The explanted products were received on (b)(4) 2015 for analysis.In the pa lab, the generator output signal was monitored for more than 24-hrs, while the 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 battery, 3.036 volts, shows an ifi=no condition.There were no performance or any other type of adverse conditions found with the pulse generator.Analysis on the lead is underway but has not been completed to date.
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Analysis was completed on the returned portion of the lead.A majority 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.There appeared to be white deposits observed in various locations, which contained silicon, phosphorus, sodium, magnesium and calcium.The condition of the returned lead portion is 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 portion were performed, during the visual analysis, and no discontinuities were identified.Based on the findings , there is no evidence to suggest an anomaly with the returned portion of the device.
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