BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1191489 · Received September 26, 2008

    Report

    Report Number
    1644487-2008-02360
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PROGRAMMING HANDHELD FREEZING AT THE INTERROGATION SCREEN. THE PROGRAMMING SYSTEM HAS BEEN RETURNED TO THE MANUFACTURER AND IS PENDING PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 166242

    Patients

    Seq Age Sex Outcome Treatment
    1