BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MCS

    MDR report key: 14955240 · Received July 8, 2022

    Report

    Report Number
    14955240
    Event Type
    Injury
    Date Received
    July 8, 2022
    Date of Event
    February 17, 2022
    Report Date
    March 10, 2022
    Manufacturer
    MEDTRONIC
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    117
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT EXPERIENCED UNEXPLAINED HIGH POWER AND LOW FLOW ON PUMP WITHOUT ANY CLEAR PHYSIOLOGICAL EXPLANATION, SO THEREFORE WAS LISTED FOR HEART TRANSPLANT. PUMP WAS IMPLANTED AT OSH IN 2018. A 49 YEARS OLD MALE WITH DILATED CMY S/P LVAD IN 2018, DLI WITH MSSA ON CHRONIC ANTIBIOTIC THERAPY. DIABETES WHO IS NOW TRANSFERRED FROM RGB WITH CONCERN INITIALLY FOR PUMP THROMBOSIS WHICH WAS RULED OUT WAS LATER DISCHARGED AND HAD A LOW FLOW ON PUMP WITHOUT ANY CLEAR PHYSIOLOGICAL EXPLANATION WHICH ALSO CAUSED HYPOTENSION AND AKI EPISODE. GIVEN NO CLEAR EXPLANATION OF THESE EVENTS SO THEREFORE DECISION WAS MADE TO LIST FOR HEART TRANSPLANTATION AS UNOS STATUS 2 FOR DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2104084 MEDTRONIC MCS HVAD HEARTWARE DSQ MEDTRONIC HW32467

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Hospitalization| R