BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2951106 · Received February 8, 2013

    Report

    Report Number
    2951106
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    March 19, 2012
    Report Date
    February 8, 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

    PATIENT HAD MULTIPLE EPISODES OF GI BLEED, REQUIRING LOW ANTICOAGULATION. HE DEVELOPED AN ISCHEMIC STROKE WITH HEMORRHAGIC TRANSFORMATION. PUMP HAD LOW FLOWS AND HIGH POWER, EPISODES OF TIA - DECISION MADE TO EXCHANGE PUMP AND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54998 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1