Additional components potentially involved in the event include: common device name: drg slim tip lead, model: mn10450-50, udi: (b)(4), serial: (b)(6), batch: 7333911.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.
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It was reported that during a lead revision procedure on (b)(6) 2024 [related manufacturer reference number: 1627487-2024-07795 and 1627487-2024-07796], one of the leads fractured and a portion of the lead remains implanted.As a result, surgical intervention may be undertaken to address the issue.It is unknown which lead remains implanted.
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