BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1030365 · Received April 16, 2008

    Report

    Report Number
    1644487-2008-00933
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    K970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT THEIR HP JONADA HANDHELD COMPUTER CONNECTIONS WERE LOOSE. REPORTED "THE CHARGER WOULD NO LONGER FIT INTO THE HANDHELD COMPUTER. THE DEVICE WOULD BE PLUGGED INTO THE WALL TO CHARGE, BUT THE DEVICE WOULD DIE AS SOON AS IT WAS USED." THE HANDHELD COMPUTER IS AT MANUFACTURER PENDING COMPLETION OF PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 521383

    Patients

    Seq Age Sex Outcome Treatment
    1