BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART MATE II

    MDR report key: 1922915 · Received October 19, 2010

    Report

    Report Number
    1922915
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 25, 2010
    Report Date
    October 7, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS (B)(6) MALE WITH END STAGE ISCHEMIC CARDIOMYOPATHY UNDERWENT PLACEMENT OF A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2010. APPROXIMATELY 2 1/2 WEEKS LATER, HE SUFFERED A NEUROLOGIC EVENT AND DEVELOPED ISCHEMIC CHANGES IN HIS LOWER EXTREMITIES. A BRAIN CT SCAN REVEALED MULTIPLE SHOWER TYPE EMBOLI. THE CARDIAC SURGEON (IN CONJUNCTION WITH MANUFACTURER) NOTED THE LVAD WAS NOT WORKING/HAD A MECHANICAL FAILURE. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2010 FOR EXCHANGE OF THE LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART MATE II LEFT VENTRICULAR ASSIST DEVICE (LVAD) DSQ THORATEC CORPORATION 94349

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R