Document Reference: ENG-UMAN-000730
Revision: 6.00
Page 11 of 40
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CLS migration, which may result in pain or difficulty in charging.
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Seroma or hematoma at surgery sites.
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Epidural hemorrhage, spinal cord injury and possible paralysis.
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Lead migration from the location chosen at initial implantation resulting in
stimulation changes.
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Breakage of the lead or failure of other system components, which may result in loss
of stimulation.
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Rejection of, or allergic reaction to, the implanted components.
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Infection that may require hospitalization with intravenous antibiotic therapy.
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Cerebrospinal fluid (CSF) leakage.
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Inadequate pain relief following system implantation.
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Erosion of the lead, or CLS through the skin.
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Weakness, clumsiness, numbness or pain below the level of lead implantation.
The patient may require surgery (including revision, explant and replacement) as a result of
any of the above.
