Date of event is estimated.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Related manufacturer report number: 3006705815-2021-00350, 3006705815-2021-00557, 3006705815-2021-00558, 1627487-2021-01174.It was reported the patient was experiencing pain and swelling at the ipg site that radiated to the opposite side of the back.Patient also reported a fever with sweats.The physician stated the patient had cellulitis at the ipg and lead incision sites.As a result, the patient underwent surgical intervention during which the system was explanted with no complications.
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