Product analysis was completed on the returned lead.During analysis, abraded openings were noted on the outer and inner silicone tubing.The scanning electron microscopy images of the positive coil at the first portion of the returned lead show that pitting or electro-etching conditions have occurred on the surface of the coil.Also, the positive coil shows what appears to be wear (flat surfaces) at this region.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.It is unknown when and how the abraded openings occurred.
|