It was reported that the patient passed away from an unknown reason.It was reported that the device was explanted and would be sent to manufacturer for analysis.The medical examiner indicated that the patient's vagus nerve was explanted with the lead attached to avoid damaging the lead electrodes.The relationship between vns and the death is known.The generator and lead were returned for analysis.The reason for explant was reported as sudden unexpected death with recent history of myocardial infarct (non-ischemic) and possible arrhythmia.The generator analysis was completed on (b)(6) 2014.The device performed according to functional specifications.Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.The lead analysis was completed on (b)(6) 2014.The slice marks found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes.The marks appeared to have been made by a sharp object which could have occurred during the explant procedure, however this cannot be confirmed.During the visual analysis the (+) white and (-) green electrodes appeared to be embedded in what appeared to be remnants of dried body tissue.This condition may have prevented the (+) white and (-) green electrode ribbons from coming in contact with the vagus nerve.With the exception of the observed tissue-covered (+) white and (-) green electrodes the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified.Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device.
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