BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 4538071 · Received February 18, 2015

    Report

    Report Number
    3003761017-2015-00068
    Event Type
    Death
    Date Received
    February 18, 2015
    Date of Event
    January 16, 2015
    Report Date
    January 16, 2015
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FREEDOM DRIVERS HAVE BEEN RETURNED TO SYNCARDIA FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED AND PRELIMINARY RESULTS INDICATED THAT THE DRIVERS PERFORMED AS INTENDED AND THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. WHEN THE INVESTIGATION HAS BEEN COMPLETED, THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    THE REPORTED ISSUE INVOLVES THREE FREEDOM DRIVERS AND ARE REPORTED UNDER THREE SEPARATE MEDICAL DEVICE REPORTS: FREEDOM DRIVER SN (B)(4) (MFR REPORT # 3003761017-2015-00067); FREEDOM DRIVER SN (B)(4) (MFR REPORT # 3003761017-2015-00068); AND FREEDOM DRIVER SN (B)(4) (MFR REPORT # 3003761017-2015-00069). THE CUSTOMER REPORTED THAT ALL THREE FREEDOM DRIVERS EXHIBITED FAULT ALARMS WHILE SUPPORTING A PT AT HOME. THE CUSTOMER ALSO REPORTED THAT THE PT, WHO WAS AT HOME, WAS UNCONSCIOUS WITH LABORED BREATHING WHEN THE FIRST DRIVER EXHIBITED A FAULT ALARM. THE PT WAS TRANSPORTED TO THE EMERGENCY ROOM AT (B)(6) AND SWITCHED TO THE SECOND FREEDOM DRIVER. THE SECOND FREEDOM DRIVER EXHIBITED A FAULT ALARM AND THE PT WAS SWITCHED TO THE THIRD FREEDOM DRIVER. THIRD FREEDOM DRIVER EXHIBITED A FAULT ALARM. THE PT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117444 SYNCARDIA FREEDOM DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR