BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3243858 · Received July 23, 2013

    Report

    Report Number
    3243858
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 22, 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

    PT PRESENTED WITH LOW INR, POWER SPIKES AND HIGH LDH. INITIALLY THERE WAS NO EVIDENCE OF CLOT SO MEDICAL MANAGEMENT BY ANTICOAGULATION WAS ATTEMPTED. LDH ROSE AGAIN (B)(6), PT UNDERWENT A HMII EXCHANGE. A SMALL CLOT WAS FOUND IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343260 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1