BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1942006 · Received November 8, 2010

    Report

    Report Number
    2916596-2010-00279
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 12, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF POWER CABLE DISCONNECT AND YELLOW BATTERY ALARMS WAS CONFIRMED AND REPRODUCED DURING ANALYSIS. THE BLACK POWER CABLE WAS FOUND TO HAVE COMPROMISED INNER CONDUCTORS AT THE CONNECTOR END. MOVEMENT OF THE BLACK POWER CABLE AT THE CONNECTOR END WHEN THE WHITE POWER CABLE WAS DISCONNECTED FOR POWER EXCHANGE RESULTED IN POWER CABLE DISCONNECT AND LOW BATTERY ALARMS. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS SYSTEM CONTROLLER SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THIS SITUATION IS BEING ADDRESSED THROUGH THE MANUFACTURER'S CORRECTIVE/PREVENTIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/1001-C) WAS SENT TO CUSTOMERS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PATIENT WAS EXPERIENCING POWER CABLE DISCONNECT ALARMS AND YELLOW BATTERY ALARMS. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE EVENT WAS RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention