BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2050182 · Received April 1, 2011

    Report

    Report Number
    1644487-2011-00691
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE "CFCARD" FOLDER WAS NOT ABLE TO BE SEEN ON THE FLASHCARD THAT WAS BEING USED TO UPGRADE THE HANDHELD. THE COMPANY REP PERFORMED A HARD RESET BUT THE ISSUE REMAINED. ANOTHER FLASHCARD WAS USED TO TRY TO UPGRADE THE HANDHELD AND WAS SUCCESSFUL. THE FLASHCARD WAS RETURNED TO THE MFR FOR EVAL. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 834042

    Patients

    Seq Age Sex Outcome Treatment
    1