Related manufacturer reference number: 1627487-2022-01490, related manufacturer reference number:1627487-2022-01491.It was reported during a system explant procedure lead fragmentation on the l1 and s4 leads occurred, leaving fragments inside the patient.The procedure was completed without removing the fragments and there is no intervention anticipated to remove the fragments.
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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 event could not be conclusively determined.During processing of this complaint, attempts were made to obtain complete device, patient and event information.
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