BEUDAMED
    FDA Adverse Event Death Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 8209656 · Received January 2, 2019

    Report

    Report Number
    3004582654-2019-00001
    Event Type
    Death
    Date Received
    January 2, 2019
    Date of Event
    November 30, 2018
    Report Date
    January 2, 2019
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    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). G8: ADVERSE EVENT TERM: HEMORRHAGIC CVA.

    Description of Event or Problem · 0

    THE DISTRIBUTOR CONTACTED BERLIN HEART (B)(4) ON DECEMBER 5TH, 2018 TO REPORT THAT A PATIENT SUPPORTED IN THE LVAD CONFIGURATION WITH THE EXCOR BLOOD PUMP HAD A HEMORRHAGIC STROKE AND DIED ON (B)(6) 2018. THERE WILL BE NO MORE INFORMATION ON THIS CASE BECAUSE OF THE NEW (B)(6) DATA PRIVACY LAW. BERLIN HEART IS IN NEGOTIATION WITH THE (B)(4) DISTRIBUTOR TO GET A WRITTEN AGREEMENT, TO DETERMINE WHICH DATA WILL BE NEEDED FOR FUTURE CASES; UNTIL THEN MOST PATIENT DATA FROM (B)(6) WILL NOT BE TRANSMITTED TO BERLIN HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Death| L