BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING WAND

    MDR report key: 1810822 · Received February 29, 2008

    Report

    Report Number
    1644487-2008-00583
    Event Type
    Malfunction
    Date Received
    February 29, 2008
    Date of Event
    January 31, 2008
    Report Date
    January 31, 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 THAT THE PROGRAMMING WAND WAS NOT FUNCTIONING PROPERLY AND THAT COMMUNICATION COULD NOT BE ESTABLISHED WHEN USING THE WAND. PRODUCT HAS BEEN RECEIVED BACK BY THE MFR, AND THERE WERE NO OBSERVED ANOMALIES AND THE WAND PERFORMED ACCORDING TO SPECS IN THE PA LAB.

    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