Upon receipt, the lead under complaint was found severely fragmented.An extraction aid was found in the lead body.The proximal fragment (including the connector) and the distal fragment (including the lead tip) were not returned for analysis.Due to the severely fragmented state of the lead the definite root cause of the reported loss of capture could not be determined.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.
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