BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1823573 · Received August 27, 2010

    Report

    Report Number
    1644487-2010-01960
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 2, 2010
    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 REPORTED THAT A NEUROLOGIST'S HANDHELD COMPUTER SCREEN WAS SHOWING HALF SCREEN WITH COLORED LINES VERTICAL AND THEN THE OTHER HALF OF THE SCREEN BLACK. THE NEUROLOGIST REPORTED THAT THE HANDHELD WAS WORKING OK LAST WEEK WITH NO PROBLEMS. A COMPANY REPRESENTATIVE ASSISTED THE NEUROLOGIST THROUGH TROUBLESHOOTING BY PERFORMING A HARD RESET BUT THE SCREEN CAME UP THE SAME AS IT WAS HALF SCREEN BLACK AND HALF VERTICAL LINES. A NEW HANDHELD COMPUTER WAS SENT TO THE NEUROLOGIST AND THE REPORTED HANDHELD WAS RETURNED TO THE MFR AND IS CURRENTLY UNDERGOING PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 530643

    Patients

    Seq Age Sex Outcome Treatment
    1