BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3930337 · Received July 11, 2014

    Report

    Report Number
    3930337
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    March 8, 2014
    Report Date
    July 10, 2014
    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

    ON (B)(6) PT SAW ALARM ON VAD ASSOCIATED W/ LIGHTHEADEDNESS & SYNCOPE. LDH ELEVATED >1300 WHICH CONTINUED TO RISE, DARK URINE, ELEVATED P-HEMOGLOBIN, DETERMINED PT HAD VAD THROMBUS W/ HEMOLYSIS. PT NOT CANDIDATE FOR EXCHANGE D/T RV FAILURE. D/C HOSPICE.PRIMARY COD: CIRCULATORY: OTHER, SPECIFY - END STAGE ACUTE ON CHRONIC SYSTOLIC HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406042 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1