BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1950191 · Received December 9, 2010

    Report

    Report Number
    2916596-2010-00335
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 17, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE REPORTED EVENT WAS CONFIRMED. DURING FUNCTIONAL TESTING OF THE SYSTEM CONTROLLER, NO ALARM CONDITIONS WERE OBSERVED. HOWEVER, WHEN THE BLACK POWER LEAD WAS MANEUVERED AT THE CONNECTOR END DURING TESTING, THE POWER MODULE SOUNDED AN AUDIBLE ALARM, CONSISTENT WITH REPORTED EVENT. IN ADDITION, THE SYSTEM REPORTED YELLOW BATTERY ALARMS AND THE VOLTAGE LEVELS ON THE SYSTEM MONITOR VARIED WITH MANIPULATION OF THE BLACK POWER LEAD. THE SYSTEM CONTROLLER WAS DISCONNECTED FROM THE TEST SYSTEM AND UPON INSPECTION OF THE INNER CONDUCTORS AT THE CONNECTOR END OF THE BLACK POWER LEAD, THE BROWN CONDUCTOR THAT MONITORS THE BATTERY VOLTAGE WAS FOUND TO BE SEVERED. THIS SITUATION IS BEING ADDRESSED THROUGH THE MANUFACTURER'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/10001-C) WAS SENT TO CUSTOMERS. NO FURTHER INFO IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT WAS EXPERIENCING RANDOM ALARMS WHICH REPORTEDLY CEASED WHEN THE PT'S POWER MODULE PT CABLE AND SYSTEM CONTROLLER WERE EXCHANGED. THE PT REMAINS ONGOING ON LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED.

    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 UNK Other