BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1834525 · Received September 10, 2010

    Report

    Report Number
    1644487-2010-02068
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 11, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER BY THE PHYSICIAN THAT THE (B)(4) X50 HAND HELD WAS NOT HOLDING A CHARGE. THE PHYSICIAN NOTED THAT THE HAND HELD IS ALWAYS PLUGGED IN TO CHARGE WHEN NOT IN USE. THE MANUFACTURER REPRESENTATIVE WAS AT THE PHYSICIAN'S OFFICE, AND NOTED THAT WHEN HE HAD ARRIVED, THE HAND HELD DID APPEAR TO BE FULLY CHARGED WHEN PLUGGED IN, BUT ONCE IT IS UNPLUGGED FROM THE OUTLET, THE BATTERY CAPACITY DROPS QUICKLY. THE HAND HELD WAS RETURNED TO MANUFACTURER FOR ANALYSIS. THE SOFTWARE FLASHCARD THAT WAS INITIALLY SHIPPED WITH THE HAND HELD IN QUESTION WAS KEPT BY THE SITE, AND THE NEW FLASHCARD THAT WAS SENT WITH THE REPLACEMENT HAND HELD WAS RETURNED INSTEAD. PRODUCT ANALYSIS IS CURRENTLY UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 678293

    Patients

    Seq Age Sex Outcome Treatment
    1