BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3854325 · Received June 6, 2014

    Report

    Report Number
    1644487-2014-01428
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 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
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD CONSTANTLY FREEZES, EVEN AFTER PERFORMING A HARD RESET. TROUBLESHOOTING WAS PERFORMED WHICH DID NOT RESOLVE THE ISSUE. THE PHYSICIAN WAS PROVIDED A NEW PROGRAMMING COMPUTER. THE HANDHELD AND FLASHCARD HAVE NOT BEEN RECEIVED FOR ANALYSIS TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE HANDHELD AND FLASHCARD WERE RECEIVED FOR ANALYSIS. ANALYSIS OF THE HANDHELD WAS COMPLETED ON 11/20/2014. 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. AN ANALYSIS WAS PERFORMED ON THE CRADLE AND NO ANOMALIES WERE IDENTIFIED IN ITS ABILITY TO PROVIDE POWER TO THE HANDHELD. THE CRADLE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS OF THE FLASHCARD WAS COMPLETED ON 11/20/2014. 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
    333009 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1