BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1062992 · Received June 18, 2008

    Report

    Report Number
    1644487-2008-01411
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT THEIR HANDHELD COMPUTER WAS "FREEZING AFTER INTERROGATION SUCCESSFUL SCREEN." A SOFT RESET, HARD RESET AND FLASHCARD REINSERTION WAS PERFORMED, BUT DID NOT RESOLVE THE PROBLEM. MFR IS PENDING RECEIPT OF THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 521379

    Patients

    Seq Age Sex Outcome Treatment
    1