BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2853441 · Received November 30, 2012

    Report

    Report Number
    2853441
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    July 4, 2012
    Report Date
    November 30, 2012
    Manufacturer
    SYNCARDIA CARDIOWEST
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HYPERTENSIVE EPISODE CAUSING FAULT ALARM.UNRESPONSIVE TOANTIHYPERTENSIVES. RESPIRATORY DISTRESS- SENT TO ICU. IMMEDIATELYINTUBATED. NIPRIDE AND PROPOFOL DRIPS. CXR- PULMONARY EDEMA. DIURESEDAND RAPIDLY RECOVERED AND ABLE TO BE EXTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LVAD DSQ SYNCARDIA CARDIOWEST

    Patients

    Seq Age Sex Outcome Treatment
    1