BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 446040 · Received February 28, 2003

    Report

    Report Number
    2916596-2003-00007
    Event Type
    Malfunction
    Date Received
    February 28, 2003
    Date of Event
    October 23, 2002
    Report Date
    February 27, 2003
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER 11 MONTHS OF SUPPORT, A THORATEC VENTRICULAR ASSIST DEVICE (VAD) PATIENT EXHIBITED SYMPTOMS OF RIGHT HEART FAILURE. AN ECHO REVEALED TRICUSPID VALVE IMPINGEMENT ON RVAD INLET CANNULA. AT THE TIME OF EVENT, THE PATIENT WAS PARTICIPATING IN THORATEC TLC II HOME DISCHARGE STUDY. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND PLACED ON THE DUAL DRIVE CONSOLE. PATIENT WILL REMAIN HOSPITALIZED UNTIL TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM VENTRICULAR ASSIST DEVICE, INFLOW CANNULA DSQ THORATEC CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention