Product analysis was completed on the returned generator.The electrical tests performed in the pa lab found that the generator was at an neos = yes condition.The battery voltage was measured at 2.321 volts, and the memory locations on the generator indicated that 109.122% of the battery had been consumed.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.The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator, due to the pulse generator remaining ¿on¿ post explant.Review of the ram/flash data downloaded from the pulse generator shows an indication of post explant increased impedance; the ¿diagvinitialprechange¿ value of 1916 ohms, the ¿diagvinitialpostchange¿ value of 13297 ohms, and the time of change detection 01/11/2022 (explant date ((b)(6)2022).Therefore, the electrical performance of the generator, as measured in the pa lab, will be used to conclude that no anomalies exist, and the near-end-of-service (neos) condition is an expected event.Other than the noted event (pulsedisabled ¿vboost¿ compliance voltage), there were no additional performance, or any other type of adverse conditions found with the pulse generator.
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B5 describe event or problem, corrected data: supplemental report #02 report inadvertently left out relevant information h3 device evaluated by mfr?, corrected data: supplemental report #02 report inadvertently marked 'no' instead of 'yes' h6 adverse event problem codes, corrected data: supplemental report #02 report inadvertently left blank.
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