BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2092434 · Received May 2, 2011

    Report

    Report Number
    1644487-2011-00960
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 4, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUR CONSULTANT IN (B)(4) WAS CONTACTED BY A VNS TREATING PHYSICIAN REPORTING THAT THEIR HANDHELD COMPUTER WAS NOT WORKING. IT WAS REPORTED THAT THE HANDHELD WAS FREEZING AND HE COULD NOT COMPLETE THE PROGRAMMING OF PATIENTS. OUR CONSULTANT WENT TO THE SITE AND COMPLETED THE SOFTWARE UPGRADE FROM VERSION 7.1 TO VERSION 8.0 UNFORTUNATELY, THIS DID NOT RESOLVE THE PROBLEM. THE CONSULTANT TRIED TO PROGRAM A PATIENT USING THE SAME PROGRAMMER BUT HAD THE SAME ISSUES. IT WAS REPORTED THAT THE MAIN PROBLEM IS THAT WHEN THEY TRIED TO CLICK ON ANY ICON, THE HANDHELD DOES NOT REGISTER, AND THEREFORE, DOES NOT MOVE ONTO THE NEXT SCREEN. REPORTED IF YOU PUSH THE ICON QUITE HARD, IT DOES REGISTER, HOWEVER, CONTINUALLY DOING THIS COULD CAUSE DAMAGE TO THE SCREEN. THIS ONLY WORKS ON THE FIRST TWO SCREENS AND THERE COMES A POINT WHERE NO MATTER WHAT YOU DO, THE HANDHELD DOES NOT REGISTER THAT AN ICON IS BEING PRESSED. THE 9V BATTERY IN THE WAND WAS CHANGED AND RULED OUT. MANUFACTURER IS PENDING RECEIPT OF THE HANDHELD FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 678292

    Patients

    Seq Age Sex Outcome Treatment
    1