BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK MODIFIED ORIFICE HEART VALVE

    MDR report key: 172908 · Received June 15, 1998

    Report

    Report Number
    172908
    Event Type
    Injury
    Date Received
    June 15, 1998
    Date of Event
    March 12, 1998
    Report Date
    June 3, 1998
    Manufacturer
    MEDTRONIC CARDIAC SURGERY
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANTED THE DEVICE. NOTICED TEAR IN VALVE. REMOVED VALVE AND REPLACED IT WITH ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANCOCK MODIFIED ORIFICE HEART VALVE Implant HEART VALVE LWQ MEDTRONIC CARDIAC SURGERY MODEL/SIZE: 250/21 MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other| R 03/12/1998