BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1744544 · Received June 30, 2010

    Report

    Report Number
    2916596-2010-00153
    Event Type
    Death
    Date Received
    June 30, 2010
    Date of Event
    March 1, 2010
    Report Date
    June 1, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVALUATION. 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 (LVAD). THE VAD COORDINATOR REPORTED THAT THE PATIENT WAS FOUND UNRESPONSIVE. THE PATIENT'S CAUSE OF DEATH WAS NOT REPORTED TO THE MANUFACTURER. THE DEVICE WAS EXPLANTED BY THE STATE MEDICAL EXAMINER AND IS CURRENTLY BEING HELD BY THE HOSPITAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 1355 66705

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death