BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVANOVA

    MDR report key: 6714141 · Received July 14, 2017

    Report

    Report Number
    6714141
    Event Type
    Malfunction
    Date Received
    July 14, 2017
    Date of Event
    May 15, 2017
    Report Date
    July 6, 2017
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE VALVE WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494221 LIVANOVA HEART-VALVE LWR SORIN GROUP USA, INC. A-40878

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR