BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2925478 · Received January 22, 2013

    Report

    Report Number
    1644487-2013-00199
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PHYSICIAN'S OFFICE WAS HAVING ISSUES WITH THEIR PROGRAMMING SYSTEM COMMUNICATING WITH VARIOUS PATIENTS, WHICH STARTED A FEW DAYS PRIOR. IT WAS NOTED THAT THE PROGRAMMING SYSTEM WAS NOT PLUGGED INTO THE WALL DURING INTERROGATIONS. THE MANUFACTURER'S CONSULTANT WAS USED HER GOOD WAND WITH THE PHYSICIAN'S HANDHELD AND WAS UNABLE TO COMMUNICATE WITH THE DEMO GENERATOR. THE CONSULTANT'S PROGRAMMING SYSTEM WAS SAID TO BE OPERATING PROPERLY. THE PHYSICIAN'S HANDHELD AND FLASHCARD WERE RETURNED TO THE MANUFACTURER ON (B)(6) 2013 FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED 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 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
    29159 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 874811

    Patients

    Seq Age Sex Outcome Treatment
    1