BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1062991 · Received June 18, 2008

    Report

    Report Number
    1644487-2008-01412
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 12, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P9700003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A (B) (4) HANDHELD VNS COMPUTER WAS FREEZING DURING INTERROGATION. THE FLASHCARD WAS REINSERTED AND THE FREEZING RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 521396

    Patients

    Seq Age Sex Outcome Treatment
    1