BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3003914 · Received March 12, 2013

    Report

    Report Number
    2916596-2013-00274
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS ONGOING ON LVAD SUPPORT. 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

    PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PATIENT WAS ADMITTED FOR NAUSEA/VOMITING AND WAS FOUND TO HAVE HEMOLYSIS, PEAK LDH 1812, AND PLASMA FREE 198. THERE ARE NO SIGNS OF A PUMP KINK OR OBSTRUCTION ON THE CT ANGIOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103738 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 107264

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention