BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3960038 · Received July 17, 2014

    Report

    Report Number
    2916596-2014-01210
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    May 18, 2014
    Report Date
    June 20, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS ADMITTED FOR GASTROINTESTINAL (GI) BLEEDING. THE PT WAS GIVEN 12 UNITS OF RED BLOOD CELLS (RBCS), 5 UNITS OF FRESH FROZEN PLASMA (FFP), AND 5 UNITS OF PLATELETS. LINEAR LESIONS WERE DISCOVERED WHICH WOULD PUT THE PT AT HIGH RISK FOR BLEEDING, THOUGH THE PT WAS NOT BLEEDING AT THE TIME. A CLOT WAS REPORTEDLY FOUND IN THE STOMACH AND ERYTHROMYCIN AND ADMINISTERED TO DISSOLVE THE CLOT. THE PT CONTINUES TO BE MONITORED AND NO FURTHER BLEEDING HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417998 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 106171

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention