BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1913350 · Received November 11, 2010

    Report

    Report Number
    1644487-2010-02537
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 21, 2010
    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 A PHYSICIAN'S (B)(4) HANDHELD DEVICE WOULD NOT HOLD A CHARGE DESPITE BEING PLUGGED IN OVERNIGHT. THE HANDHELD WAS NOT MISHANDLED NOR WAS IT STORED NEAR A HEAT SOURCE. THE PHYSICIAN WAS SENT A REPLACEMENT HANDHELD AND THE (B)(4) IN QUESTION WAS RETURNED TO THE MFR FOR ANALYSIS. DURING ANALYSIS, IT WAS FOUND THAT THE SOLDER CONNECTIONS ON THE MAIN BOARD OF THE HANDHELD WERE BROKEN. AFTER THE BROKEN CONNECTIONS WERE RESOLDERED TO THE MAIN BOARD, NO FURTHER ANOMALIES ASSOCIATED WITH THE HANDHELD 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 715913

    Patients

    Seq Age Sex Outcome Treatment
    1