BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2851417 · Received November 29, 2012

    Report

    Report Number
    1644487-2012-03146
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012 IT WAS REPORTED THAT THE HANDHELD'S SCREEN WAS FREEZING FROM TIME TO TIME. IT WAS NOTED THAT DOING A HARD RESET WOULD NOT HELP THE ISSUE. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME. THE HANDHELD, FLASHCARD, AND SERIAL CABLE WERE RETURNED FOR PRODUCT ANALYSIS ON (B)(6) 2012. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012 WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE HANDHELD AND FLASHCARD. NO ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. AN ANALYSIS WAS PERFORMED ON THE FLASHCARD AND NO ANOMALIES THAT COULD HAVE CONTRIBUTED TO THE FROZEN SCREEN EVENT WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE FLASHCARD CONTAINED 4 DIFFERENT PATIENT DATABASE FILES. THE MOST LIKELY CAUSE FOR THE MULTIPLE DATABASES IS ASSOCIATED WITH THE FLASHCARD BEING INSERTED INTO MULTIPLE HANDHELDS. NO OTHER ANOMALIES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 678292

    Patients

    Seq Age Sex Outcome Treatment
    1