It was reported that the patient was referred for a prophylactic vns generator replacement surgery.During the replacement surgery, the surgeon inadvertently cut the lead and a full revision had to be performed.The generator and lead were returned to the manufacturer for evaluation.The majority of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The set screw 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.Note that since the majority of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.The generator performed according to functional specifications.No eri flags were observed during testing.There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.It was later reported approximately nine years later via social media comment by the patient¿s mother that the patient experienced vocal cord paralysis following the generator replacement surgery in which the surgeon inadvertently cut the lead and had to perform a full replacement surgery.It was stated that the patient was not able to make any sound and it took almost a year for the patient to be able to talk well.The mother also reported that the device could not be programmed on for almost two years and then had to be adjusted very slowly.Review of the manufacturer's programming history database revealed that the diagnostics were within normal limits for the approximately seven years present in the database.No additional relevant information has been received to date.
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