It was reported that during generator replacement surgery, high impedance was observed and the patient underwent both generator and lead replacement.Only the explanted generator was returned for analysis.Analysis of generator was completed.The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation.The device performed according to functional specifications.Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.The physician's office reported that the physician would not remember any further information; therefore, no additional relevant information was able to be obtained.
|