BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3072892 · Received April 23, 2013

    Report

    Report Number
    3072892
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 19, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUSPECTED PUMP THROMBOSIS LDH 809 PATIENT TAKEN TO CTICU SWAN GANZ PLACED CVP 11, PA 44/19 M 29 CO 5.2 CI 2.63 SVO2 43, TPA 30 MG GIVEN AT 10:26 AM. HM2 EXCHANGED INFLOW THROMBOSIS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175039 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1