BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2922469 · Received January 18, 2013

    Report

    Report Number
    1644487-2013-00190
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    September 1, 2012
    Report Date
    December 21, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

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

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PROGRAMMING SYSTEM WAS HAVING INTERMITTENT COMMUNICATION ISSUES SINCE (B)(6) 2012, AND WAS NOW NOT COMMUNICATING AT ALL. THE REPORTER WAS USING THE PROGRAMMING SYSTEM WHILE PLUGGED INTO THE WALL OUTLET, SO THIS MAY BE THE CAUSE. THE BATTERY IN THE PROGRAMMING WAND WAS TESTED AND WAS SUFFICIENT. THE COMPUTER, FLASHCARD, AND WAND WERE RETURNED FOR ANALYSIS ON (B)(4) 2013. NO ANOMALIES WERE IDENTIFIED DURING THE WAND ANALYSIS, AND THE WAND PERFORMED AS INTENDED. ANALYSIS OF THE COMPUTER AND FLASHCARD IS STILL PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28072 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 842377

    Patients

    Seq Age Sex Outcome Treatment
    1