Dextrus 53, sn: (b)(6).Upon receipt, the lead under complaint was found cut 8 cm distal to the is-1 connector pin.The proximal and medial fragment were received for analysis.The distal fragment including the lead tip was not returned.An extraction aid was found on the medial fragment, it is reasonable to assume that the lead was cut during the surgery.The analysis showed that the medial fragment was found abraded through, which is assumed to be the root cause of the reported oversensing.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.Dextrus 60, sn: (b)(6).Upon receipt, the lead under complaint was found cut 7.5 cm and 11.5 cm distal to the is-1 connector pin.An extraction aid was found on the distal fragment, it is reasonable to assume that the lead was cut during the surgery.The analysis showed that the insulation was found abraded through between 14 cm and 10 cm proximal to the lead tip, which is assumed to be the root cause of the reported oversensing.The insulation damage probably resulted from severe mechanical stress due to constant friction against another implantable device such as a nearby lead.Significant lead motion in the area of the tricuspid valve and interaction with atypical tissues should also be taken into consideration.The quality documents accompanying the manufacturing process for these devices were re-investigated.All production steps were performed accordingly, and in particular the final acceptance tests proved the functions of the devices to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.
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