BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 7956749 · Received October 11, 2018

    Report

    Report Number
    3004582654-2018-00051
    Event Type
    Injury
    Date Received
    October 11, 2018
    Date of Event
    September 18, 2018
    Report Date
    October 11, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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: ISCHEMIC CVA.

    Description of Event or Problem · 0

    ON (B)(6) 2018, THE SITE CONTACTED BERLIN HEART (B)(4) TO REPORT A PATIENT SUPPORTED IN LVAD CONFIGURATION OF THE EXCOR BLOOD PUMP HAD AN ISCHEMIC CVA INVOLVING THE MEDIAL CEREBRAL ARTERY ON (B)(6) 2018. DURING PHYSICAL THERAPY, THE PATIENT WAS NOTED TO TURN THEIR HEAD THEN BECOME RIGID. PATIENT WAS INTUBATED AND SEDATED AFTER BEING RETURNED TO ICU. PRIOR TO THE CVA, THE PATIENT WAS ASYMPTOMATIC AND WAS RECEIVING LMWH: 18 MG BID ; ASPIRIN: 35 MG BID ; DIPYRIDAMOLE: 25 MG Q6HRS. ANTICOAGULATION WAS IN TARGET RANGE. THE CLINIC USED THE SAME DRUGS AND DOSES AFTER THE CVA. PATIENT DID REQUIRE A PUMP CHANGE ON (B)(6) 2018 DUE TO THROMBUS IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797552 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Other