BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1930337 · Received November 24, 2010

    Report

    Report Number
    1644487-2010-02683
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 25, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD COMPUTER IS OLD AND THE DATA ON THE SCREEN CAN HARDLY BE READ. PRODUCT HAS BEEN REQUESTED, BUT HAS NOT BEEN RETURNED TO THE MFR 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