BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1053152 · Received May 27, 2008

    Report

    Report Number
    1644487-2008-01225
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 28, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS COMPUTER WAS FREEZING. THE COMPUTER AND FLASHCARD HAVE BEEN RETURNED, AND ARE CURRENTLY IN PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 521377

    Patients

    Seq Age Sex Outcome Treatment
    1