BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 7690392 · Received July 16, 2018

    Report

    Report Number
    3004582654-2018-00037
    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 FROM (B)(6) 2018 AND HAD A PUMP CHANGE ON (B)(6) 2018. PATIENT REMAINS ON SUPPORT. ADVERSE EVENT TERM: HEMORRHAGIC CVA.

    Description of Event or Problem · 0

    ON (B)(6) 2018, THE SITE CONTACTED BERLIN HEART (B)(4) TO REPORT THAT A PATIENT WITH AN EXCOR BLOOD PUMP SUPPORTED IN LVAD CONFIGURATION HAD A HEMORRHAGIC CVA ON (B)(6) 2018. THE PATIENT EXHIBITED AN ALTERED MENTAL STATUS. THE ANTICOAGULATION THERAPY WAS REPORTED TO BE ABOVE TARGET RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533018 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Life Threatening