During a battery replacement upon dissection of the generator pocket, it was found that the generator was sitting on a calcified plate, exposing lead degradation.Once a new generator was implanted, low impedance was seen.Two days later the patient then underwent a full revision.The explanted products have not been received by product analysis to date.No other relevant information has been received to date.
|
Product analysis was completed on the returned generator and lead.The electrical tests performed in the pa lab found that the generator was at an ifi = no condition.The battery voltage was measured at 3.055 volts, and the memory locations on the generator indicated that 3.471% of the battery had been consumed.There were no performance, or any other type of adverse condition found with the pulse generator.The lead analysis was completed but note that since a significant portion of the lead assembly (body) including the electrode array section was not returned for analysis, a complete evaluation could not be performed on the entire lead product.The reported low impedance was partially confirmed in the pa lab.A low impedance condition was identified due to exposed intertwined conductive coils, however that condition likely occurred during explant procedure.With the exception of the noted conditions above, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were identified in the returned lead portions.
|