BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 556832 · Received November 23, 2004

    Report

    Report Number
    556832
    Event Type
    Death
    Date Received
    November 23, 2004
    Date of Event
    November 12, 2004
    Report Date
    November 22, 2004
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RADIOLOGIST INSERTED AN INFERIOR VENA CAVA GREENFIELD FILTER. THE FILTER DID NOT DEPLOY WHEN PLACED INTO INFERIOR VENA CAVA. DEVICE MIGRATED INTO ATRIUM. PATIENT EXPIRED DURING RETRIEVAL ATTEMPT.

    Description of Event or Problem · 1

    THE DFU DOES NOT CONTAIN A STATEMENT REGARDING EXPECTED FREQUENCY OF THE REPORTED EVENT, BUT DOES INCLUDE THE SECTION "POSSIBLE TECHNICAL COMPLICATIONS AND THEIR CAUSES" WHICH ADDRESSES POSSIBLE CAUSES FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC GREENFIELD VENA CAVA FILTER DTK BOSTON SCIENTIFIC CORP. * 6106561

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death