BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1963420 · Received December 20, 2010

    Report

    Report Number
    1644487-2010-02846
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 24, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD WOULD NOT POWER ON. ALL CONNECTIONS WERE CHECKED, AND BOTH A HARD AND SOFT RESET WAS PERFORMED, AND THE HANDHELD WOULD STILL NOT TURN ON. THE NON-WORKING HANDHELD, POWER CORD, SERIAL ADAPTER CABLE, AND SOFTWARE FLASHCARD HAVE BEEN RETURNED TO MANUFACTURER WHERE ANALYSIS IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 715906

    Patients

    Seq Age Sex Outcome Treatment
    1