The initial mdr indicated that device evaluation was not necessary as reported event(s) were not related to the functionality or delivery of therapy of the device.After the lead was returned and analyzed, a malfunction was found.This lead malfunction may have contributed the reported event as the cause of the reported event was not determined.Therefore, adverse event or product problem, corrected data: follow-up report #1 inadvertently did not include product problem suspect medical device, corrected data: follow-up report #1 inadvertently did not change the suspect device to the lead from the generator.Device code-event problem codes , corrected data: follow-up report #1 inadvertently did not include 1250, fluid leaks as a code.Type of reportable event, corrected data: follow-up report #1 inadvertently did not select 'malfunction' if follow-up what type?, corrected data: follow-up report #1 inadvertently did not select "device evaluation" device evaluated by mfr?, corrected data: follow-up report #1 inadvertently did not select "yes".
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Further information was received that product analysis was completed on the generator.Other than typical explant procedure related observations, no surface abnormalities were noted on the generator.An open can measurement of the battery voltage determined that the battery was depleted.The generator was unable to be interrogated due to this depleted battery condition.The generator performed according to functional specifications.Product analysis was also completed on the returned lead.A section of the lead assembly was returned for analysis in one piece, but the lead's electrodes were not returned for evaluation.Set screw marks were seen on the connector pin providing evidence that proper contact between the set screw and the connector pin existed at least once.Abrasions were noted on the connector boot.Abrasions were noted on the outer silicone tubing at multiple locations.The outer silicone tubing had a compressed appearance at multiple locations.The outer silicone tubing had what appeared to be internal abrasions at multiple locations.Abrasions most likely caused by the presence of a tie-down were noted.The inner silicone tubing of the lead coils is abraded open.The lead assembly had dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.No anomalies or discontinuities were found.An evaluation could not be made on the portion that was not returned.No further relevant information has been received to date.
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