BEUDAMED
    FDA Adverse Event Other Summary report: N

    THORATEC VAD SYSTEM BLOOD PUMP

    MDR report key: 230259 · Received June 28, 1999

    Report

    Report Number
    2916595-1999-00006
    Event Type
    Other
    Date Received
    June 28, 1999
    Date of Event
    June 1, 1999
    Report Date
    June 2, 1999
    Manufacturer
    THORATEC LABORATORIES CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT WITH BOTH LEFT AND RIGHT VENTRICULAR ASSIST DEVICES (VADS) IMPLANTED FOR ALMOST TWO MONTHS HAD BOTH VADS REMOVED AND REPLACED DUE TO MULTIPLE CEREBROVASCULAR EMBOLIC EVENTS. THE EVENTS HAD OCCURRED ON 4/18, 4/25 AND 5/5/99. THE VADS WERE EXAMINED UPON EXPLANT; THROMBI WERE FOUND IN THE RVAD, BUT NOT THE LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VAD SYSTEM BLOOD PUMP Implant VENTRICULAR ASSIST DEVICE DSQ THORATEC LABORATORIES CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention