BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3030111 · Received April 2, 2013

    Report

    Report Number
    1644487-2013-00882
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE LANGUAGE COULD NOT BE SET TO (B)(6). WHEN ATTEMPTING TO DO SO, THE USER COULD NOT HIT THE 'OK' BUTTON. A HARD RESET SUCCEEDED IN GETTING THE DEVICE TO WORK. ADDITIONAL INFORMATION WAS RECEIVED THAT TAKING OUT THE FLASHCARD AND PLACING IT BACK IN RESOLVED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133987 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1063524

    Patients

    Seq Age Sex Outcome Treatment
    1