BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1062984 · Received June 18, 2008

    Report

    Report Number
    1644487-2008-01396
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 20, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P9700003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED. 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 PT RECEIVED HIGH LEAD IMPEDANCE. X-RAYS WERE REVIEWED BY THE MFR. NO GROSS LEAD DISCONTINUITIES WERE VISUALIZED. PT HAS BEEN RECOMMENDED FOR REVISION SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR