BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1022732 · Received March 27, 2008

    Report

    Report Number
    1644487-2008-00783
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. RESULTS - X-RAYS REVIEWED BY THE MFR, ALTHOUGH NO GROSS LEAD DISCONTINUITIES VISUALIZED, IT COULD NOT BE CONFIRMED THAT THE LEAD PIN WAS FULLY INSERTED, THE STRAIN RELIEF APPEARED IN ADEQUATE, NO TIE DOWNS WERE VISIBLE, AND THE ORIENTATION OF THE ELECTRODES APPEARED ATYPICAL. CONCLUSIONS - DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT DIAGNOSTIC TESTS INDICATED HIGH LEAD IMPEDANCE. IT WAS REPORTED THAT THE PT HAD EXPERIENCED AN INCREASE IN SEIZURES, WHICH WERE AT PRE-VNS BASELINE LEVELS. IT WAS ALSO REPORTED THAT THE PT FALLS "QUITE A BIT". X-RAYS WERE REVIEWED BY THE MFR, AND IT COULD NOT BE CONFIRMED THAT THE LEAD PIN WAS FULLY INSERTED. ADDITIONALLY, THE STRAIN RELIEF WAS NOT PLACED ACCORDING TO LABELING WITH A SHARP ANGLE BELOW THE POSITIVE ELECTRODE, NO TIE-DOWNS WERE VISIBLE, AND THE ELECTRODES DID NOT APPEAR TO BE IN THE TYPICALLY OBSERVED ORIENTATION. REVISION SURGERY IS LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 200437

    Patients

    Seq Age Sex Outcome Treatment
    1 Other