BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3981841 · Received August 5, 2014

    Report

    Report Number
    1644487-2014-01941
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 9, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ANALYSIS OF THE HANDHELD WAS COMPLETED ON 08/18/2014. 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 08/18/2014. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD SERIAL CABLE CONNECTION WAS NOT GOOD AND CAUSED INTERMITTENT COMMUNICATION PROBLEMS. IT WAS REPORTED THAT THE SERIAL CABLE WAS NOT ABRADED. THE SITE HAD ANOTHER PROGRAMMING SYSTEM AND INDICATED THAT A NEW PROGRAMMING COMPUTER WAS NOT NEEDED. THE HANDHELD AND FLASHCARD WERE RECEIVED FOR ANALYSIS. ANALYSIS IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458658 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 874809

    Patients

    Seq Age Sex Outcome Treatment
    1