BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 3020558 · Received March 21, 2013

    Report

    Report Number
    2916596-2013-00310
    Event Type
    Death
    Date Received
    March 21, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 (LVAD). THE VAD COORDINATOR REPORTED THAT THE PATIENT EXPIRED AND WOULD LIKE TO RETURN PUMP FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE PATIENT WAS DISCHARGED ON (B)(6). HE HAD MULTISYSTEM ORGAN FAILURE AND GI BLEEDING AND THE PUMP CLOTTED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117122 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM DSQ: VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 119468

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death