BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1230459 · Received November 7, 2008

    Report

    Report Number
    1644487-2008-02676
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 10, 2008
    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

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT HE WAS EXPERIENCING COMMUNICATION ISSUES WITH HIS PROGRAMMING SYSTEM, ONCE THE REPORTER'S DELL X5 HAND HELD DEVICE WAS REPLACED WITH A NEW HAND HELD DEVICE, THE EVENT REPORTEDLY RESOLVED. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN ARE IN PROGRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR