BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3347021 · Received September 9, 2013

    Report

    Report Number
    2916596-2013-01161
    Event Type
    Injury
    Date Received
    September 9, 2013
    Date of Event
    August 12, 2013
    Report Date
    August 12, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PT. NO FURTHER INFORMATION 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 ON INOTROPIC SUPPORT (MILRINONE) FOR ELEVATED PULMONARY PRESSURES AND A RIGHT HEART CATH WILL BE SCHEDULED. THE PT WAS PLACED ON AGGRENOX, ASPIRIN, COUMADIN WITH INTERNATIONALIZED NORMALIZED RATIO (INR) GOAL OF 2.5-3.5 FOR INCREASED PLASMA FREE HEMOGLOBIN (PFH). THE EXACT PFH WAS NOT SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449848 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 126035

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention