BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCARDIA SYSTEMS, LLC

    MDR report key: 20348998 · Received October 1, 2024

    Report

    Report Number
    3003761017-2024-00116
    Event Type
    Death
    Date Received
    October 1, 2024
    Date of Event
    September 25, 2024
    Report Date
    October 1, 2024
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT DEATH DUE TO MULTI-SYSTEM ORGAN FAILURE. DEVICE CONFIRMED BY HOSPITAL STAFF TO NOT HAVE CAUSED OR CONTRIBUTED TO PATIENT DEATH. DEVICE WAS NOT EXPLANTED AND NO AUTOPSY WAS PERFORMED. SYNCARDIA HAS COMPLETED ITS EVALUATION AND IS CLOSING THIS FILE. IF NEW OR ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, SYNCARDIA WILL FILE A FOLLOW-UP MDR.

    Description of Event or Problem · 0

    REPORTED PATIENT DEATH FROM MULTI-SYSTEM ORGAN FAILURE AFTER 3 DAYS ON SUPPORT. THE DEVICE WAS NOT EXPLANTED AND NO AUTOPSY WAS PERFORMED AT PATIENT AND FAMILY REQUEST. PER HOSPITAL REPORT, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948415 SYNCARDIA SYSTEMS, LLC BIVENTRICULAR REPLACEMENT DEVICE LOZ SYNCARDIA SYSTEMS, LLC 130337

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Death