BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC BLOOD SYSTEMS, INC.

    MDR report key: 16030 · Received July 21, 1994

    Report

    Report Number
    16030
    Event Type
    Injury
    Date Received
    July 21, 1994
    Date of Event
    February 24, 1994
    Report Date
    March 3, 1994
    Manufacturer
    MEDTRONIC BLOOD SYSTEMS, INC.
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A VALVE WAS INSERTED DURING SURGERY. ROUTINE CHEST CLOSURE WAS STARTED WHEN THE PATIENT'S BLOOD PRESSURE BEGAN TO FALL. THE PATIENT'S CHEST WAS RE-OPENED AND THE ECHO SHOWED THAT THE VALVE LEAFLETS WERE NOT OPENING WITH EVERY HEART BEAT. THE ATRIUM WAS RE-OPENED AND THE VALVE TURNED. THE PATIENT WAS CLOSED AND COMING OFF PUMP AGAIN WHEN THE SAME PROBLEM WAS NOTED. THE PATIENT WAS AGAIN RE-OPENED AND THAT VALVE WAF REMOVED AND REPLACED WITH A DIFFERENT BRAND. THIS ENTIRE EPISODE REQUIRED RE-OPENING THE CHEST AND ATRIUM X2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC BLOOD SYSTEMS, INC. Implant MITRAL VALVE FJK MEDTRONIC BLOOD SYSTEMS, INC. M7700

    Patients

    Seq Age Sex Outcome Treatment
    1 48 * Required Intervention