BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE BIOPROSTHETIC HEART VALVE

    MDR report key: 581816 · Received March 2, 2005

    Report

    Report Number
    2025587-2005-00023
    Event Type
    Malfunction
    Date Received
    March 2, 2005
    Date of Event
    January 10, 2005
    Report Date
    January 31, 2005
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THE VALVE WAS ABANDONED AT IMPLANT DUE TO BLEEDING SEEN IN THE NCC/ RCC AREA OF THE VALVE DURING THE CASE. THE DEVICE WAS INTRA-OPERATIVELY REPLACED WITH NO SUBSEQUENT PT COMPLICATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BIOPROSTHETIC HEART VALVE BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES, INC. 995 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention