It was originally reported that the patient was experiencing pain in the neck at the site of the electrodes and in the chest at the site of the generator.The generator was programmed off on (b)(6) 2015.It was reported that the patient underwent surgery to replace the generator on (b)(6) 2015.Pre-operation diagnostic results were checked on the original generator and lead and the results were within normal range.Once the new generator was attached to the original lead, diagnostics were checked and impedance was above normal range.The pin of the original lead was reinserted into the generator and during this process the lead broke.The broken lead is reported under mfr.Report # 1644487-2015-04830.It was noted by the surgeons that the original placement of the lead was not well done and seemed "tight" (no slack) before the lead finally broke.Due to the lead break, a full revision was performed and diagnostics were run and the results were within acceptable ranges.The generator and lead have not been received to date.
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