BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1924721 · Received December 9, 2010

    Report

    Report Number
    2916596-2010-00339
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 10, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PERFUSIONIST REPORTED THAT THERE WAS SUSPECTED PUMP THROMBUS AND NOTICED THE PUMP STOPPED BRIEFLY. A DECISION WAS MADE TO EXCHANGE SYSTEM CONTROLLERS TO SEE IF THERE WAS ANY DIFFERENCE. THE BACK UP SYSTEM CONTROLLER WAS PLACED ON THE PT AND RAN FOR A SHORT PERIOD OF TIME BEFORE ALL VISUAL AND AUDIBLE ALARMS SOUNDED AND THE SYSTEM STOPPED FUNCTIONING BRIEFLY. THE PT WAS THEN SWITCHED TO ANOTHER BACK UP SYSTEM CONTROLLER AND NO FURTHER PROBLEMS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION 103696 93143

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention