BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2021367 · Received February 8, 2011

    Report

    Report Number
    2916596-2011-00065
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    August 17, 2010
    Report Date
    January 11, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE REPORTED CUTS IN THE SYSTEM CONTROLLER BLACK POWER LEAD WERE CONFIRMED DURING ANALYSIS. VISIBLE MECHANICAL DAMAGE CAUSED BY AN UNKNOWN SOURCE WAS ALSO NOTED. DURING FUNCTIONAL TESTING OF THE SYSTEM CONTROLLER, IT WAS FOUND THAT THE CONTROLLER WOULD NOT POWER UP. FURTHER EVALUATION REVEALED THAT THE MAIN CURRENT REGULATOR (VCC REGULATOR), WHICH IS THE MAIN POWER SOURCE FOR ALL OF THE COMPONENTS ON THE MAIN SYSTEM CONTROLLER BOARD, WAS NOT FUNCTIONING. THIS RESULTED IN THE SYSTEM CONTROLLER NOT POWERING UP DURING ANALYSIS. UPON FURTHER EVALUATION, COMPROMISED INNER CONDUCTORS IN THE CUT AREAS OF THE BLACK POWER LEAD WERE FOUND. THE COMPROMISED INNER CONDUCTORS OF THE BLACK POWER LEAD MAY HAVE CONTRIBUTED TO THE MAIN CONTROLLER BOARD COMPONENTS NOT FUNCTIONING; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. 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 (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE SYSTEM CONTROLLER BLACK POWER LEAD HAS 2 CUTS IN THE INSULATION, AND A RED HEART ALARM OCCURRED WITH THE CONTROLLER. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE ISSUE WAS RESOLVED. THE PATIENT REMAINS ONGOING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other