BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 3830729 · Received May 6, 2014

    Report

    Report Number
    2916596-2014-00591
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON LVAD SUPPORT WITH THE PUMP. NO FURTHER INFO 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROXIMATELY 1.5 YEARS POST-IMPLANT, IT WAS REPORTED THAT THE PT WAS READMITTED INTO THE HOSPITAL FOR DYSPNEA AND HEMOLYSIS. THE PATIENT'S LDH WAS >1900, BILIRUBIN WAS DECREASING AND PLASMA FREE HEMOGLOBIN WAS NORMAL. AN ECHOCARDIOGRAM WAS PERFORMED AND INDICATED THAT THE LEFT VENTRICLE WAS UNLOADING WELL WITH NO AORTIC VALVE OPENING. A CHEST CT SCAN INDICATED NO PULMONARY CONGESTION AND FURTHER EVAL OF THE PT IS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270993 HEARTMATE II LVAS, EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106016 118826

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention