Generator product analysis was completed.The product analysis lab confirmed that the generator was at normal ifi (intensified follow-up indicator)=no condition.The reported high impedance and pin not fully inserted were not duplicated in the product analysis lab.A bench in-line lead fully inserted into the pulse generator header, past the negative connector block (lab conditions).There were no performance of any other type of adverse events found with the pulse generator.Lead product analysis was completed.The lead was returned in three portions and one loose tie downs.Electrodes were not returned therefore evaluation and resulting commentary cannot be made on that portion of the lead.During the visual analysis of the returned 342mm and 55mm portions, the connector ring quadfilar coil appeared to be broken.Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting.The area on the remaining broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting.Pitting was observed on the coil surface.The abraded open / cut area found on the outer and inner silicone tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubing.A set of 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, no anomalies were identified in the returned lead portions.
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