BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE MEDTRONIC

    MDR report key: 11783550 · Received April 27, 2021

    Report

    Report Number
    11783550
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    April 14, 2021
    Report Date
    April 21, 2021
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 1

    A (B)(6) YO W/ PMH HFREF (30%) ICM S/P HEARTWARE 2018, PRESENTED WITH INCREASED LDH AND DARK URINE, ELEVATED POWERS AND VAD FLOWS. PT FOUND TO HAVE PUMP FAILURE FOR PRESUMED THROMBUS. WAS TAKEN TO OPERATING ROOM ON 04/14/2021 FOR PUMP EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631677 HEARTWARE MEDTRONIC HEARTWARE LVAD DSQ

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization