Upon receipt, the lead under complaint was subjected to an extensive analysis.The performance of the lead was scrutinized, including a visual, mechanical and electrical inspection.The analysis showed 41 cm distal to the is4 connector pin that the conductor coil was found fractured, which is assumed to be the root cause of the observed high pacing impedance and oversensing.This damage most likely resulted from a tight suture sleeve.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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