BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1970040 · Received January 14, 2011

    Report

    Report Number
    1644487-2011-00065
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 19, 2010
    Report Date
    December 17, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED, A PATIENT'S SEIZURES WERE INCREASED AND UPON INTERROGATION OF THE VNS, IT WAS NOTED THE OUTPUT CURRENT AND MAGNET OUTPUT CURRENTS WERE SET TO 0MA. THE VNS SETTINGS WERE ADJUSTED BACK TO THE INTENDED SETTINGS. IT WAS SUSPECTED AN INTERRUPTED VNS DIAGNOSTICS TEST OCCURRED AT A PREVIOUS OFFICE VISIT WHICH CAUSED THE VNS SETTINGS TO CHANGE. ATTEMPTS FOR FURTHER INFORMATION ARE IN PROGRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Required Intervention