BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1123853 · Received August 15, 2008

    Report

    Report Number
    1644487-2008-01895
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 17, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P870003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    IT WAS REPORTED THAT A SITE IS HAVING PROBLEMS WITH THEIR HANDHELD. WHEN THE NURSE TRIED TO TURN IT ON NOTHING WOULD HAPPEN. SHE ALWAYS KEEPS IT PLUGGED INTO THE WALL AND CHARGED. SHE TRIED TO TURN IT ON AND NOTHING WOULD MAKE IT TURN ON. CHECKED CONNECTIONS TO VERIFY THEY ARE ALL CONNECTED. A DIFFERENT OUTLET WAS USED AND IT STILL WOULD NOT TURN ON. A REPLACEMENT HANDHELD WAS SENT TO THE SITE. PRODUCT ANALYSIS IS PENDING ON THE HANDHELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 521417

    Patients

    Seq Age Sex Outcome Treatment
    1