BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2465300 · Received February 21, 2012

    Report

    Report Number
    2916596-2012-00154
    Event Type
    Death
    Date Received
    February 21, 2012
    Date of Event
    January 20, 2012
    Report Date
    January 24, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. 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

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE PERFUSIONIST REPORTED THAT THE PATIENT EXPIRED. THE PUMP WAS SUSPECTED TO BE CLOTTED.

    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. 104911 109742

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death