BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 326849 · Received April 6, 2001

    Report

    Report Number
    326849
    Event Type
    Death
    Date Received
    April 6, 2001
    Date of Event
    March 30, 2001
    Report Date
    April 5, 2001
    Manufacturer
    ST JUDE MEDICAL
    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 PRESENTED TO E/R WITH RESPIRATORY DISTRESS AND ACUTE PULMONARY EDEMA. PT WENT INTO CARDIO-PULMONARY ARREST. RESUSCITATION EFFORTS WERE NOT SUCCESSFUL, LASTING ONE HOUR. PT HAD SILZONE AORTIC VALVE IMPLANT. IT HAS NOT BEEN DETERMINED IF THE VALVE CAUSED OR CONTRIBUTED TO PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15576 ST. JUDE MEDICAL AORTIC VALVE LWQ ST JUDE MEDICAL 23AHPS-605 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death