Date of event is estimated.During processing of this complaint, attempts were made to obtain weight but not received.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 reference number 1627487-2021-00149.It was reported the patient developed radiculopathy due to the lead placement.In turn, the patient underwent surgical intervention wherein one of the leads was explanted and replaced.It is unknown which lead is related to the issue.Therefore, all the suspected leads are being reported.
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