BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC LABORATORIES CORP.

    MDR report key: 225286 · Received May 25, 1999

    Report

    Report Number
    225286
    Event Type
    Injury
    Date Received
    May 25, 1999
    Date of Event
    February 19, 1999
    Report Date
    May 25, 1999
    Manufacturer
    THORATEC LABORATORIES CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DOCUMENTED CEREBROVASCULAR ACCIDENT ON 2/19/1999 - LEFT MIDDLE CEREBRAL ARTERY AND OCCIPITAL AREA BY CT SCAN. LEFT SIDE WEAKNESS, RESIDUAL REQUIRING REHABILITATION. DOCUMENTED CEREBROVASCULAR ACCIDENT ON 4/14/1999 - CT SCAN INDICATED NEW AREA OF INFARCT RIGHT CAUDATE. ON EXPLANT OF DEVICE LARGE CLOT FOUND INSIDE BLOOD SAC AND IN OUTLET CANNULA OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC LABORATORIES CORP. Implant VENTRICULAR ASSIST DEVICE DSQ THORATEC LABORATORIES CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| S