BEUDAMED
    FDA Adverse Event Other Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 418490 · Received September 20, 2002

    Report

    Report Number
    2916596-2002-00040
    Event Type
    Other
    Date Received
    September 20, 2002
    Date of Event
    July 11, 2002
    Report Date
    September 20, 2002
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT SUPPORTED WITH BIVENTRICULAR ASSIST DEVICES (LVAD AND RVAD) REQUIRED RVAD REPLACEMENT DUE TO A SMALL LEAK IN THE VAD BLOOD SAC. THERE WAS NO ADVERSE EFFECT ON THE PT, WHO SUBSEQUENTLY RECEIVED A CARDIAC TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM VENTRICULAR ASSIST DEVICE, BLOOD PUMP DSQ THORATEC CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| R