It was reported that patient experienced a cerebrospinal fluid (csf) leak during permanent implant procedure while the physician was attempting to place one lead.As a result, the procedure was abandoned.A blood patch was required, and patient was later given iv fluids administered with tylenol.Patient did not report any symptoms.
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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: drg slim tip lead, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 8860742.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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