BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2050087 · Received March 31, 2011

    Report

    Report Number
    1644487-2011-00681
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 2, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PHYSICIAN'S PROGRAMMING SYSTEM WAS NOT FUNCTIONING CORRECTLY. IT WAS FOUND THAT THE CONNECTOR IN THE HANDHELD WAS LOOSE AND PREVENTED PATIENTS FROM BEING INTERROGATED. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 840143

    Patients

    Seq Age Sex Outcome Treatment
    1