BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRA TRANSCATHETER PACEMAKER SYSTEM

    MDR report key: 6255852 · Received January 17, 2017

    Report

    Report Number
    6255852
    Event Type
    Malfunction
    Date Received
    January 17, 2017
    Date of Event
    December 15, 2016
    Report Date
    December 30, 2016
    Manufacturer
    MEDTRONIC VASCULAR , INC.
    Product Code
    PNJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NO GOOD THRESHOLD, OR CAPTURE. WHEN THE PHYSICIAN WAS TRYING TO PLACE THE MICRA LEADLESS PACEMAKER, THERE WAS NO CAPTURE. THE DEVICE WAS REMOVED, AND A NEW DEVICE WAS INSERTED. THE NEW DEVICE SEATED WELL AND SHOWED GOOD CAPTURE AND IMPEDENCE. NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39322 MICRA TRANSCATHETER PACEMAKER SYSTEM LEADLESS PACEMAKER PNJ MEDTRONIC VASCULAR , INC. MC1VR01

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other