Analysis of the generator and lead were completed.Electrical test results showed that the pulse generator performed according to functional specifications.Other than the noted condition there were no adverse functional, mechanical, or visual issues identified with the returned generator.Analysis of the lead identified a break in the negative coil.An abraded opening was noted in the outer tubing.Also, openings in the outer and the inner silicone tubing were identified at the lead body with an appearance which suggests the tubing was in contact with some type of electro-cautery tool.Scanning electron microscopy images of the coils at the inner tubing openings suggest the coils were in contact with some type of electro-cautery tool as indicated by the appearance of the negative coil.Scanning electron microscopy images of the negative coil at the fifth portion of the returned lead show that pitting or electro-etching conditions have occurred at the break location.However, due to metal dissolution, surface contamination and/or mechanical distortion (smoothed surfaces) the fracture mechanism cannot be ascertained.Note that since a portion of the lead 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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