A large portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.The abraded opening and slice mark 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 inside the outer silicone tubing.For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device.In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.The pulse generator performed according to functional specifications (final configuration r-wave test).The pulse generator did show signs of premature battery depletion.This is reported in mfr.Report # 1644487-2018-01493.
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