BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3200392 · Received July 1, 2013

    Report

    Report Number
    1644487-2013-02002
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL #, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INCLUDED AN INCORRECT SERIAL NUMBER FOR THE SUSPECT MEDICAL DEVICE. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION. MANUFACTURE DATE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INCLUDED AN INCORRECT MANUFACTURE DATE FOR THE SUSPECT MEDICAL DEVICE. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION.

    Description of Event or Problem · 1

    THE HANDHELD ANALYSIS WAS COMPLETED ON (B)(6) 2013. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE HANDHELD COULD NOT COMPLETE THE SCREEN ALIGNMENT UTILITY DURING THE INITIAL SETUP PROCESS. THE CAUSE FOR THE ANOMALY IS ASSOCIATED WITH DEBRIS THAT WAS TRAPPED UNDER THE CASE. ONCE THE DISPLAY WAS CLEANED, NO FURTHER ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. ANALYSIS OF THE FLASHCARD WAS COMPLETED ON (B)(4) 2013. 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

    THE HANDHELD DEVICE AND SOFTWARE FLASHCARD WERE RETURNED ON (B)(6) 2013 AND ARE PENDING ANALYSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT A HANDHELD DEVICE WAS CONTINUALLY FREEZING, THIS WAS TYPICALLY RESOLVED WITH A HARD RESET, BUT NOW THE TOUCH SCREEN NO LONGER RESPONDS EITHER. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. THE PRODUCT HAS NOT BEEN RETURNED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300262 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1063524

    Patients

    Seq Age Sex Outcome Treatment
    1