BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MECHANICAL HEART VALVE

    MDR report key: 1924339 · Received December 7, 2010

    Report

    Report Number
    2648612-2010-00071
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, A PT WITH A HISTORY OF RHEUMATIC HEART DISEASE AND SEVERE MITRAL STENOSIS UNDERWENT MITRAL VALVE REPLACEMENT SURGERY. POSTOPERATIVELY, THE PT EXPERIENCED SHORTNESS OF BREATH ON EXERTION. AN ECHOCARDIOGRAM REVEALED AN ELEVATED GRADIENT AND INDICATED AN IMPEDED LEAFLET. THE PT UNDERWENT THROMBOLYSIS AND HAS SHOWN SIGNS OF IMPROVEMENT. THE DEVICE REMAINS IMPLANTED AND ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM MECHANICAL HEART VALVE STANDARD HEART VALVE LWQ ST. JUDE MEDICAL PUERTO RICO, INC. (CS) 31M-101

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R