BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3780723 · Received April 22, 2014

    Report

    Report Number
    2916596-2014-00540
    Event Type
    Injury
    Date Received
    April 22, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING WITH THE IMPLANTED DEVICE. NO FURTHER INFO 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE HOSP REPORTED THAT THE PT IS CURRENTLY BE TREATING FOR HEMOLYSIS. THE RADIOLOGIST DESCRIBED A MURAL THROMBUS IN THE OUTFLOW GRAFT CONDUIT. THE PT STOPPED TAKING ANTICOAGULATION MEDICATION FOR A WEEK DUE TO A MISUNDERSTANDING. THE HOSP HAS HIM ON ARGATROBAN, ASPIRIN AND NOW TICAGRELOR. NO INFECTION AT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243647 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 135850

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention