The explanted lead was returned for analysis on (b)(4) 2015.Product analysis for the lead was completed and approved on (b)(4) 2015.An analysis was performed on the returned lead portions and a condition was observed that could potentially contribute to the reported ¿low impedance / low impedance message, short circuit condition¿ (lead section) allegations.The bare and exposed conductive coils may be a contributing factor.Note that since a portion of the lead assembly including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Abraded openings were observed on the outer silicone tubing and both of the inner silicone tubes.The quadfilar coils appeared to be stretched, kinked and bare, in some areas.The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing.What appeared to be white deposits were observed in various locations.With the exception of the abraded openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure.No other obvious anomalies were noted.The setscrew 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 discontinuities were identified.
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