Analysis was approved for the explanted lead on (b)(6) 2017.The coil of the connector ring appeared to be broken in several locations along the lead.Microscopy identified the break to show evidence of a stress induced fracture with mechanical damage due to fatigue, pitting, and a stress induced fracture due to rotational forces.Mechanical damage in some places prevented the fracture type from being identified.Abraded openings were observed on the outer and inner silicone tubes in several locations that likely contributed to the dried fluid remnants found inside the lead insulation.The set screw marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.No additional relevant information has been received to date.
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