It was reported that the patient's generator was explanted due to the device hurting them and not wanting it anymore.Product analysis was completed on the returned lead and generator.For the lead, the anchor tether helical and a small portion of quadfilar coil, and the (+) white and (-) green electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.The condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure.No 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.For the generator, the septum was not cored.The device's output signal was monitored for more than 24-hours in a simulated body temperature environment.Results showed no signs of variation in the generator's output signal and demonstrated the expected level of output current during the monitoring period.Diagnostics were as expected for the generator and an automated electric evaluations showed the generator performed according to functional specifications.No additional relevant information has been received to date.
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