BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2043555 · Received March 28, 2011

    Report

    Report Number
    1644487-2011-00651
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A VNS PROGRAMMING OFFICE NURSE IN THE (B)(6) REPORTED TO OUR COUNTRY REP THAT THEIR VNS PROGRAMMING HANDHELD COMPUTER STOPPED WORKING. TROUBLESHOOTING WAS PERFORMED AT THE SITE BUT THE HANDHELD WAS REPORTED TO BE NOT WORKING. GOOD FAITH ATTEMPTS ARE UNDERWAY TO HAVE THE PRODUCT RETURNED FOR ANALYSIS.

    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