It was reported that during a procedure [related manufacturer report number: 3006705815-2023-07821] on (b)(6) 2023, the physician accidentally cut the patient's lead.As a result, the lead was explanted and replaced to address the issue.It is unknown which lead was accidentally cut by the physician.
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Date of event is estimated.Information requested, but not yet received.The allegation is against 1 of 2 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: scs octrode lead, model: 3186, udi: (b)(6) , serial: (b)(6), batch: a000053403.
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During processing of this incident, attempts were made to obtain complete event and patient information.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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