We were notified that there were also increasing thresholds on this lead.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 visual analysis revealed cuts into the insulation, which most likely resulted from the explantation procedure.However, a thorough analysis of the lead did not show any deviations which might have led to the clinical observation.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.
|