BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2801638 · Received October 23, 2012

    Report

    Report Number
    1644487-2012-02699
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 27, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A NEUROLOGIST REPORTED TO THEIR CONSULTANT THAT THEIR HANDHELD COMPUTER HAD BLACK LINES ACROSS THE SCREEN, WHICH APPEARED TO BE DUE TO THE PIXELS NO LONGER WORKING. A HARD RESET WOULDN'T RESOLVE THE ISSUE. THE HANDHELD HAS BEEN RETURNED FOR ANALYSIS AND IS PENDING COMPLETION.

    Description of Event or Problem · 1

    AN ANALYSIS WAS PERFORMED ON THE RETURNED HANDHELD AND THE REPORTED ALLEGATION WAS NOT VERIFIED. NO ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 1067570

    Patients

    Seq Age Sex Outcome Treatment
    1 MA