Boston Scientific Precision Novi Manual Del Usuario página 10

Information for Prescribers
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 the following:
• Lead migration, resulting in undesirable changes in stimulation and subsequent reduction in
pain relief.
• System failure, which can occur at any time due to random 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. In some cases, the formation of reactive
tissue around the lead in the epidural space can result in delayed onset of spinal cord
compression and neurological/sensory deficit, including paralysis. Time to onset is variable,
possibly ranging from weeks to years after implant.
• 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.
• 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.
• The patient may experience painful electrical stimulation of the chest wall as a result of
stimulation of certain nerve roots several weeks after surgery.
• Over time, the Stimulator may move from its original position.
• Weakness, clumsiness, numbness or pain below the level of implantation.
• Persistent pain at the IPG or lead site.
In any event, instruct the patient to contact their physician to inform him/her.
Precision Novi™ System Information for Prescribers
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