BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2433615 · Received January 10, 2012

    Report

    Report Number
    2916596-2012-00023
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 15, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE SYSTEM CONTROLLER WAS CONNECTED TO THE EQUIPMENT IN THE MANUFACTURER'S LAB. THE REPORT OF INTERMITTENT BEEPING WAS CONFIRMED DURING ANALYSIS. WHEN THE BLACK POWER LEAD WAS CONNECTED TO THE TEST EQUIPMENT, THE PUMP SPEED WAS INTERRUPTED AND THE MOVEMENT OF THE BLACK POWER LEAD AT THE CONNECTOR END RESULTED IN ALARMS WHILE TETHERED TO THE TEST POWER MODULE. INSULATION TESTING OF THE BLACK POWER LEAD REVEALED COMPROMISED INSULATION. THE BLACK POWER LEAD WAS THEN STRIPPED AND COMPROMISED WIRES WERE FOUND AT THE CONNECTOR END AND NEAR THE HOUSING END OF THE CABLE. THIS SITUATION IS BEING ADDRESSED THROUGH THE MANUFACTURER'S CORRECTIVE/PREVENTIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/10001-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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS EXPERIENCING INTERMITTENT BEEPING. THE SYSTEM CONTROLLER WAS EXCHANGED WITH ANOTHER SYSTEM CONTROLLER AND NO FURTHER PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 89671

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other