BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1940145 · Received December 23, 2010

    Report

    Report Number
    1644487-2010-02889
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Report Date
    November 24, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDHELD SCREEN WOULD FREEZE OFTEN. TROUBLESHOOTING WAS PERFORMED, BUT THE PROBLEM PERSISTED. ATTEMPTS FOR FURTHER INFO AND 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

    Patients

    Seq Age Sex Outcome Treatment
    1