BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA XT

    MDR report key: 3861979 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01728
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 7, 2014
    Report Date
    October 23, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD OUTPUT WAS DECREASED TO 1 VOLT AND THE LV LEAD REMAINS IN USE. THERE HAS BEEN NO MENTION OF ABDOMINAL STIMULATION SINCE THE REPROGRAMMING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEY WERE SUFFERING FROM DIAPHRAGMATIC STIMULATION. THIS IS THEIR THIRD DEVICE AND THEY HAVE ALWAYS HAD A SLIGHT PROBLEM WITH THIS. THE PATIENT STATED THAT THEY ARE GETTING SHOCKED AT LEAST 50% OF THE TIME, WHICH IS MAKING IT DIFFICULT FOR THEM TO SLEEP AND EVEN TALK. THE DEVICE CURRENTLY REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337509 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC, INC. DTBA2D1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention