BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2894103 · Received January 3, 2013

    Report

    Report Number
    1644487-2013-00024
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 28, 2012
    Report Date
    December 6, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN IT WAS REPORTED THAT THE HANDHELD AND FLASHCARD WERE RECEIVED BY THE MANUFACTURER FOR PRODUCT ANALYSIS ON (B)(6)2013. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2013 WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE HANDHELD AND FLASHCARD. AN ANALYSIS WAS PERFORMED ON THE HANDHELD AND NO ANOMALIES ASSOCIATED WITH THE HANDHELD 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 RETURNED FLASHCARD AND THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO SPECIFICATIONS. DURING THE ANALYSIS, NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(4) 2012 IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD WAS FREEZING ON VARIOUS SCREENS THE PREVIOUS WEDNESDAY. MULTIPLE HARD RESETS WERE PERFORMED BUT THE SCREEN WAS STILL FREEZING. ATTEMPTS FOR THE RETURN OF THE HANDHELD AND FLASHCARD WERE MADE BUT THE PRODUCTS HAVE NOT BEEN RETURNED FOR PRODUCT ANALYSIS TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3648 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1073167

    Patients

    Seq Age Sex Outcome Treatment
    1