BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 4477165 · Received February 3, 2015

    Report

    Report Number
    2916596-2015-00202
    Event Type
    Injury
    Date Received
    February 3, 2015
    Date of Event
    December 29, 2014
    Report Date
    January 5, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE: 21 DAYS.A ROOT CAUSE FOR THE PATIENT¿S GI BLEED COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON LVAD SUPPORT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT. PLACEHOLDER.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PATIENT STATED HE WAS IN THE CLINIC AROUND 10AM AND FELT FINE. THAT AFTERNOON, AROUND 3PM, HE DEVELOPED EXTREME DIZZINESS, LIGHTHEADEDNESS AND ALMOST PASSED OUT ON 3 OR 4 OCCASIONS. HE HAD 2 BOWEL MOVEMENTS WITH A MODERATE AMOUNT OF DARK TARRY STOOL WITH BRIGHT RED BLOOD MIXED. HE SAYS HE COULD NOT EVEN GET UP, SO EMS WAS CALLED FOR TRANSPORT. THE PATIENT HAD A HIGH INTERNATIONAL NORMALIZED RATIO AND GI BLEEDING REQUIRING 2 UNITS OF FRESH FROZEN PLASMA, AND 1 UNIT PACKED RED BLOOD CELLS (PRBCS) IN THE EMERGENCY ROOM. THE PATIENT RECEIVED A TOTAL OF 5 UNITS OF PRBCS AND THE EVENT WAS DOCUMENTED AS RESOLVED ON (B)(6) 2015. THE PATIENT'S PHYSICIAN NOTED THE RELATIONSHIP TO THE LVAD AS ''POSSIBLY''.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78891 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R