BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC

    MDR report key: 488408 · Received October 9, 2003

    Report

    Report Number
    488408
    Event Type
    Injury
    Date Received
    October 9, 2003
    Date of Event
    May 24, 2002
    Report Date
    September 26, 2003
    Manufacturer
    THORATEC
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2002, A PAIR OF THORATEC VENTRICULAR ASSIST DEVICES (VAD) WERE IMPLANTED INTO PT. A MONTH LATER PT WAS CONVERTED OVER TO THE PORTABLE DRIVER (THORATEC TLC-II) WHICH LOGGED SEVERAL ALARMS OVER THE FOLLOWING TWO MONTHS. (STAFF CONTINUED TO WORK WITH THE THORATEC REPS FOR ANALYSIS OF THE SITUATION). PT USED TLC-II DURING THE DAY, THE DUAL DRIVE CONSOLE AT NIGHT. 3 MONTHS LATER, THERE WAS A DRAMATIC AIR LEAK COMING FROM THE RIGHT VAD. ATTEMPTS TO CORRECT THE LEAK WERE UNSUCCESSFUL AND VAD HAD TO BE REPLACED IN THE OR UNDER STERILE PROCEDURE. PT TRANSPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE DSQ THORATEC P-VAD *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention