BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1935453 · Received November 10, 2010

    Report

    Report Number
    2916596-2010-00287
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 20, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR EVAL. THE REPORTED EVENT OF UNK ALARMS WAS CONFIRMED DURING ANALYSIS. THE WHITE POWER CABLE WAS STRIPPED AT THE CONNECTOR END REVEALING A BROKEN INNER CONDUCTOR WITH BURN DAMAGE SEEN ON THE END OF THE CONDUCTOR. THIS SITUATION IS BEING ADDRESSED THROUGH THE MFR'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTIVE NOTICE (29165969/2/10001-C) WAS SENT TO CUSTOMERS. IN ADDITION, TWO POWER MODULE PT CABLES WERE RETURNED AND UPON INSPECTION, BENT PINS WERE REVEALED IN THE WHITE CONNECTOR END OF ONE CABLE. THE BENT PINS CAUSED NOTICEABLE RESISTANCE WHEN MATING THE CONNECTOR OF THE SYSTEM CONTROLLER TO THE POWER MODULE PT CABLE; HOWEVER, CONTINUITY TESTS PERFORMED REVEALED THE CABLE RESISTANCE WAS WITHIN THE NORMAL PARAMETERS. THE SECOND CABLE WAS FOUND TO BE INTACT AND FREE OF DAMAGE WITH NO PROBLEMS FOUND. 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT WHILE AT HOME, THE PT REPORTED HAVING A BENT PIN IN THE WHITE CONNECTOR LEAD OF THE POWER MODULE PT CABLE. A REPLACEMENT POWER MODULE PT CABLE WAS SENT TO THE PT'S HOME. A FEW DAYS LATER, THE PT EXPERIENCED ALARMS WHEN CONNECTED TO HIS SYSTEM CONTROLLER WHILE USING THE REPLACEMENT POWER MODULE PT CABLE. THE MFR'S TECHNICAL SUPPORT DEPARTMENT SUGGESTED REPLACING BOTH THE SYSTEM CONTROLLER AND POWER MODULE PT CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 90859

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other