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 reference number: 1627487-2021-00257.It was reported the patient¿s lead had moved under the skin.In turn, surgical intervention was undertaken on (b)(6) 2020 wherein the physician opened the lead incision, pushed the lead deeper and secured it in place.This addressed the issue.It is unknown which lead had moved and revised, therefore both leads are being reported.
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