BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1935443 · Received November 10, 2010

    Report

    Report Number
    2916596-2010-00291
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    July 29, 2010
    Report Date
    October 13, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR EVAL AND THE REPORTED EVENT WAS CONFIRMED. DURING FUNCTIONAL TESTING OF THE RETURNED SYSTEM CONTROLLER, NO ALARM CONDITIONS WERE OBSERVED; HOWEVER, WHEN THE BLACK POWER LEAD WAS MANEUVERED AT THE CONNECTOR END DURING TESTING, THE SYSTEM REPORTED POWER CABLE DISCONNECT ALARMS AND FOLLOWED BY A RED BATTERY ALARM INDICATING LOW VOLTAGE TO THE SYSTEM, CONSISTENT WITH THE REPORTED EVENT. 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 MFR'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 MFR 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 LOW VOLTAGE ALARMS AND OTHER UNIDENTIFIED ALARMS. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE PT REMAINS 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 CORP. 103696

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other