A generator was explanted and returned due to normal battery depletion.Analysis was performed on the device and it was identified that a supply current parameter measurement was over the upper limit and did not meet the electrical specification.This measurement demonstrated an increased current consumption for the device and could have potentially contributed to an end of the battery life.Analysis confirmed that an electrical component of the device was the root cause of this excessive leakage current.The reason for the component¿s increase in leakage current could not be determined.After the faulty component was substituted, the generator module performed according to functional specifications.Although the device appears to have depleted within expected timeframes based upon the battery life estimation and programming history and clinical history, the faulty capacitor identified during product analysis suggests that it may have also contributed to the battery depletion.
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