BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2063273 · Received March 22, 2011

    Report

    Report Number
    1644487-2011-00602
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    September 1, 2009
    Report Date
    February 21, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PHYSICIAN'S PROGRAMMING SYSTEM WAS HAVING COMMUNICATION ISSUES. THE COMPANY REP PERFORMED TROUBLESHOOTING BY REPLACING DIFFERENT COMPONENTS AND ISOLATED THE ISSUE TO THE SERIAL CABLE. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 521413

    Patients

    Seq Age Sex Outcome Treatment
    1