BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2182429 · Received July 11, 2011

    Report

    Report Number
    1644487-2011-01544
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 15, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    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

    REPORTER INDICATED A VNS DELL X50 HANDHELD COMPUTER WAS NOT PERFORMING AS INTENDED DESPITE TROUBLESHOOTING THE EQUIPMENT WITH A KNOWN GOOD VNS WAND AND COMPUTER. THE SUSPECT COMPUTER, PROGRAMMING WAND, AND FLASHCARD WERE RETURNED FOR PRODUCT ANALYSIS. ANALYSIS OF THE WAND DID NOT REVEAL ANY ANOMALIES AND THE WAND PERFORMED PER SPECIFICATIONS. ANALYSIS OF THE COMPUTER AND FLASHCARD IS STILL PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 863936

    Patients

    Seq Age Sex Outcome Treatment
    1