Upon receipt, the lead under complaint was found capped 52cm proximal to the lead tip.The distal fragment was received for analysis.The proximal fragment was not returned.An extraction aid was found in the lead body.The performance of the lead fragment was scrutinized, including a visual inspection.The analysis revealed cuts into the insulation 30cm proximal to the lead tip and a deformed lead body from 48cm to 50cm proximal to the lead tip, which most likely resulted from the extraction procedure.However, a thorough analysis of the returned lead fragment did not show any deviations which might have led to the reported complaint description.The manufacturing processes for both leads (sn:48925607/48925685) were 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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