BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2834091 · Received November 15, 2012

    Report

    Report Number
    1644487-2012-03026
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ANALYSIS OF THE VNS 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. 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.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS (B)(4) COMPUTER WITH (B)(4) SOFTWARE WAS FREEZING ON THE "INTERROGATION SUCCESSFUL" SCREEN. A BACKUP VNS COMPUTER WAS SUCCESSFULLY USED ALTERNATIVELY, SO NO PATIENTS WERE AFFECTED. THE COMPUTER AND FLASHCARD HAVE BEEN RETURNED AND ARE PENDING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1073167

    Patients

    Seq Age Sex Outcome Treatment
    1