It was reported that during replacement surgery on (b)(6) 2013, the patient¿s device was tested and diagnostic results showed high impedance.The lead pin was reinserted into the generator header multiple times, but the device continued to show high impedance.The patient¿s generator was explanted and generator diagnostic showed end of service.No issues were noted with the lead electrodes attachment to the vagus nerve.The surgeon elected to replace the patient¿s generator and lead.Following replacement, diagnostic results continued to show high impedance.The vagus nerve was irrigated and the impedance value was reported to be decreasing; however, the patient device continued to show high impedance.The lead pin was reinserted into the generator header and diagnostic results finally showed lead impedance within normal limits.The surgeon attributed the high impedance to fibrosis.X-rays prior to surgery were reported by the surgeon to be unremarkable.The explanted generator and lead have not been returned to date.Attempts for additional relevant information have been unsuccessful to date.
|
Age at time of event or date of birth; corrected data: previously submitted mdr indicated this information was unknown.It is now known.This report is being submitted to correct this data.Sex; corrected data: previously submitted mdr indicated this information was unknown.It is now known.This report is being submitted to correct this data.Brand name, corrected data: previously submitted mdr indicated this information was unknown.It is now known.This report is being submitted to correct this data.Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated this information was unknown.It is now known.This report is being submitted to correct this data.Implant date, corrected data: previously submitted mdr indicated this information was unknown.It is now known.This report is being submitted to correct this data.Explant date, corrected data: previously submitted mdr inadvertently provided an incorrect explant date.This report is being submitted to correct this data.Manufacture date, corrected data: previously submitted mdr indicated this information was unknown.It is now known.This report is being submitted to correct this data.
|