Related manufacturer reference number: 3006705815-2021-01839.Related manufacturer reference number: 3006705815-2021-01840.Related manufacturer reference number: 1627487-2021-13293.It was reported that following a permanent implant procedure on (b)(6) 2021, the lead incision was open and not healing.As a result, surgical intervention was undertaken on (b)(6) 2021 wherein the entire system was explanted.
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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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