BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1881237 · Received October 6, 2010

    Report

    Report Number
    1644487-2010-02245
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    REPORTER INDICATED A VNS DELL X5 HANDHELD COMPUTER WAS NOT WORKING PROPERLY. TROUBLESHOOTING WITH KNOWN WORKING EQUIPMENT ISOLATED THE HANDHELD'S SERIAL CABLE AS THE PROBABLE FAULTY COMPONENT. ATTEMPTS FOR PRODUCT RETURN ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 521386

    Patients

    Seq Age Sex Outcome Treatment
    1