Adverse Effects
The use of a neurostimulation system involves risks. In
addition to those risks commonly associated with
surgery, the following risks are also associated with use
of a neurostimulation system:
▪
Unpleasant sensations or motor disturbances,
▪
including involuntary movement, caused by
stimulation at high outputs (if either occurs, turn off
stimulation immediately)
▪
Undesirable changes in stimulation, which may be
▪
related to cellular changes in tissue around the
electrodes, changes in electrode position, loose
electrical connections, or lead failure or breakage
▪
Stimulation in unwanted places (such as stimulation
▪
of the chest wall)
▪
Lead migration, causing changes in stimulation or
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reduced pain relief
▪
Epidural hemorrhage, hematoma, infection, spinal
▪
cord compression, or paralysis from placement of a
lead in the epidural space
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Cerebrospinal fluid (CSF) leakage
▪
▪
Tissue damage or nerve damage
▪
▪
Paralysis, weakness, clumsiness, numbness, sensory
▪
loss, or pain below the level of the implant
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Pain or bleeding where the needle was inserted
▪
▪
Persistent pain at the electrode or IPG site
▪
▪
Escalating pain
▪
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