BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC CG FUTURE ANNULOPLASTY RING

    MDR report key: 1952466 · Received December 2, 2010

    Report

    Report Number
    1952466
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 7, 2010
    Report Date
    December 2, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    KRH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY SEVEN (7) WEEKS AGO THE PATIENT UNDERWENT A MINIMALLY INVASIVE REPAIR OF THE MITRAL VALVE. ABOUT A MONTH LATER, THE PATIENT PRESENTED AT A SISTER HOSPITAL FOR WHAT WAS THOUGHT TO BE AN INFECTION AS IT WAS UNCLEAR WHY THE PATIENT WAS SYMPTOMATIC. AT THAT TIME, THE PATIENT ADMITTED TO LIFTING 60-70 LB. CONCRETE BLOCKS A COUPLE OF DAYS AFTER DISCHARGE. IN ADDITION, WHILE DRIVING A TRUCK TO THE STORE, THE PATIENT HIT A CURB AND SUSTAINED A TRAUMA TO THE CHEST FROM THE STEERING WHEEL. THE PATIENT WAS DIAGNOSED WITH SEVERE MITRAL VALVE REGURGITATION AND WENT TO SURGERY FOR REPLACEMENT OF THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC CG FUTURE ANNULOPLASTY RING RING, ANNULOPLASTY KRH MEDTRONIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR