BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL INC.

    MDR report key: 152745 · Received February 24, 1998

    Report

    Report Number
    152745
    Event Type
    Injury
    Date Received
    February 24, 1998
    Date of Event
    February 9, 1998
    Report Date
    February 24, 1998
    Manufacturer
    ST JUDE MEDICAL, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT W/EBSTEINS ANOMALY HAD ROUTINE FLUOROSCOPY 2/5; IT WAS NOTED THE SUPERIOR TILTING DISK LEAFLET OF THE ST. JUDE'S MEDCIAL MITRAL VALVE PROSTHESIS WAS NOT MOVING AND APPEARED FROZEN, WHILE THE MORE INFERIOR TILTING DISK LEAFLET WAS MOVING. PT WAS ADMITTED FOR D/C OF COUMADIN AND MAINTENANCE ON HEPARIN DRIP, FOLLOWED BY REMOVAL OF THE PROSTHETIC VALVE AND REPLACEMENT W/A PORCINE VALVE. ADMITTED 2/6 AND PROCEDURE ON 2/9: TERTIARY STERNOTOMY FOR REPLACEMENT OF THE TRICUSPID VALVE PROSTHESIS; EXCISION OF FRESHLY THROMBOSED ST. JUDE MEDICAL MITRAL VALVE PROSTHESIS IN THE SUPRAVALVULAR TRICUSPID POSITION; IMPLANTATION OF 33MM LOW-PRESSURE CARPENTIER-EDWARDS PORCINE BIO-PROSTHESIS IN THE SUPRAVALVULAR TRICUSPID POSITION. PERFORMED UNDER TEMPORARY CARDIOPULMONARY BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL INC. Implant MECHANICAL HEART VALVE LWQ ST JUDE MEDICAL, INC. 6625LP 33MM-101 *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| L| R