BEUDAMED
    FDA Adverse Event Other Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 260573 · Received January 25, 2000

    Report

    Report Number
    2916596-2000-00001
    Event Type
    Other
    Date Received
    January 25, 2000
    Date of Event
    December 24, 1999
    Report Date
    December 27, 1999
    Manufacturer
    THORATEC LABORATORIES 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

    A PT HAD BEEN SUPPORTED WITH BIVENTRICULAR ASSIST DEVICES (LEFT VENTRICULAR ASSIST DEVICE AND RIGHT VENTRICULAR ASSIST DEVICE) FOR SIX MONTHS WHEN PT BEGAN TO EXHIBIT SOME SIGNS OF NEUROLOGICAL COMPROMISE. EXAMINATION OF THE LEFT VENTRICULAR ASSIST DEVICE SHOWED THROMBUS FORMATION ALONG THE INFLOW AND OUTFLOW PORTION OF THE BLOOD SAC AND EDGES OF THE HOUSING. THE LEFT VENTRICULAR ASSIST DEVICE WAS EXPLANTED AND REPLACED. THE PT RECOVERED WELL AFTER THE VENTRICULAR ASSIST DEVICE.

    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 LABORATORIES CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention