BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 5990318 · Received September 30, 2016

    Report

    Report Number
    3004582654-2016-00034
    Event Type
    Injury
    Date Received
    September 30, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 9, 2016
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    H100004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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). FOLLOWING DISCUSSIONS WITH THE PHYSICIANS, THE PARENTS ELECTED TO REMOVE SUPPORT FROM THE PATIENT ON (B)(6) 2016 FOLLOWING COMPLICATIONS UNRELATED TO THIS EVENT. ADVERSE EVENT TERM: ISCHEMIC CVA.

    Description of Event or Problem · 0

    THE SITE CONTACTED BHI CLINICAL AFFAIRS (CA) ON (B)(6) 2016 TO REPORT THE PATIENT HAD LOCALIZED SEIZURES. A CT SCAN REVEALED A SUSPECTED AREA OF ISCHEMIC STROKE, BUT NOT CONCLUSIVE. THE PUMP ON THE PATIENT HAD SOME SMALL DEPOSITS, SO THE SITE DECIDED TO CHANGE THE PUMP. THE PUMP WAS CHANGED WITHOUT INCIDENT. THE SITE REPORTED THAT THE PUMP SUPPORTED THE PATIENT APPROPRIATELY THROUGHOUT THE EVENT WITH NO UNTOWARD EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640999 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Life Threatening