BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING WAND

    MDR report key: 1190683 · Received October 6, 2008

    Report

    Report Number
    1644487-2008-02421
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT THEIR PROGRAMMING WAND WAS GETTING THE ERROR MESSAGE "ERROR ESTABLISHING COMMUNICATION." THE BATTERY IN THE WAND WAS CHECKED AND IT WAS "FINE" AND THE PROGRAMMING SYSTEM WAS NOT PLUGGED INTO THE WALL. THE WAND IS AT MANUFACTURE PENDING COMPLETION OF PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING WAND LYJ CYBERONICS, INC. 201

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR