BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 300

    MDR report key: 1190869 · Received September 24, 2008

    Report

    Report Number
    1644487-2008-02145
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, 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 SHE PERFORMED MAGNET, NORMAL MODE, AND SYSTEM DIAGNOSTICS ON THE PT AND GOT 7/LIMIT/HIGH ON ALL THREE. PT DENIED HAVING ANY TRAUMA OR ACCIDENTS LATELY AND DOCTOR DOES NOT BELIEVE THERE WAS ANY MANIPULATION OF THE DEVICE BY THE PT. X-RAYS WERE PERFORMED AND SENT TO MANUFACTURER FOR FURTHER EVALUATION, BUT SITE FOUND NOTHING ABNORMAL ON X-RAYS. PT WILL BE SEEN FOR CONSULT FOR REVISION SURGERY SOON. ALL ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 25146C

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR