BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 5770180 · Received July 5, 2016

    Report

    Report Number
    3004582654-2016-00021
    Event Type
    Injury
    Date Received
    July 5, 2016
    Date of Event
    June 7, 2016
    Report Date
    June 7, 2016
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    H100004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    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). PATIENT REMAINS SUPPORTED BY THE DEVICE. G8: ADVERSE EVENT TERM: ISCHEMIC CVA.

    Description of Event or Problem · 0

    THE SITE CONTACTED (B)(6) ON (B)(6) 2016 AS THE PATIENT EXHIBITED RIGHT SIDE HEMIPARESIS. CT SCAN REVEALED LEFT MCA INFARCT. THE SITE CONTINUES TO MONITOR. THERE WERE TWO DEPOSITS IN THE PUMP MEASURING 1MM X 1MM AND NEITHER CHANGED OR DISAPPEARED THROUGHOUT THE EVENT. THE SITE REPORTED THAT THE VAD PERFORMED APPROPRIATELY THROUGHOUT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422493 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Life Threatening| R