BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT

    MDR report key: 21762314 · Received April 3, 2025

    Report

    Report Number
    21762314
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    March 30, 2025
    Report Date
    March 31, 2025
    Manufacturer
    ABBOTT
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT IS A HEARTMATE 2 LVAD PT (DOI: (B)(60 2019) THAT RECEIVED A HEART TRANSPLANT ON (B)(6) 2025 AT MUSC. HE WAS NOTED TO HAVE AN OUTFLOW GRAFT THROMBUS ON (B)(6) 2023 WITH NO SIGNIFICANT OCCLUSION OR STENOSIS. ON (B)(6) 2025 HE WAS ADMITTED FOR A NEW SHORT TO SHIELD AND TRANSFERRED TO MUSC BUT RETURNED TO PRISMA FOR A SHORT TO SHIELD REPAIR BY ABBOTT ENGINEERS. ON (B)(6) 2025 HE WAS ADMITTED DUE TO LOW FLOW ALARMS, INCREASING MURAL WALL THROMBUS IN OUTFLOW GRAFT AND ELEVATED LDH. TRANSFERRED TO MUSC (B)(6) 2025. LOH STABLE. MULTIPLE LOW FLOW ALARMS. ASYMPTOMATIC WHEN AMBULATING. HEPARIN INFUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847975 ABBOTT HEARTMATE 2 LVAD DSQ ABBOTT

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention| H| L