BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 261073 · Received February 3, 2000

    Report

    Report Number
    261073
    Event Type
    Death
    Date Received
    February 3, 2000
    Date of Event
    November 30, 1999
    Report Date
    February 1, 2000
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD A MITRAL VALVE REPLACEMENT IN 1999 SECONDARY TO RHEUMATIC MITRAL STENOSIS. THE REPLACEMENT VALVE WAS REMOVED AS A RESULT OF SEVERE MITRAL REGURGITATION SECONDARY TO MITRAL VALVE DEHISCENCE. ANOTHER VALVE WAS IMPLANTED. THE PT EXPIRED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL MECHANICAL HEART VALVE LWQ ST. JUDE MEDICAL, INC. 31MS-601 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death