BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1706615 · Received May 17, 2010

    Report

    Report Number
    1644487-2010-01184
    Event Type
    Malfunction
    Date Received
    May 17, 2010
    Date of Event
    April 15, 2010
    Report Date
    April 19, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A VNS PROGRAMMING PHYSICIAN REPORTED THAT THEIR (B)(6) HANDHELD COMPUTER CONTAINING 7.1 PROGRAMMING SOFTWARE HAD A BLANK WHITE SCREEN AND THE TOP PORTION OF THE SCREEN LOOKED LIKE GREY WALLPAPER WITH HORIZONTAL BARS. 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 678297

    Patients

    Seq Age Sex Outcome Treatment
    1