BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER (EUROPE)

    MDR report key: 2260332 · Received September 1, 2011

    Report

    Report Number
    2916596-2011-00377
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. APPROXIMATELY 2.5 YEARS POST-IMPLANT, THE PATIENT NOTICED A SMALL TEAR IN THE BLACK POWER LEAD OF THE SYSTEM CONTROLLER. A FEW HOURS LATER, HE OBSERVED SMOKE COMING FROM THE AFFECTED AREA. THE PATIENT DISCONNECTED HIMSELF FROM THE SYSTEM CONTROLLER AND CALLED EMERGENCY SERVICES. THE AMBULANCE ARRIVED 10 MINUTES LATER AND CONNECTED THE PATIENT TO THE BACKUP SYSTEM CONTROLLER. THE PATIENT DID NOT REPORT THIS INFORMATION TO THE IMPLANTING CLINIC; HOWEVER, DURING A ROUTINE VISIT, THE PATIENT MENTIONED THE EVENT AND THAT IT HAD OCCURRED APPROXIMATELY THREE WEEKS PRIOR.

    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 53 YR Other