BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER (EUROPE)

    MDR report key: 1935417 · Received November 11, 2010

    Report

    Report Number
    2916596-2010-00285
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    August 2, 2010
    Report Date
    October 13, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. UPON ANALYSIS OF THE RETURNED SYSTEM CONTROLLER, THE REPORTED EVENT OF THE PUMP STOPPING WAS CONFIRMED. VISUAL INSPECTION REVEALED A BROKEN STRAIN RELIEF AT THE HOUSING END OF THE BLACK POWER LEAD AND SEVERAL CONDUCTORS WERE FOUND TO BE SEVERED WITHIN THE LEAD AT THE POINT OF THE DAMAGE. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATION FROM MANUFACTURING OR QA SPECIFICATIONS. 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). THE PT WAS SEEN AT HOME AND A BRIEF PUMP STOP, WHICH RESOLVED SPONTANEOUSLY, WAS REPORTED. AT THE SAME TIME, THE BLACK POWER LEAD OF THE SYSTEM CONTROLLER BECAME HOT AT THE POINT OF A BREAK IN THE BEND RELIEF ON THE SYSTEM CONTROLLER HOUSING END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER (EUROPE) LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 102140 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention