BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3884370 · Received June 19, 2014

    Report

    Report Number
    1644487-2014-01539
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 27, 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

    Description of Event or Problem · 1

    THE HANDHELD DEVICE AND SOFTWARE FLASHCARD WERE RETURNED TO THE MANUFACTURER FOR 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 PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. 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 NURSE WAS HAVING INTERMITTENT COMMUNICATION ISSUES WITH HER PROGRAMMING SYSTEM. THE WAND SHOWED DATA TRANSMISSION AND THE HANDHELD SHOWED THE INTERROGATION PROGRESS BAR, BUT THEN AN ERROR MESSAGE APPEARED AND THE INTERROGATION FAILED. THE WAND BATTERY WAS REPLACED, THE HANDHELD DEVICE WAS FULLY CHARGED, AND A HARD RESET WAS PERFORMED; HOWEVER, THE ISSUES DID NOT RESOLVE. ANOTHER PROGRAMMING SYSTEM WAS ABLE TO SUCCESSFUL COMMUNICATE WITH THE PATIENTS¿ DEVICES. IT WAS DETERMINED THAT THERE WAS NO ISSUE WITH THE WAND. FURTHER FOLLOW-UP REVEALED THAT THE HANDHELD¿S SCREEN WORKED INTERMITTENTLY. THE SCREEN WOULD FREEZE AND AT ONE POINT PIXILATED OVER AND WENT BLACK. A HARD RESET WAS PERFORMED AND THE SOFTWARE FLASHCARD WAS RESEATED; HOWEVER, THE SCREEN ISSUE CONTINUED TO OCCUR. IT WAS NOTED THAT THE SERIAL CABLE CONNECTION AT THE BASE OF THE HANDHELD WAS LOOSE. THE SERIAL CABLE NEEDED TO BE PLACED IN A SPECIFIC ORIENTATION IN ORDER TO COMMUNICATE. THE HANDHELD DEVICE HAS NOT BEEN RETURNED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361886 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1063524

    Patients

    Seq Age Sex Outcome Treatment
    1