BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3192287 · Received June 27, 2013

    Report

    Report Number
    1644487-2013-01938
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    March 1, 2013
    Report Date
    June 3, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HANDHELD AND FLASHCARD WERE RECEIVED FOR ANALYSIS. ANALYSIS OF THE HANDHELD WAS COMPLETED ON (B)(4) 2014. 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. ANALYSIS OF THE FLASHCARD WAS COMPLETED ON (B)(4) 2014. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE PHYSICIAN¿S HANDHELD WAS NOT HOLDING A CHARGE DESPITE BEING PLUGGED IN. IT WAS STATED THAT THE HANDHELD WOULD CHARGE OVERNIGHT BUT THEN ONCE UNPLUGGED IT WOULD QUICKLY DEPLETE. IT WAS STATED THAT IT STARTED OVER THE LAST FEW MONTHS, BUT THE EXACT DATE WAS UNKNOWN. IT WAS STATED THAT THE HANDHELD WOULD BE RETURNED FOR PRODUCT ANALYSIS BUT IT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293555 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 839583

    Patients

    Seq Age Sex Outcome Treatment
    1