BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT ESSENTIALS KIT

    MDR report key: 1213116 · Received October 23, 2008

    Report

    Report Number
    1644487-2008-02560
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 23, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    RPTR INDICATED THAT THE MAGNET HAS NOT SEEMED TO WORK FOR THE PAST FEW WEEKS. WHENEVER THEY SWIPE IT, THE PT DOES NOT COUGH LIKE BEFORE. THE DOCTOR INCREASED MAGNET OUTPUT SETTINGS TO 1.75 MA AND STILL DOES NOT MAKE THE PT COUGH EVEN THOUGH THE PT COUGHS WITH THE 1.0 MA NORMAL OUTPUT. IT WAS ALSO NOTED THAT THE MAGNET DOES NOT HAVE AS STRONG OF AN ATTRACTION TO METALS AS BEFORE. TROUBLESHOOTING WAS PERFORMED BY A MANUFACTURER REPRESENTATIVE, BUT WAS UNSUCCESSFUL IN RESOLVING THE ISSUE. NONE OF THE MAGNET SWIPES THAT WERE PERFORMED AT THE DOCTOR'S OFFICE SHOW UP ON THE STORED MAGNET HISTORY. IT WAS ALSO NOTED THAT THE MAGNET IS NOT BROKEN. ALL ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. PRODUCT HAS BEEN REQUESTED, BUT HAS NOT BEEN RETURNED TO MANUFACTURER TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT ESSENTIALS KIT LYJ CYBERONICS, INC. 596728

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR