BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 927161 · Received October 15, 2007

    Report

    Report Number
    1644487-2007-01620
    Event Type
    Malfunction
    Date Received
    October 15, 2007
    Date of Event
    September 1, 2007
    Report Date
    September 27, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H.6. DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PROGRAMMING SYSTEM WOULD NOT COMMUNICATE WITH PATIENTS' GENERATORS. TROUBLESHOOTING WAS PERFORMED ON THE SYSTEM AND THE DELL HHD SERIAL CONNECTION WAS FOUND TO BE LOOSE AND WHEN MANIPULATED, COMMUNICATION WAS SUCCESSFUL. THE HHD, SERIAL ADAPTER CABLE, AND FLASHCARD WERE RETURNED AND ANALYSIS WAS PERFORMED. NO ANOMALIES WERE FOUND WITH THE SERIAL ADAPTER OR FLASHCARD AS THEY WERE PERFORMED ACCORDING TO SPECIFICATIONS. DURING ANALYSIS OF THE HHD, IT WAS IDENTIFIED THAT THE HHD HAD COMMUNICATION DIFFICULTIES. THE CAUSE FOR THE COMMUNICATION DIFFICULTIES WAS ASSOCIATED WITH A BENT PIN IN THE HHD SERIAL CONNECTOR. AFTER THE PIN WAS STRAIGHTENED, NO FURTHER ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE NONE LYJ CYBERONICS, INC. MODEL 250 521391

    Patients

    Seq Age Sex Outcome Treatment
    1 YR