery.
Precision Novi™ System Information for Patients
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