BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2991922 · Received March 6, 2013

    Report

    Report Number
    1644487-2013-00614
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    September 1, 2012
    Report Date
    February 11, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS DELL X5 COMPUTER WITH 8.1 VERSION SOFTWARE WAS FREEZING ON THE 'INTERROGATION SUCCESSFUL' SCREEN. RESEATING THE FLASHCARD DID NOT RESOLVE THE ISSUE. THE COMPUTER AND FLASHCARD HAVE BEEN RETURNED AND ARE PENDING ANALYSIS.

    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 COMPUTER PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO SPECIFICATIONS. DURING THE ANALYSIS, NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94676 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1073772

    Patients

    Seq Age Sex Outcome Treatment
    1