BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3042165 · Received April 4, 2013

    Report

    Report Number
    2916596-2013-00385
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 7, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON LVAD SUPPORT AND NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH ELEVATED LACTATE DEHYDROGENASE (LDH) LEVELS, SPEED DROPS, AND EPISODES OF WATTAGE ELEVATION TO 10 WATTS. THE PATIENT REPORTEDLY DENIED ANY DYSPNEA, HEMATURIA OR LETHARGY. A RECENT ECHOCARDIOGRAM (ECHO) AND CARDIAC CATHETERIZATION REVEALED GOOD PUMP FUNCTION/LEFT VENTRICLE UNLOADING AND NORMAL RIGHT ATRIAL PRESSURES. HEPATIC AND RENAL FUNCTIONS WERE REPORTEDLY NORMAL. THE PATIENT WAS REPORTED AS HAVING REDUCED RESPONSE TO COUMADIN WITH DIFFICULTY TO ACHIEVE ACCEPTABLE INTERNATIONAL NORMALIZED RATIO (INR) LEVELS. PATIENT CONTINUES TO BE MONITORED AND REMAINS AT TRANSPLANT STATUS 1B.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138505 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 115175

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention