BEUDAMED
    FDA Adverse Event Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2882422 · Received December 20, 2012

    Report

    Report Number
    2882422
    Date Received
    December 20, 2012
    Date of Event
    August 30, 2012
    Report Date
    December 17, 2012
    Manufacturer
    THORATEC CORPORATION
    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

    PATIENT BECAME HYPOTENSIVE 3 HRS POST IMPLANT IN ICU, HAD ARRHYTHMIAS, AND LOW FLOW READING ON PUMP, WENT INTO CARDIAC ARREST REQUIRING CPR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death