BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC

    MDR report key: 354587 · Received October 3, 2001

    Report

    Report Number
    MW1022997
    Event Type
    Injury
    Date Received
    October 3, 2001
    Date of Event
    September 28, 2001
    Report Date
    October 1, 2001
    Manufacturer
    THERMOCARDIO SYSTEMS, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/20/01: THE VOLUNTARY REPORT MISIDENTIFIES THE MFR AS THERMOCARDIO SYSTEMS INSTEAD OF THORATEC CORP. WHILE THERMOCARDIO SYSTEMS AND THORATEC LABS MERGED IN 2/01 TO BECOME THORATEC CORP, THE DEVICE IN QUESTION WAS NOT MFG BY THE FORMER THERMOCARDIO SYSTEMS, BUT BY THE FORMER THORATEC LABS. THE SERIAL NUMBER OF THE DEVICE IS MISIDENTIFIED. THE CATALOG NUMBER IN THE REPORT, "45384," IS NOT A THORATEC CATALOG NUMBER. THE LOT NUMBER IN THE REPORT, "P/N 500990006005," IS THE PART NUMBER OF THE LABEL ON THE DEVICE.

    Description of Event or Problem · 1

    LEFT VENTRICULAR ASSIST DEVICE IMPLANTED. THE ELECTRICAL CONVERTOR ON THE COMPRESSION DEVICE FAILED. MANUAL PUMPING BY HAND WAS INITIATED. THE COMPRESSION DEVICE WAS REPLACED. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44531 THORATEC LEFT VENTRICULAR ASSIST DEVICE DSQ THERMOCARDIO SYSTEMS, INC. THORATEC 2600 P/N 500990006005

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R