BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE III

    MDR report key: 6600510 · Received May 31, 2017

    Report

    Report Number
    6600510
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Date of Event
    May 3, 2017
    Report Date
    May 26, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD VENTRICULAR ASSIST DEVICE (VAD) IMPLANTATION A FEW MONTHS AGO AND HE WAS DISCHARGED HOME A FEW WEEKS LATER. PATIENT WAS READMITTED A MONTH LATER WITH EVIDENCE OF A GI BLEED. PATIENT REQUIRED TWO UNITS OF BLOOD. PATIENT HAD APPROPRIATE RECOVERY OF BLOOD VOLUME AND WAS DISCHARGED HOME FIVE DAYS LATER. THE PATIENT IS ON ANTICOAGULANT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383474 HEARTMATE III VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other CARDIAC DRUGS