Analysis of the returned lead was completed.Scanning electron microscopy images of the lead coils at the exposed portions and at the cut ends show that the coils were exposed some type of electro-cautery tool.Based on the appearance of the returned lead this was most likely caused at explant.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.Note that since the electrode array portion was not returned for analysis, an evaluation cannot be made on that portion of the lead.
|