BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 5365067 · Received January 13, 2016

    Report

    Report Number
    3004582654-2015-00024
    Event Type
    Injury
    Date Received
    January 13, 2016
    Date of Event
    October 24, 2015
    Report Date
    October 24, 2015
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    H100004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PER FDA INSTRUCTION, RESUBMITTING EMDR. THIS MDR WAS PREVIOUSLY SUBMITTED ON NOVEMBER 23, 2015 WITH ALL THREE ACKNOWLEDGEMENTS(RECEIPT OR MDN, CDRH RECEIPT, STATUS OF EMDR STATING PASS) RECEIVED BY NOVEMBER 24, 2015, HOWEVER EMDR WENT TO PRE-PRODUCTION ACCOUNT INADVERTENTLY. EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH (MANUFACTURER). THE PATIENT HAD A HISTORY OF ACUTE MYOCARDITIS AND WAS IMPLANTED WITH THE EXCOR PEDIATRIC ON (B)(6) 2015 AFTER ECMO SUPPORT SINCE (B)(6) 2014. PATIENT REMAINS SUPPORTED BY THE DEVICE. G8: ADVERSE EVENT TERM: HEMORRHAGIC CVA

    Description of Event or Problem · 0

    ON (B)(6) 2015 THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS TO REPORT THAT ON (B)(6) 2015, A PATIENT WHO WAS BEING SUPPORTED WITH AN EXCOR PEDIATRIC LVAD HAD DECREASED MOVEMENT OF HIS LEFT EXTREMITIES. A CT WAS PERFORMED AT APPROXIMATELY 11:00PM SHOWING A HEMORRHAGIC STROKE. THE PATIENT BECAME LETHARGIC, ANTICOAGULATION WAS STOPPED AND THE PATIENT WAS BROUGHT TO THE OPERATING ROOM ON (B)(6) 2015 AT 5:00AM FOR AN EXTERNAL VENTRICULAR DRAIN. PRIOR TO THE EVENT, THE PATIENT HAD PERSISTENT DEPOSITS IN THE PUMP AND THE UNFRACTIONATED HEPARIN LEVELS WERE BEING KEPT AT 0.8 - 0.9 WHILE ON A HEPARIN DRIP. THE PUMP WAS FILLING AND EJECTING NORMALLY, PUMP FUNCTION DID NOT CHANGE DURING THE EVENT. THE PERFUSIONIST REPORTED THE PATIENT TOLERATED THE PROCEDURE WELL. HE REMAINS INTUBATED AND IS MOVING AROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23240 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Required Intervention