BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 7451864 · Received April 23, 2018

    Report

    Report Number
    3004582654-2018-00015
    Event Type
    Injury
    Date Received
    April 23, 2018
    Date of Event
    March 24, 2018
    Report Date
    April 23, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH(MANUFACTURER). PUMP CHANGE OCCURRED (B)(6) 2018 AFTER THROMBUS DETECTED IN PUMP. PATIENT WAS WITHDRAWN FROM SUPPORT (B)(6) 2018. ON (B)(6) 2018, PATIENT BECAME BRADYCARDIAC AND HYPERTENSIVE, PASSING AWAY THE NEXT DAY. ADVERSE EVENT TERM: ISCHEMIC / HEMORRHAGIC STROKE.

    Description of Event or Problem · 0

    THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS TO REPORT THAT A PATIENT SUPPORTED BY AN EXCOR BLOOD PUMP IN THE LVAD CONFIGURATION DETECTED THROMBUS IN THE PUMP AND BECAME CONCERNED FOR THROMBOEMBOLISM. EEG MONITORING SHOWED NO SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295084 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 2.5 YR Life Threatening