BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING WAND

    MDR report key: 1203138 · Received October 17, 2008

    Report

    Report Number
    1644487-2008-02481
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 18, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT HE WAS HAVING PROBLEMS WITH HIS PROGRAMMING WAND. TROUBLESHOOTING STEPS WERE PERFORMED AND THE SITE INDICATED THAT THE WAND'S GREEN POWER LIGHT WOULD NOT ILLUMINATE WHILE THE RED RESET BUTTONS WERE PRESSED SIMULTANEOUSLY. THE PRODUCT WAS RETURNED AND IS CURRENTLY AWAITING 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