BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE

    MDR report key: 8608789 · Received May 6, 2019

    Report

    Report Number
    8608789
    Event Type
    Injury
    Date Received
    May 6, 2019
    Date of Event
    April 30, 2019
    Report Date
    May 1, 2019
    Manufacturer
    HEARTWARE INC
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A 44M W/BRAIN ANEURYSM WITH COILING, DVT AND PE S/P IVC FILTER, MI (B)(6) 2016 AND CARDIOGENIC SHOCK REQUIRING (ECMO) S/P HW LVAD HW (B)(6) 2016 AS BTD AND ICD, HEMORRHAGIC CVA, GI BLEEDS, CHRONIC SUPPRESSION FOR LVAD INFECTION ADMITTED WITH HIGH POWER ALARMS AND HEMOLYSIS, S/P OPERATING ROOM FOR PUMP EXCHANGE FOR PUMP THROMBOSIS. A 44M HX OF BRAIN ANEURYSM S/P COILING WHO HAD A DVT/PE COMPLICATED BY SHOCK REQUIRING ECMO AND EVENTUALLY HW LVAD IN 2016 AS BTD. POST-VAD COURSE WAS COMPLICATED BY HEMORRHAGIC CVA, GIB, MULTIPLE INFECTIONS ON CHRONIC SUPPRESSION WITH ANTIBIOTICS WHO PRESENTS AS A TRANSFER FROM AN OUTSIDE HOSP WITH HIGH WATT ALARMS ON LVAD AND HEMOLYSIS AND WENT TO OPERATING ROOM ON (B)(6) 2019 FOR LVAD EXCHANGE FOR PUMP THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378333 HEARTWARE LVAD DSQ HEARTWARE INC HVAD 15870951-9298

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| O