BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 261077 · Received February 4, 2000

    Report

    Report Number
    261077
    Event Type
    Death
    Date Received
    February 4, 2000
    Date of Event
    September 14, 1999
    Report Date
    February 3, 2000
    Manufacturer
    ST. JUDE MEDICAL, INS.
    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 CORONARY ARTERY DISEASE WITH MITRAL VALVE REGURGITATION. THE REPLACEMENT VALVE WAS REMOVED AS A RESULT OF MITRAL VALVE REGURGITATION. DURING THE PROCEDURE, THE PT HAD SEVERE HYPOTENSION AND BRADYCARDIA REQUIRING CPR. THE PT EXPIRED IN THE OPERATING ROOM. THERE WAS ENDOCARDITIS OF THE VALVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death