It was reported that the patient was scheduled to have the vns removed.Investigation determined that the removal was due to the patient experiencing pain and tenderness under her arm.The explanted generator was later received by the manufacturer.The device 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 device performed according to functional specifications, and analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.No additional or relevant information has been received to date.
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