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 that the wires of the conductor coil leading to all the ring electrodes were found fractured 35.5 cm distal to the is4 connector pin, which is assume to be the root cause of the reported high pacing impedance.The fracture in this area was consistent with a crushing type of movement.Due to the location and type of damage, analysis determined it was likely caused by entrapment in the clavicle first-rib region.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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