BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3152564 · Received June 5, 2013

    Report

    Report Number
    2916596-2013-00717
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LVAD WAS SUCCESSFULLY EXCHANGED AND THE PATIENT REMAINS ONGOING WITHOUT ANY FURTHER ISSUE REPORTED. THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT AFTER 1 MONTH AND 10 DAYS OF SUPPORT ON THE LVAD, THE PATIENT'S TARGET INTERNATIONAL NORMALIZED RATIO (INR) FELL OUT OF RANGE. THE PATIENT DEVELOPED HEART FAILURE SYMPTOMS AND ELEVATED LEVELS OF LACTATE DEHYDROGENASE (LDH). THE PATIENT WAS ALSO REPORTED TO HAVE A HISTORY OF GASTROINTESTINAL (GI) BLEEDING. A DECISION WAS MADE BY THE HOSPITAL TO EXCHANGE THE PATIENT'S PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247665 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 124141

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention