Related manufacturer report number: 1627487-2022-03537, 1627487-2022-03539.It was reported that the patient loss therapy due to high impedances on both leads.It was noted that the patient had a fall.As a result, the patient underwent surgical intervention to address the issue.During the procedure, it was noted that one of the anchors had broken into 2 pieces.In turn, the leads and anchor were explanted and replaced.Effective therapy was established post-operatively.
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Date of event is estimated.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The allegation is against 1 of 2 anchors; however, it is unknown which anchor, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: swift-lock anchor, model: 1192ans, udi: (b)(4), batch: 6714560.
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