The patient's explanted devices were returned for analysis.Product analysis was completed for the generator and lead.The generator performed according to functional specifications and analysis of the device found no abnormalities or malfunctions.The explanted lead was returned in five portions.Visual examination of the portions found that the setscrew marks were observed on the connector pin, indicating a proper mechanical contact between the conductive surfaces of both the generator and connector pin, ensuring a good electrical connection with the lead.The quadfilar coil 1 appeared to be broken near the anchor tether.Scanning electron microscopy was performed and identified the area on three of the broken coil strands as being mechanically damaged, with pitting and residual material.Pitting was observed on the coil surface, and was likely related to stimulation present for a certain period of time.No other anomalies were noted.Based on the findings from product analysis, there was evidence to suggest a discontinuity in the returned portions of the device.Note that since the positive and negative electrodes were not returned, no analysis could be performed on those portions of the lead.No additional relevant information has been received to date.
|