BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2678256 · Received August 1, 2012

    Report

    Report Number
    2678256
    Event Type
    Injury
    Date Received
    August 1, 2012
    Date of Event
    June 14, 2012
    Report Date
    August 1, 2012
    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 WITH EVIDENCE OF PUMP THROMBUS VIA ECHO, ELEVATED PFH, ELEVATED LDH, AMBER URINE, AND MOTOR POWER SPIKES. DESPITE TREATMENT WITH HEPARIN, LDH AND PFH CONTINUED TO WORSEN, AND HGB DECREASED. PT TO OR ON (B)(6) 2012 FOR PUMP EXCHANGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1