BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 4898725 · Received July 1, 2015

    Report

    Report Number
    3003761017-2015-00211
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 17, 2015
    Report Date
    June 17, 2015
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ALSO REPORTED THAT THE PATIENT IS FINE AND THERE WAS NO PERMANENT IMPACT TO HIS HEALTH. THE FREEDOM DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT'S WIFE REPORTED LAST WEEK THAT SHE HEARD A STRANGE NOISE, LOOSE PARTS INSIDE, COMING FROM THE DRIVER WHILE SUPPORTING THE PATIENT AT HOME. THE CUSTOMER ADVISED THE PATIENT'S WIFE THAT THE DRIVER NEEDED TO COME BACK IN FOR EXCHANGE URGENTLY FOR SAFETY REASONS. THE CUSTOMER ALSO REPORTED THAT THE PATIENT'S WIFE REFUSED TO RETURN THE DRIVER TO THE CLINIC. THE CUSTOMER ALSO REPORTED THAT YESTERDAY THE PATIENT'S WIFE REPORTED THAT THE PATIENT COUGHED AND THEN THE DRIVER SUDDENLY STOPPED FOR SOME SECONDS. THE PATIENT FELT DIZZY AND THEN THE DRIVER STARTED AGAIN BUT GAVE A CONTINUOUS ALARM. THE CUSTOMER ALSO REPORTED THAT THE PATIENT FELT BETTER AND HIS WIFE SWITCHED TO THE BACKUP DRIVER WITHOUT ANY ISSUE AND AFTERWARDS THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429574 SYNCARDIA FREEDOM DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR