BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1041179 · Received May 9, 2008

    Report

    Report Number
    1644487-2008-01104
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 11, 2008
    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

    REPORTER INDICATED THAT INTERROGATION OF A PT'S VNS DEVICE SHOWED THE DEVICE TO NOT BE AT THE INTENDED SETTINGS AS PROGRAMMED AT A PRIOR OFFICE VISIT. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 537101

    Patients

    Seq Age Sex Outcome Treatment
    1