User's Manual

Risks Related to Stimulation
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Operation of the StimRouter components may cause increased pain in an area other
than the lead site. This pain may be caused by stimulation of the tissue surrounding
the stimulation electrodes (e.g., skin, fascia and muscle).
Patients may also experience an undesirable motor response during stimulation.
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If patients experience any pain or discomfort during stimulation, or notice any skin abnormalities,
they should stop stimulation immediately, remove the StimRouter electrode and contact their
clinician.
Additional Risks Related to the StimRouter System
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Migration of the lead may cause changes in stimulation effectiveness.
While very unlikely, a tissue reaction to any of the implanted materials may occur.
External electromagnetic interference may cause the StimRouter components to
malfunction and may affect stimulation.
Patients may experience persistent pain at the implant site of the lead.
Although rare, the skin overlying the lead may erode.
Portable and mobile radio frequency communications equipment can affect medical
electrical equipment.
The StimRouter external components could overheat if the components fail, which
could cause burning.
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If patients experience any pain or discomfort during stimulation, or notice any skin abnormalities,
they should stop stimulation immediately, cease contact with the StimRouter components and
notify their clinician.
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Clinician’s Guide