Lead product analysis was performed.Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Setscrew marks were seen on the marked connector pin providing evidence that proper contact between the setscrew and the marked connector pin existed at least once.Other than typical wear and explant related observations (and the prior noted anomalies), no anomalies were identified in the returned lead portions.Generator analysis was completed.The product analysis lab confirmed that the generator was at normal ifi-no condition.High impedance was not observed on the generator.There were no performance of any other type of adverse events found with the pulse generator.The generator worksheet was received and there were no issues observed.
|