BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1990001 · Received February 3, 2011

    Report

    Report Number
    1644487-2011-00186
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 5, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE OPERATING ROOM CIRCULATING NURSE THAT THEY WERE EXPERIENCING UNSPECIFIED PROGRAMMING SYSTEM ISSUES. THE NURSE REQUESTED A MANUFACTURER REP TO TRAVEL TO THE SITE TO PERFORM TROUBLESHOOTING. THE REP HAS SCHEDULED A TIME TO TRAVEL TO THE SITE, AND WILL OBTAIN MORE SPECIFIC INFO REGARDING THE ISSUES WITH THE PROGRAMMING SYSTEM AT THAT TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1