BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II SYSTEM CONTROLLER, EU

    MDR report key: 1654350 · Received April 7, 2010

    Report

    Report Number
    2916596-2010-00073
    Event Type
    Death
    Date Received
    April 7, 2010
    Date of Event
    March 21, 2010
    Report Date
    March 22, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT EXPIRED ON (B) (6) 2010. SYSTEM CONTROLLERS, (B) (4) ARE NOT THE ORIGINAL EQUIPMENT FOR THIS PATIENT. THE TWO SYSTEM CONTROLLERS BELONGED TO A DIFFERENT PATIENT BEFORE BEING PROVIDED TO THIS PATIENT FOR USE. SYSTEM CONTROLLER (B) (4) WAS IN USE BY THE PATIENT AT THE TIME OF THE EVENT, PRIOR TO BEING EXCHANGED. AN ATTEMPT TO DOWNLOAD THE HISTORY OF THIS SYSTEM CONTROLLER WAS UNSUCCESSFUL AS THE SYSTEM CONTROLLER WOULD NOT COMMUNICATE WITH THE POWER MODULE. SYSTEM CONTROLLER (B) (4) WAS USED TO REPLACE (B) (4). THE HISTORY OF (B) (4) REVEALED APPROXIMATELY 17 HOURS OF CONTINUOUS FLOW ALARMS. THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE SYSTEM CONTROLLER AND EXPLANTED PUMP FOR ANALYSIS. ALL OTHER EQUIPMENT FOR THIS PATIENT WAS CONFISCATED BY THE POLICE DEPARTMENT AND WILL HELD UNTIL FURTHER NOTICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. APPROXIMATELY 21 MONTHS POST-IMPLANT, THE PATIENT WAS AT HOME AND NOT FEELING WELL ALL DAY AND COLLAPSED IN THE EVENING WHILE CONNECTED TO BATTERIES. EMERGENCY SERVICE WAS CALLED BY THE PATIENT'S WIFE AND EMERGENCY SERVICES CONTACTED THE IMPLANTING HOSPITAL FOR ADVICE. THE SYSTEM CONTROLLER WAS EXCHANGED BASED ON THE DISCUSSION AND THE PATIENT WAS TRANSPORTED TO A NEARBY HOSPITAL. THE PATIENT WAS REPORTED TO BE UNCONSCIOUS DURING THE ENTIRE TIME AND EXPIRED APPROXIMATELY 17 HOURS AFTER THE SYSTEM CONTROLLER EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER, EU LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103692 84133

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death