BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2843479 · Received November 19, 2012

    Report

    Report Number
    2916596-2012-01080
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 23, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LVAD WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. 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. THE VAD COORDINATOR REPORTED THAT THE PT PRESENTED WITH HEART FAILURE SYMPTOMS. HEMOLYSIS WAS ALSO DOCUMENTED. THE PUMP WAS EXCHANGED, THOUGH THE ORIGINAL INFLOW AND OUTFLOW GRAFTS WERE PRESERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 85140

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention