BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MASTERS SERIES MECHANICAL HEART VALVE

    MDR report key: 1970497 · Received January 20, 2011

    Report

    Report Number
    2648612-2011-00006
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    October 19, 2010
    Report Date
    January 20, 2011
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, INC. (SC)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, FOLLOWING THE IMPLANTATION OF THIS VALVE, THE PT EXPERIENCED RECURRENT CEREBRAL INFARCTIONS. THE VALVE WAS EXPLANTED APPROX 7 1/2 YEARS POSTOPERATIVELY AND REPLACED WITH A 29 MM SJM EPIC BIOPROSTHESIS. DURING THE EXPLANT PROCEDURE, A SMALL AMOUNT OF THROMBUS OR FIBRIN WAS OBSERVED ON THE ATRIAL SURFACE OF THE VALVE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM MASTERS SERIES MECHANICAL HEART VALVE ROTATABLE HEART VALVE LWQ ST. JUDE MEDICAL, PUERTO RICO, INC. (SC) 33MJ-501

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R