It was reported through letter received that lead was explanted due to lead break.The explanted lead was washed, disinfected and was sent the manufacturer.The physician requested to analyze the lead to check the suspected fracture of lead.It was reported that this lead was implanted in (b)(6) 2008.The returned explanted lead was received by the manufacturer for the analysis; it was no possible to identify the model and serial number due to the partial lead return.The analysis was completed and this confirmed the discontinuity of both positive and negative coils in the electrode region of the returned lead portions; an abraded inner tubing opening near the coil break was observed.Abraded opening was also found on the outer silicone tubing and the cut ends that were made during the explanted process.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting on the coil surface during the testing.
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