BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3131696 · Received May 29, 2013

    Report

    Report Number
    1644487-2013-01618
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    January 1, 2012
    Report Date
    May 2, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ANALYSIS OF THE COMPUTER AND FLASHCARD WAS COMPLETED.NO ANOMALIES ASSOCIATED WITH THE HANDHELD COMPUTER WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS DELL X5 COMPUTER WAS FREEZING AT THE INITIAL SCREEN EVERY TIME AN INTERROGATION WAS ATTEMPTED. PERFORMING A HARD RESET DOES NOT RESOLVE THE SCREEN FREEZING. THE COMPUTER AND FLASHCARD HAVE BEEN RETURNED AND ARE PENDING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234280 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1067559

    Patients

    Seq Age Sex Outcome Treatment
    1