BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 538987 · Received August 11, 2004

    Report

    Report Number
    538987
    Event Type
    Death
    Date Received
    August 11, 2004
    Date of Event
    August 8, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TWO DAYS BEFORE EVENT DATE. DETAILS FOR REASON OF ADMISSION NOT AVAILABLE. CARDIAC CATH RESULTS: LEFT CIRCUMFLEX STENTED WITH 2 TAXUS STENTS, LAD STENTED WITH TAXUS. RETURNED TO HOSP POST FALL OF 15 FEET; DEVELOPED CHEST PAIN. TO CATH LAB; LAD STENT CLOSED. REOPENED WITH STENT, 2 STENTS PLACED IN CIRCUMFLEX. VERY UNSTABLE DURING PROCEDURE; CARDIAC ARREST AND UNABLE TO RESUSCITATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC TAXUS DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC NOT AVAILABLE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death