BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2063272 · Received March 22, 2011

    Report

    Report Number
    1644487-2011-00600
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PHYSICIAN'S PROGRAMMING SYSTEM WAS NOT INTERROGATING CONSISTENTLY. A MESSAGE WOULD COME UP STATING COMMUNICATION WAS BEING ESTABLISHED, THEN A MESSAGE "SENDING FLASH INTERROGATION REQUEST" WOULD COME UP AND CHANGE TO "FAILED TO RESPOND TO INTERROGATION" ALL IN QUICK SUCCESSION. THIS WAS ONLY OCCURRING WITH THE 103 TEST GENERATOR AND NOT WITH THE 102 OR 101 TEST GENERATORS. THE COMPANY REP ENSURED THAT THE WAND BATTERY WAS SUFFICIENT, THE SYSTEM NOT PLUGGED INTO A WALL OUTLET, AND ALL CABLE CONNECTIONS WERE FINE. A HARD RESET WAS PERFORMED ON THE DELL X5 AND THE ATTEMPT TO INTERROGATE THE M103 DEMO GENERATOR FAILED AGAIN, GIVING THE SAME SEQUENCE OF EVENTS AS PREVIOUSLY MENTIONED. THE HANDHELD AND FLASHCARD WERE RETURNED TO THE MFR FOR EVAL. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECS. DURING THE ANALYSIS OF THE HANDHELD, IT WAS IDENTIFIED THAT THE SERIAL CABLE WAS UNABLE TO ESTABLISH COMMUNICATION BETWEEN THE HANDHELD AND A KNOWN GOOD WAND. THE CAUSE FOR THE COMMUNICATION DIFFICULTIES IS ASSOCIATED WITH BROKEN WIRE CONNECTIONS IN THE DELL AXIM CONNECTOR PLUG ASSEMBLY. ONCE THE WIRES WERE SOLDERED ONTO THE DELL AXIM CONNECTOR PLUG PCB, THE SERIAL CABLE WAS ABLE TO ESTABLISH COMMUNICATION BETWEEN THE HHD AND WAND. THE CAUSE FOR THE WIRE BREAKS ARE UNK, BUT IS LIKELY ASSOCIATED WITH MISHANDLING OF THE SERIAL CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 839583

    Patients

    Seq Age Sex Outcome Treatment
    1