Date of event is estimated.Additional components potentially involved in the event include: common device name: scs octrode lead, model: 3186, udi: (b)(4), serial: (b)(6), batch: a000138949.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 patient experienced ineffective therapy, patients lead had high impedances.As a result, surgical intervention was undertaken on 16 april 2024 wherein lead was explanted and replaced to address the issue.The investigation was unable to determine the lead that associated with the issue.
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