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 and 43 cm distal to the is4 connector pin that the conductor coil was found fractured, which is assumed to be the root cause of the clinical observations.Based on the characteristics, as well as the location of the fracture, it is reasonable to assume that the lead was subject to excessive mechanical forces as the result of clavicular-first rib entrapment.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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