BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHISPERVIEW

    MDR report key: 3861022 · Received May 21, 2014

    Report

    Report Number
    3861022
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    March 4, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS SCHEDULE FOR AN IMPLANTATION OF A BIVENTRICULAR DEFIBRILLATOR. WITH THE LEFT VENTRICULAR LEAD IMPLANTED, THERE WAS SOME DIFFICULTY REMOVING A WHISPER VIEW. DURING REMOVAL OF THE WHISPER WIRE THE WIRE BROKE INSIDE THE LEAD. UNDER FLUOROSCOPY ABOUT 2MM OF WIRE CAN BE SEEN INSIDE THE LEAD. THERE WAS NO HARM TO THE PATIENT. THE DEVICE WAS CONNECTED TO THE LEAD WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303902 WHISPERVIEW WIRE, GUIDE DQX BOSTON SCIENTIFIC CORPORATION 4648 16149799

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR