BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3233917 · Received July 16, 2013

    Report

    Report Number
    2916596-2013-00862
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 24, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING WITH THE IMPLANTED DEVICE. 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2013 WITH VOMITING, ELEVATED LIVER ENZYMES, AND TEA COLORED URINE. PATIENT HAS A HISTORY OF CHRONIC VENTRICULAR TACHYCARDIA AND CHRONIC LYMPHOCYTIC LEUKEMIA. PATIENT WAS ON TRIPLE THERAPY ANTICOAGULATION. AN ECHO WAS PERFORMED, WHICH SHOWED INCOMPLETE LEFT VENTRICLE UNLOADING AND ELEVATED LDH AND PLASMA FREE HGB. THE PATIENT WAS ADMINISTERED MEDICATION AND A TEMPORARY VENTRICULAR ASSIST DEVICE WAS PLACED. A PUMP EXCHANGE WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328265 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 123818

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention