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.In the course of the analysis, the is4 connector was found damaged confirming the intraoperative observation reported in the complaint description.The silicone part was detached from the proximal part of the connector.Based on the characteristics of the damage, mechanical forces during the procedure should be taken into consideration.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.
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