BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2100282 · Received May 16, 2011

    Report

    Report Number
    1644487-2011-01084
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 18, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, LEAD PIN NOT FULLY INSERTED PAST THE CONNECTOR BLOCK OF GENERATOR. BRAND NAME, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LISTED INCORRECT BRAND NAME. NAME, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LISTED INCORRECT NAME. MODEL #, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LISTED INCORRECT MODEL NUMBER. SERIAL #, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LISTED INCORRECT SERIAL NUMBER. EXPIRATION DATE, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LISTED INCORRECT EXPIRATION DATE. IMPLANT DATE, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LISTED INCORRECT IMPLANT DATE. DEVICE MANUFACTURE DATE, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LISTED INCORRECT MANUFACTURE DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A COMPANY REP THAT HIGH IMPEDANCE WAS REC'D DURING A F/U VISIT WITH HER TREATING PHYSICIAN. FURTHER INFO REC'D FROM THE COMPANY REP INDICATED THAT THE PT'S DEVICE WAS PROGRAMMED OFF DUE TO THE HIGH LEAD IMPEDANCE. NO PT TRAUMA OR MANIPULATION WAS REPORTED TO THE TREATING PHYSICIAN. X-RAYS WERE TAKEN FOR THE TIME BEING AND NO INTERVENTIONS HAVE BEEN PLANNED FOR THE MOMENT. X-RAYS WERE REC'D AND ANALYZED BY THE MFR. REVIEW OF X-RAYS REVEALED THAT THE GENERATOR PLACEMENT APPEARED TO BE NORMAL, AND THE FILTER FEED-THROUGH WIRES APPEARED TO BE INTACT. THE LEAD CONNECTOR PIN APPEARED TO NOT FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE ELECTRODES APPEARED TO BE PLACED IN NORMAL ARRANGEMENT. LONG PORTION OF THE LEAD WAS BEHIND THE GENERATOR. THE LEAD FOLLOWS VERY STRAIGHT LINE BETWEEN THE NECK AND THE CHEST. NO ACUTE ANGLES WERE OBSERVED IN OTHER PORTIONS OF THE LEAD BODY THAT COULD BE ASSESSED. AT THE MOMENT PLANS FOR REPLACEMENT SURGERY ARE UNK AS GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO ARE UNDERWAY.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED FROM THE PATIENT'S TREATING PHYSICIAN INDICATING THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY IN (B)(6) 2011. FOLLOW-UP WAS MADE FROM THE AREA REPRESENTATIVE WITH THE EXPLANTING SURGEON, WHO INDICATED THE GENERATOR WAS JUST REPLACED DUE TO DEAD BATTERY AND THE LEAD REMAIN IN PLACE. THE GENERATOR WAS DISCARDED AFTER SURGERY AND SURGEON WAS INFORMED ABOUT THE PROCESS TO RETURN EXPLANTS. NO FURTHER INTERVENTIONS HAVE BEEN PLANNED AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR