BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2010609 · Received March 1, 2011

    Report

    Report Number
    2916596-2011-00088
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 4, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS STILL IN USE. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE TRANSPLANT COORDINATOR SUSPECTED A THROMBUS OR OCCLUSION IN THE PUMP. THE PT WAS ADMITTED TO THE ER COMPLAINING OF "DIZZINESS AND INABILITY TO WALK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 90806

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention