The explanted generator was returned to 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.
A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.
The battery, 2.
690 volts as measured during completion of test parameter 7.
16.
10.
2 (measured diagvbat) of the final electrical test, shows an ifi condition.
The data in the diagaccum consumed memory locations revealed that 107.
632% of the battery had been consumed.
There were no performance or any other type of adverse conditions found with the pulse generator.
However, a review of the internal memory locations within the generator suggests the existence of an error in calculating the device's total consumed energy.
This error results in an incorrect device longevity estimate.
Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.
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