BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1913349 · Received November 11, 2010

    Report

    Report Number
    1644487-2010-02539
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 15, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 A PHYSICIAN WAS HAVING PROBLEMS WITH THE PROGRAMMING SYSTEM. A COMPANY REP WENT TO THE PHYSICIAN'S OFFICE TO TROUBLESHOOT AND FOUND THAT THE PHYSICIAN'S PROGRAMMING SYSTEM COULD NOT INTERROGATE A DEMO GENERATOR. THE HANDHELD WAS NOT PLUGGED INTO THE WALL, THE CONNECTIONS WERE SECURE, AND THE WAND BATTERY WAS WORKING PROPERLY. THE WAND BATTERY WAS CHANGED AND INTERROGATION WAS STILL NOT POSSIBLE. THE COMPANY REP USED HIS WAND WITH THE PHYSICIAN'S CABLES AND HANDHELD AND INTERROGATION WAS NOT POSSIBLE INDICATING THAT THE ISSUE WAS MOST LIKELY WITH EITHER THE HANDHELD OR CABLES. THE PHYSICIAN WAS SENT A NEW PROGRAMMING SYSTEM AND THE PROGRAMMING SYSTEM IN QUESTION WAS RETURNED TO THE MFR. PRODUCT ANALYSIS ON ALL PRODUCTS HAS BEEN COMPLETED. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PROGRAMMING WAND. THE WAND PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. 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 A BROKEN WIRE CONNECTION IN THE DELL AXIM CONNECTOR PLUG ASSEMBLY. ONCE THE WIRE WAS 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 BREAK IS UNK, BUT IS LIKELY ASSOCIATED WITH MISHANDLING OF THE SERIAL CABLE. NO FURTHER ANOMALIES ON THE DEVICE PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 523502

    Patients

    Seq Age Sex Outcome Treatment
    1