On 02/25/2015 product analysis was competed on the generator.The generator was found to be at end of service and was determined to be the result of normal battery depletion.Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an end-of-service condition.A battery life estimation resulted in 3.00 years remaining before the eri flag would be set.However, an incomplete programming history (8.5-year gap) indicates the estimation does not use all the data required to make an accurate estimation.Therefore, the electrical performance of the generator, as measured in the product analysis lab, will be used to conclude that no anomalies exist and the eos condition is an expected event.The pulse generator module performed according to functional specifications; there was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.Product analysis on the lead was completed on 03/04/2015.Which confirmed discontinuity of the positive quadfilar coil in the body region of the returned lead portions; also observed abraded openings of the inner tubing near the break location.A break was identified in the positive coil at two locations.Scanning electron microscopy images of the positive coil end, positive coil segment, and strands segments show that pitting or electro-etching conditions have occurred at the break locations.However, due to metal dissolution and/or surface contamination the fracture mechanism cannot be ascertained.The inner silicone tubing of the lead coils has abraded openings at the ends.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.Since a portion of the lead (including the unmarked connector and the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
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