BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART SYSTEM

    MDR report key: 7107916 · Received December 12, 2017

    Report

    Report Number
    7107916
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    September 16, 2016
    Report Date
    December 6, 2017
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HE WAS IN PHYSICAL THERAPY IN THE AFTERNOON AND WHILE LYING ON HIS BACK WITH HIS KNEES UP, THE THERAPIST WAS MASSAGING HIS HIP AREA. HE "BLACKED OUT" MOMENTARILY AND AT THAT TIME THE FREEDOM DRIVER HAD A TEMPORARY FAULT ALARM THAT RESOLVED SPONTANEOUSLY. DRIVING HOME FROM THERAPY, HE DIDN'T FEEL RIGHT AND FELT A FLUTTERING IN HIS CHEST. THE DEVICE HAD THREE MORE TEMPORARY FAULT ALARMS. THE FAMILY THOUGHT THESE THINGS WERE CAUSED BY IMPENDING FREEDOM DRIVER FAILURE, SO THEY CHANGED FROM THE FREEDOM DRIVE. BACK TO NORMAL. VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR RECOMMENDED THE PATIENT COME TO EMERGENCY DEPARTMENT FOR ADMIT. VAD TEAM WILL MEET HIM. KEEP TOTAL ARTIFICIAL HEART (TAH) WITHIN SET PARAMETERS SET SPECIFIC FOR THE PATIENT; MAINTAIN THERAPEUTIC COAGS; CT ANGIO SHOWED PULMONARY EMBOLUS. SYNCARDIA CONSULTED REGARDING INTERNATIONAL EXPERIENCE OF TREATMENT OF PULMONARY EMBOLISM IN TAH PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887630 SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART SYSTEM ARTIFICIAL HEART LOZ SYNCARDIA SYSTEMS, LLC 500101

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening| R CARDIAC DRUGS| CVVHD (DIALYSIS)| DIALYSIS