BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MECHANICAL HEART VALVE

    MDR report key: 1841247 · Received September 10, 2010

    Report

    Report Number
    2648612-2010-00054
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    May 18, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED 21 YEARS POSTOPERATIVELY, THE VALVE WAS EXPLANTED DUE TO INGROWTH OF PANNUS. A 21MM SJM REGENT VALVES WAS IMPLANTED. ADDITIONAL 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) 21A-101

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R