BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2102362 · Received May 20, 2011

    Report

    Report Number
    1644487-2011-01149
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    October 20, 2008
    Report Date
    May 13, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING MFR REVIEW OF A VNS PT'S PROGRAMMING HISTORY, IT WAS IDENTIFIED THAT ON (B)(6) 2008 THAT THE PARAMETERS WERE DEFAULT SYSTEMS DIAGNOSTICS SETTING (0MA/20HZ/500PULSEWIDTH/30 SEC ON/60 MIN OFF). THE SETTINGS WERE CORRECTED TO 2MA/20HZ/250PULSEWIDTH/30 SEC ON/1.1 MIN OFF. IT IS SUSPECTED AN INTERRUPTED SYSTEMS DIAGNOSTICS TEST OCCURRED WITH A DIFFERENT VNS PROGRAMMING SYSTEM AT THE PREVIOUS OFFICE VISIT ON (B)(6) 2008.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR