BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 7690394 · Received July 16, 2018

    Report

    Report Number
    3004582654-2018-00038
    Event Type
    Injury
    Date Received
    July 16, 2018
    Date of Event
    June 13, 2018
    Report Date
    July 16, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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). AT THE TIME OF THE ADVERSE EVENT, NO DEPOSITS WERE REPORTED IN THE PUMP. THE PATIENT WAS IMPLANTED ON (B)(6) 2018 AND HAD THREE PUMP CHANGES FOR DEPOSITS WITH THE LAST BEING (B)(6) 2018. ADVERSE EVENT TERM: HEMORRHAGIC CVA.

    Description of Event or Problem · 0

    ON JUNE 22, 2018, THE SITE CONTACTED BERLIN HEART (B)(4) TO REPORT A PATIENT SUPPORTED IN LVAD CONFIGURATION OF THE EXCOR BLOOD PUMP HAD A HEMORRHAGIC CVA ON (B)(6) 2018. PATIENT EXHIBITED AN ALTERED MENTAL STATUS AND FUNCTIONAL WEAKNESS IN THE LEFT SIDE OF THE BODY. A HEAD CT FOUND THE BLEEDING AND ANTICOAGULATION THERAPY WAS ABOVE TARGET RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533019 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Life Threatening