BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 5656619 · Received May 16, 2016

    Report

    Report Number
    1644487-2016-01024
    Event Type
    Malfunction
    Date Received
    May 16, 2016
    Date of Event
    May 9, 2016
    Report Date
    May 9, 2016
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LJY
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HANDHELD DEVICE (HHD) WAS RECEIVED WITH AN AC ADAPTER, SERIAL CABLE, FLASHCARD SOFTWARE, AND PROGRAMMING WAND. UPON RECEIPT, THE MAIN BATTERY WAS DEPLETED. THE HANDHELD DEVICE WAS POWERED USING THE RETURNED AC POWER SUPPLY WITH NO ANOMALIES. DURING STARTUP, THE CHARGE LIGHT ON THE POWER BUTTON WAS FLASHING GREEN AND AMBER INDICATING THAT THE MAIN BATTERY WAS NOT BEING CHARGED RELIABLY BY THE HANDHELD. THE HHD WAS OPENED AND A VISUAL INSPECTION IDENTIFIED THAT THE SOLDER CONNECTIONS BETWEEN THE MAIN BATTERY TERMINAL AND MAIN BOARD WERE BROKEN. ONCE THE CONNECTIONS WERE RE-SOLDERED, BATTERY CHARGING RETURNED TO NORMAL AND THE HANDHELD DEVICE FUNCTIONED NORMALLY. THE HANDHELD WAS POWERED-ON CONTINUOUSLY USING ONLY THE MAIN BATTERY FOR MORE THAN AN HOUR. AT THE CONCLUSION OF TESTING, THE MAIN BATTERY HAD A REMAINING CHARGE OF 42%. NO OTHER ANOMALIES WERE IDENTIFIED. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO ANOMALIES WERE FOUND WITH THE RETURNED PROGRAMMING WAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313061 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LJY CYBERONICS - HOUSTON MODEL 250 841226

    Patients

    Seq Age Sex Outcome Treatment
    1