BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL LINQ

    MDR report key: 4120722 · Received August 15, 2014

    Report

    Report Number
    4120722
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 15, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    ORIGINALLY IMPLANTED IN THE SPRING OF THIS YEAR. A FEW MONTHS LATER THE DEVICE WAS FOUND TO BE MIGRATING OUT OF BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491420 REVEAL LINQ DETECTOR, ALARM, ARRHYTHMIA DSI MEDTRONIC, INC. LNQ11 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *