BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLVIN-GALLOWAY MITRAL RING

    MDR report key: 3010288 · Received March 16, 2013

    Report

    Report Number
    3010288
    Event Type
    Malfunction
    Date Received
    March 16, 2013
    Date of Event
    January 18, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    KRH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH A HISTORY OF CORONARY ARTERY DISEASE STATUS POST CORONARY ARTERY BYPASS GRAFTING AND MITRAL VALVE RECONSTRUCTION IN 2008. POSTOPERATIVELY THE MITRAL VALVE DEVELOPED A LEAK SO HE WAS REFERRED TO THORACIC/CARDIAC SURGERY FOR EVALUATION. HE REPORTS PROGRESSIVELY WORSENING SHORTNESS OF BREATH, ORTHOPNEA AND EXERTIONAL FATIGUE NOW AFFECTING HIS FUNCTIONAL STATUS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?REDO MITRAL VALVE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111073 COLVIN-GALLOWAY MITRAL RING RING, ANNULOPLASTY KRH MEDTRONIC UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR