The patient underwent generator and lead replacement due to high impedance.The generator was replaced prophylactically.There was no obviously lead break observed at the time of explant; however, the surgeon did not look for one.The lead was cut in multiple pieces during the explant process.The explanted lead and generator were received for analysis.Analysis is underway, but has not been completed to date.
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Analysis of the generator was completed on 12/01/2015.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.Analysis of the lead was completed on 12/04/2015.A break was identified in the positive coil.Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the break location.However, due to metal dissolution, mechanical distortion (smoothed surfaces), and/or surface contamination.The fracture mechanism cannot be ascertained.Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
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