BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC HALL PROSTHESIS

    MDR report key: 81136 · Received January 17, 1997

    Report

    Report Number
    81136
    Event Type
    Malfunction
    Date Received
    January 17, 1997
    Date of Event
    July 12, 1996
    Report Date
    November 20, 1996
    Manufacturer
    MEDTRONIC CARDIAC SURGERY
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    6 MONTHS PRIOR TO EXPLANT PT EXPERIENCED PERIVALVULAR LEAK. PULMONARY HYPERTENSION AND SEVERE CONGESTIVE HEART FAILURE. REMOVED VALVE WAS COMPLETELY DEHISCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC HALL PROSTHESIS Implant HEART VALVE LWQ MEDTRONIC CARDIAC SURGERY M7700133 *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other PREVIOUS MITRAL VALVE REPLACEMENT OF 1977