BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4099990 · Received September 18, 2014

    Report

    Report Number
    1644487-2014-02374
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDHELD IS BROKEN. IT WAS REPORTED THAT THERE ARE WHITE LINES APPEARING ON THE SCREEN AND IT IS UNABLE TO BE USED. IT WAS ALSO REPORTED THAT THE STYLUS WILL NOT WORK. IT WAS REPORTED THAT NO REPORTED TRAUMA OR POWER RUSH OCCURRED. A NEW PROGRAMMING TABLET WAS PROVIDED TO THE NURSE PRACTITIONER AND THE HANDHELD WAS RECEIVED FOR ANALYSIS. ANALYSIS IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED HANDHELD DEVICE AND SOFTWARE FLASHCARD WAS COMPLETED. A VISUAL ANALYSIS OF THE HANDHELD WAS ABLE TO VERIFY THAT THE DISPLAY HAD 3 ROWS OF MISSING (DEAD) PIXELS. THE DEAD PIXELS HAD NO IMPACT ON THE DEVICE PERFORMANCE. ALSO DURING THE ANALYSIS, IT WAS IDENTIFIED THAT THE HANDHELD WAS RECEIVED WITH THE LOCK BUTTON IN THE LOCKED POSITION. SINCE THE LOCK BUTTON WAS LOCKED, THE HANDHELD BUTTONS AND TOUCHSCREEN WERE UNRESPONSIVE. ONCE THE LOCK BUTTON WAS MOVED TO THE UNLOCKED POSITION NO ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. 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
    578761 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1063524

    Patients

    Seq Age Sex Outcome Treatment
    1