The pulse generator was explanted/returned due to "prophylactic replacement." although the reported allegations of "increased seizures" and "painful stimulation" cannot be evaluated in the pa laboratory setting, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified.In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.This was successfully verified in the pa lab.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 generatoroutput signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The reported allegation of "low battery" was not duplicated in the pa lab.The battery, 2.818 volts, shows an ifi=no condition.There were no performance or any other type of adverse conditions found with the pulse generator.
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