This event was previously reported on remedial action exemption approval (b)(4)inadvertently within 30 days of awareness on january 31, 2015.Analysis was completed on a prophylactically replaced generator.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, 2.864 volts as measured during completion of the final electrical test, shows an ifi=no condition.However, a review of the internal memory locations within the generator verified the existence of an error in calculating the device's battery voltage.Other than the noted event, there were no performance or any other type of adverse conditions found with the pulse generator.The error in calculating the device¿s battery voltage has been previously investigated, and it was determined that due to the presence of a manufacturing test system software issue and the near end of life condition of the relay utilized during the voltage measurement calibration of a small subset of demipulse generator printed circuit board assemblies, the generator was inaccurately calibrated to measure battery voltage during the production of the device.
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