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 insulation was found abraded through between 50 cm and 52 cm distal to the is-1 connector pin, which is assumed to be the root cause of the clinical observations.Based on the characteristics of the damage, it is reasonable to assume that the lead was subject to severe mechanical stress due to constant friction against another implantable device such as a nearby lead.Furthermore, the fixation helix was found bent, which most likely resulted from the extraction procedure.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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