Product analysis was completed on the returned generator.Visual examination showed only observations consistent with the explant process; no surface abnormalities were noted.The unit had failed to interrogate at 1 inch, but successfully interrogated at 0 inch spacing.The bench interrogation showed the generator was disabled from the battery voltage being at end of service (eos) levels.The generator pulse current would not reset.With the generator case removed and the battery still attached to the printed circuit board, the battery measured 1.641 volts, confirming an eos condition.Contaminants were observed on the edge of the circuit board.The internal device data showed 33.504% of the battery had been consumed.With the battery removed, electrical testing on the circuit board showed that the several electrical current tests had failed.With the use of fine grit sandpaper and isopropyl alcohol to remove observed contaminates from the trimmed edge of the circuit board, these previously failed tests subsequently passed.Product analysis concluded that the remaining residual material on the printed circuit board edge after the test tab was removed in the manufacturing process resulted in increased current consumption and likely contributed to the premature eos condition.Information from the available programming history and internal device data during the use life of the generator was consistent with these observations.No additional pertinent information has been received to date.
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