Boston Scientific Neuromodulation Corporation SC5132 Manual De Usuario
Information for Prescribers
Precision Spectra™ System Information for Prescribers
90668515-01 Rev A 10 of 15
90668515-01 Rev A 10 of 15
Remote Control, Charging System, External Trial Stimulator and Wand Cleaning. The
charging system components can be cleaned using alcohol or a mild detergent applied with a
cloth or tissue. The Remote Control, External Trial Stimulator and Programming Wand can be
cleaned using a mild detergent applied with a lightly dampened cloth or tissue. Residue from
soapy detergents should be removed with a cloth lightly dampened with water. Do not use
abrasive cleansers for cleaning. Cleaning wipes for the External Trial Stimulator can also be
ordered through Boston Scientifi c customer service.
Cell Phones. While we do not anticipate any interference with cell phones, the full effects
of interaction with cell phones are unknown at this time. If there is a concern or a problem is
encountered, the patients should contact their physician.
charging system components can be cleaned using alcohol or a mild detergent applied with a
cloth or tissue. The Remote Control, External Trial Stimulator and Programming Wand can be
cleaned using a mild detergent applied with a lightly dampened cloth or tissue. Residue from
soapy detergents should be removed with a cloth lightly dampened with water. Do not use
abrasive cleansers for cleaning. Cleaning wipes for the External Trial Stimulator can also be
ordered through Boston Scientifi c customer service.
Cell Phones. While we do not anticipate any interference with cell phones, the full effects
of interaction with cell phones are unknown at this time. If there is a concern or a problem is
encountered, the patients should contact their physician.
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
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 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.
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,
• Skin erosion at the IPG site can occur over time.
• Possible surgical procedural risks are: temporary pain at the implant site, infection,
cerebrospinal fl uid (CSF) leakage and, although rare, epidural hemorrhage, seroma,
hematoma and paralysis.
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.
• 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.