BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANCOCK AKA MEDTRONIC

    MDR report key: 101069 · Received June 26, 1997

    Report

    Report Number
    MW1011574
    Event Type
    Malfunction
    Date Received
    June 26, 1997
    Date of Event
    May 28, 1997
    Report Date
    June 17, 1997
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS REMOVED FROM PT DUE TO STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANCOCK AKA MEDTRONIC Implant STANDARD AORTIC HEART VALVE LWR MEDTRONIC INC. 242/23MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 *