BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3913306 · Received July 3, 2014

    Report

    Report Number
    1644487-2014-01696
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE WAS HAVING INTERMITTENT COMMUNICATION ISSUES WITH THE PROGRAMMING SYSTEM. THE NURSE WAS REQUIRED TO REPOSITION THE PROGRAMMING WAND IN ORDER TO SUCCESSFULLY PERFORM INTERROGATIONS. THE WAND BATTERY WAS CONFIRMED TO BE FUNCTIONING PROPERLY. TROUBLESHOOTING WAS PERFORMED AND ISSUES WERE FOUND WITH BOTH THE HANDHELD DEVICE AND PROGRAMMING WAND. THE SPECIFIC ISSUE WITH THE DEVICES COULD NOT BE DETERMINED. THE PROGRAMMING SYSTEM HAS NOT BEEN RETURNED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE HANDHELD AND FLASHCARD WERE RETURNED FOR PRODUCT ANALYSIS. NO ANOMALIES ASSOCIATED WITH THE HANDHELD WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD AND FLASHCARD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389445 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1