BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC HEARTWARE HVAD

    MDR report key: 14397662 · Received May 12, 2022

    Report

    Report Number
    MW5109675
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    April 16, 2022
    Report Date
    May 10, 2022
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    117
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6) IS A (B)(6) MALE WITH STAGE D SYSTOLIC HEART FAILURE DUE TO NON-ISCHEMIC CARDIOMYOPATHY S/P HEARTWARE LVAD IMPLANTED ON (B)(6) 2019 AT (B)(6) HOSPITAL IN (B)(6) AS BRIDGE TO TRANSPLANT, G6PD DEFICIENCY, OBESITY, HTN, AND GOUT ADMITTED (B)(6) 2022 FROM CLINIC FOR AKI AFTER METOLAZONE DOSE OVER THE WEEKEND AND PERSISTENT HIGH WATT ALARMS NOW S/P HW TO HM3 (B)(6) 2022 LEFT THORA APPROACH. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388284 MEDTRONIC HEARTWARE HVAD VENTRICULAR (ASSIST) BYPASS DSQ MEDTRONIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Hospitalization