Advanced Neuromodulation Systems Inc. dba. St. Jude Medical Neuromodulation Division 001 Manuel D’Utilisation
Genesis Programmer User’s Guide
5
High Output Ultrasonics and Lithotripsy — The use of high output devices such as an
electrohydraulic lithotriptor may cause damage to the electronic circuitry of an implanted IPG. If
lithotripsy must be used, do not focus the energy near the IPG.
electrohydraulic lithotriptor may cause damage to the electronic circuitry of an implanted IPG. If
lithotripsy must be used, do not focus the energy near the IPG.
Ultrasonic Scanning Equipment — The use of ultrasonic scanning equipment may cause mechanical
damage to an implanted neurostimulation system if used directly over the implanted device.
damage to an implanted neurostimulation system if used directly over the implanted device.
External Defibrillators — The safety of discharge of an external defibrillator on patients with
implanted neurostimulation systems has not been established.
implanted neurostimulation systems has not been established.
Therapeutic Radiation — Therapeutic radiation may damage the electronic circuitry of an
implanted neurostimulation system, although no testing has been done and no definite information
on radiation effects is available. Sources of therapeutic radiation include therapeutic x-rays, cobalt
machines, and linear accelerators. If radiation therapy is required the area over the implanted IPG
should be shielded with lead.
implanted neurostimulation system, although no testing has been done and no definite information
on radiation effects is available. Sources of therapeutic radiation include therapeutic x-rays, cobalt
machines, and linear accelerators. If radiation therapy is required the area over the implanted IPG
should be shielded with lead.
A
DVERSE
E
FFECTS
The implantation of a neurostimulation system involves risk. In addition to those risks commonly
associated with surgery, the following risks are also associated with implantation, and/or use of a
neurostimulation system:
associated with surgery, the following risks are also associated with implantation, and/or use of a
neurostimulation system:
●
Undesirable changes in stimulation may occur over time. These changes in stimulation are
possibly related to cellular changes in tissue around the electrodes, changes in the electrode
position, loose electrical connections and/or lead failure.
possibly related to cellular changes in tissue around the electrodes, changes in the electrode
position, loose electrical connections and/or lead failure.
●
Placement of a lead in the epidural space is a surgical procedure that may expose the patient
to risks of epidural hemorrhage, hematoma, infection, spinal cord compression, and/or
paralysis.
to risks of epidural hemorrhage, hematoma, infection, spinal cord compression, and/or
paralysis.
●
Stimulation at high outputs may cause unpleasant sensations or motor disturbances
(including movement). If unpleasant sensations occur, turn the IPG off immediately.
(including movement). If unpleasant sensations occur, turn the IPG off immediately.
●
Battery failure and/or battery leakage may occur.
●
Radicular chest wall stimulation.
●
CSF leakage.
●
Persistent pain at the electrode or IPG site.
●
Seroma at the implant site.
●
Lead migration, which can result in changes in stimulation and subsequent reduction in pain
relief.
relief.
●
Allergic or rejection response to implant materials.
●
Implant migration and/or local skin erosion.
●
Paralysis, weakness, clumsiness, numbness or pain below the level of implantation.
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