BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2830901 · Received November 13, 2012

    Report

    Report Number
    1644487-2012-02993
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 19, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED COMPUTER, FLASHCARD, AND DEMONSTRATOR VNS GENERATOR. NO ANOMALIES ASSOCIATED WITH THE HANDHELD WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. AN ANALYSIS OF THE HANDHELD AND FLASHCARD SOFTWARE IDENTIFIED THAT THE (B)(6) DATABASE WAS CORRUPT. A ROOT CAUSE FOR FILE CORRUPTION COULD NOT BE IDENTIFIED BASED ON THE AVAILABLE INFORMATION. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE (B)(6) DATABASE WAS NOT CORRUPT, GIVING THE INDICATION THAT THE FILE CORRUPTION DID NOT OCCUR PRIOR TO THE 8.1 SOFTWARE UPGRADE. BECAUSE THE ARCHIVE DATABASES WERE ALSO CORRUPT, IT COULD NOT BE DETERMINED IF THE FILE CORRUPTION OCCURRED DURING OR AFTER THE V8.1 UPGRADE. NO FURTHER ANOMALIES WERE IDENTIFIED. RESULTS OF DIAGNOSTIC TESTING FOR THE GENERATOR INDICATED THE DEVICE WAS OPERATING PROPERLY AND COMMUNICATED PROPERLY. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS DELL X5 COMPUTER WAS DISPLAYING SQL MESSAGES FOLLOWING AS SOFTWARE UPGRADE TO VNS VERSION 8.1 SOFTWARE. THE SQL ERROR WAS ALSO DUPLICATED WHEN A DEMONSTRATOR VNS GENERATOR WAS TESTED. THE COMPUTER, POWER CORD, SERIAL CABLE, FLASHCARD, AND DEMONSTRATOR VNS GENERATOR 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 1075834

    Patients

    Seq Age Sex Outcome Treatment
    1