Related manufacturer reference number 3006705815-2021-06477.Related manufacturer reference number 3006705815-2021-06478.Related manufacturer reference number 1627487-2021-19242.It was reported that patient experienced pain at the lead and anchor sites after a fall.Reportedly, the lead had migrated.As a result, surgical intervention was undertaken wherein one of the lead was explanted and replaced and both anchors explanted.The issue was resolved.It¿s unknown which lead was explanted and replaced, and both are being reported.
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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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