BEUDAMED
    FDA Adverse Event Death Summary report: N

    C6 SENSOR 3.0

    MDR report key: 19711657 · Received July 10, 2024

    Report

    Report Number
    2133409-2024-00039
    Event Type
    Death
    Date Received
    July 10, 2024
    Date of Event
    June 9, 2024
    Report Date
    November 8, 2024
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    UDI-DI
    B146C6E10
    PMA / PMN Number
    K081444
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT EXPIRED POST TAVR PROCEDURE. THE DEVICE WAS NOT RETURNED FOR DEVICE EVALUATION. EVALUATION WAS UNABLE TO BE PERFORMED AS THE DEVICE WAS NOT RETURNED OR IS UNABLE TO BE RECOVERED. ENGINEERING EVALUATION WAS UNABLE TO BE PERFORMED AS THE DEVICE WAS NOT RETURNED. HE SENSOR WAS SCRAPPED INTO MRB LOST. PT FAMILY STATED THAT THE DEVICE WAS LOST WHEN THE PARAMEDICS PICKED UP THE PATIENT. NO IMAGES HAVE BEEN PROVIDED BY THE PATIENT TO CORROBORATE THE ALLEGATION. THERE IS NO EVIDENCE THAT THE SENSOR CONTRIBUTED TO PATIENT EXPIRY.

    Description of Event or Problem · 0

    ON (B)(6) 2024 THE PATIENT BEGAN MCOT MONITORING. IT WAS REPORTED ON (B)(6) 2024 THAT ON (B)(6) 2024 THE PATIENT PASSED AWAY AND THE SENSOR WAS LOST BY EMS. THE EXACT CAUSE OF DEATH IS UNKNOWN. IT IS KNOWN THAT THE PATIENT'S HUSBAND FOUND HER, AND CPR WAS PERFORMED. EARLIER IN THE WEEK ON AN UNKNOWN DATE THE PATIENT HAD A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE AND SOMETIME POST TAVR PROCEDURE THE PATIENT EXPERIENCED HEARTBLOCK. IT IS UNKNOWN IF THE PATIENT HAD HISTORY OF HEARTBLOCK PRIOR TO THE TAVR PROCEDURE. OUTSIDE OF THE TAVR PROCEDURE THE PATIENT'S MEDICAL HISTORY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351879 C6 SENSOR 3.0 MCOT SENSOR - 3.0 DSI BRAEMAR MANUFACTURING, LLC 02-01846 B146C6E10

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Death