BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2181242 · Received July 8, 2011

    Report

    Report Number
    1644487-2011-01527
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S VNS WAS NOT SHOWING THE VNS MAGNET ACTIVATIONS CORRECTLY AFTER THE MAGNET STIMULATION HAD BEEN INITIATED. THE MAGNET WAS REPORTEDLY SWIPED HOWEVER, THE VNS DID NOT SHOW THE ACTIVATION AS OCCURRING. ATTEMPTS FOR FURTHER INFO AND PROGRAMMING HISTORY ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 874809

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR