BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2170954 · Received June 30, 2011

    Report

    Report Number
    1644487-2011-01467
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    ON (B)(6) 2011, THE MFR'S CONSULTANT REPORTED THAT WHILE SHE WAS COMPLETING THE 8.0 SOFTWARE UPGRADE ON THE VNS TREATING PHYSICIAN'S HANDHELD, THE HANDHELD WAS GIVING AN ERROR NOTIFICATION MESSAGE. THE CONSULTANT ATTEMPTED TO DO A HARD RESET AND AFTER DONG SO THE SCREEN WAS FROZEN AT THE "CLEAR ALL DATA" SCREEN. SHE SAID THAT NO MATTER WHAT BUTTON WAS PRESSED, THE SCREEN STAYED FROZEN. THE CONSULTANT SENT THE HANDHELD, FLASHCARD, AND WAND BACK FOR PRODUCT ANALYSIS. THE PROGRAMMING WAND PERFORMED ACCORDING TO FUNCTIONAL SPECS; NO MALFUNCTION WAS IDENTIFIED WITH THE PROGRAMMING WAND. NO VISUAL OR MECHANICAL ANOMALY WAS IDENTIFIED AND CONTINUITY TESTING OF THE SERIAL DATA CABLE AND THE BATTERY CABLE PASSED. DURING THE FLASHCARD ANALYSIS NO ANOMALIES ASSOCIATED WITH THE FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED; THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECS. PRODUCT ANALYSIS ON THE HANDHELD CONFIRMED THAT THE HANDHELD WAS UNABLE TO PROGRESS PAST THE "CLEAR ALL DATA" SCREEN AND COMPLETE A HARD RESET. THE CAUSE FOR THE REPORTED COMPLAINT IS ASSOCIATED WITH A LOOSE/DISCONNECTED CABLE THAT MADE THE CONTACTS BUTTON UNRESPONSIVE. ONCE THE CABLE WAS RESEATED TO THE MAIN BOARD, NO FURTHER ANOMALIES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 841226

    Patients

    Seq Age Sex Outcome Treatment
    1