It was reported that during surgery for high impedance on (b)(6) 2014 (mfr.Report # 1644487-2014-01301), a new generator was connected to the lead which resulted in device diagnostics within normal limits (impedance value 3470 ohms).It was determined that the prior high impedance measurement was due to a lead pin insertion issue, so the existing lead was left in place.The next day, (b)(6) 2014, the patient's device was programmed on.System diagnostics were run, and the impedance was 2764 ohms.The patient was seen for follow-up on (b)(6) 2014.System diagnostics were performed, and the impedance was greater than 10,000ohms.It was advised that a likely intermittent lead fracture existed and the lead should be replaced.No known surgical intervention has been performed to date.No additional relevant information has been received to date.
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