BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE

    MDR report key: 75574 · Received February 6, 1997

    Report

    Report Number
    75574
    Event Type
    Death
    Date Received
    February 6, 1997
    Date of Event
    November 13, 1996
    Report Date
    November 18, 1996
    Manufacturer
    2CI
    Product Code
    DWB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VALVE HOUSING BECAME SEPARATED FROM HEART PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE Implant HEARTMATE 1000A DWB 2CI 1000A *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death