BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC

    MDR report key: 4532258 · Received December 15, 2014

    Report

    Report Number
    4532258
    Event Type
    Other
    Date Received
    December 15, 2014
    Date of Event
    September 5, 2014
    Report Date
    December 12, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    LWR
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC MOSAIC AORTIC VALVE SIZE 25 MM WAS IMPLANTED. A TEE IMMEDIATELY POST IMPLANTATION SHOWED THE VALVE WAS NOT EFFECTIVE. THE VALVE WAS EXPLANTED AND ANOTHER WAS IMPLANTED. THE COMPANY WAS NOTIFIED AND THE DEFECTIVE VALVE WAS RETURNED TO THE COMPANY THROUGH THE COMPANY REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821642 MEDTRONIC NONE LWR MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other