BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING WAND

    MDR report key: 1230884 · Received November 6, 2008

    Report

    Report Number
    1644487-2008-02620
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 14, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SITE'S PROGRAMMING WAND WOULD NOT TURN ON EVEN AFTER REPLACING THE BATTERY. THE PRODUCT WAS RETURNED AND IS CURRENTLY AWAITING ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1