BEUDAMED
    FDA Adverse Event Death Summary report: N

    C6 SENSOR 3.0

    MDR report key: 23544719 · Received November 13, 2025

    Report

    Report Number
    2133409-2025-00153
    Event Type
    Death
    Date Received
    November 13, 2025
    Report Date
    November 13, 2025
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    PMA / PMN Number
    K153473
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENTS TRANSMITTED ON (B)(6) 2025 (DATE OF LAST MSA ACTIVITY) WERE REVIEWED BY THE CLINICAL OPERATIONS AND MEDICAL SAFETY. PER MSA, POST-TAVR NOTIFICATION CRITERIA WERE ASSOCIATED WITH THE PATIENT STUDY. A REVIEW OF MSA ACTIVITY CONFIRMED 8 TRIGGERED EVENTS THAT MET CRITERIA FOR URGENT/ EMERGENT CRITERIA OCCURRED ON (B)(6) 2025 BETWEEN 0217 AND 0805 EST. THE NOTIFICATIONS INCLUDED: EMERGENT -ACCELERATED IDIOVENTRICULAR RHYTHM WITH TORSADES DE POINTES, EMERGENT -JUNCTIONAL RHYTHM WITH PAC(S) AND TORSADES DE POINTES, EMERGENT -TORSADES DE POINTES WITH MULTIPLE PAUSES NOTED, LONGEST PAUSE IS 8.6SECONDS, EMERGENT -VENTRICULAR FIBRILLATION WITH 9.4 SECOND PAUSE, VENTRICULAR FIBRILLATION WITH MULTIPLE PAUSES NOTED, LONGEST PAUSE IS 3.6SECONDS, URGENT - VENTRICULAR FIBRILLATION WITH MULTIPLE PAUSES NOTED, LONGEST PAUSE IS 3.6SECONDS, EMERGENT -VENTRICULAR FIBRILLATION WITH 1ST DEGREE AVB IVCD AND MULTIPLE PAUSES NOTED, LONGEST PAUSE IS 3.6 SECOND, EMERGENT -VENTRICULAR FIBRILLATION WITH MULTIPLE PAUSES NOTED, LONGEST PAUSE IS 8.1 SECONDS, AND URGENT - ATRIAL FLUTTER WITH IVCD SINUS BEATS AND MULTIPLE PAUSES NOTED, LONGEST PAUSE IS 3.6 SECONDS. THE EVENTS WERE TRANSMITTED TO MSA ON (B)(6) 2025 0911 - 0947 EST AND THEN ADJUDICATED AND NOTIFIED PER SOP ON (B)(6) 2025. DATE OF DEATH AND TIME OF DEATH IS CURRENTLY NOT CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THERE WAS A DELAY IN TRANSMISSION OF CARDIAC EVENTS MEETING URGENT/ EMERGENT NOTIFICATION CRITERIA. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE IMPACT OF THE DELAY. THE CAUSE OF THE DELAYED TRANSMISSION CANNOT BE DETERMINED BY CLINICAL REVIEW.

    Description of Event or Problem · 0

    AFTER REVIEWING THE PATIENT'S FILE, IT WAS NOTED THAT THE PATIENT BEGAN SERVICE ON (B)(6) 2025 WITH THE MCOT SERVICE - UNSPECIFIED SUBSYSTEM / SUBCOMPONENT AND WAS SCHEDULED TO END SERVICE ON (B)(6) 2025. MSA ACTIVITY STARTED ON (B)(6) 2025. ON (B)(6) 2025 WITHIN THE MSA ACTIVITY LOG, THERE WERE MULTIPLE EMERGENT AND URGENT ESCALATION NOTIFICATIONS DOCUMENTED. IT WAS NOTED ON (B)(6) 2025 THE MEDICAL CENTER RECEIVED MULTIPLE EMERGENT EVENTS FOR THIS PATIENT THAT WERE RECEIVED LATE FROM THE MONITOR. MEDICAL CENTER NURSE EXPRESSED CONCERN THAT THESE EVENTS WERE OVER 30 HOURS LATE. TECHNICIAN EXPLAINED THAT WE RECEIVED THEM TODAY FROM THE MONITOR AND WE DO NOT HAVE INSIGHT ON WHY THIS OCCURRED, WANTED TO GIVE A HEADS UP ON THIS ISSUE AS THE EVENTS WERE SEVERE. EVENT TIMES RANGE FROM (B)(6) 2025 (2:17) EDT TO 6:57 EDT. THE EVENTS STARTED COMING ON (B)(6) 2025 (9:11) EDT. FIRST CALL TO PRACTICE (B)(6) 2025 AT (10:09) EDT, NO ONE AVAILABLE TO TAKE CALL PER SERVICE REPRESENTATIVE WHO STATED "WILL SEND A MESSAGE TO CALL US BACK. SECOND CALL (11:32) EDT WAS TOLD SOMEONE WILL CALL US BACK, THIRD CALL (12:13) EDT LEFT MESSAGE WITH ADMINISTRATIVE ASSISTANT. IT WAS DOCUMENTED THAT THE PATIENT DIED ON (B)(6) 2025. THE PRACTICE COMPLAINED ABOUT DELAYED TRANSMISSION TIME AND VERBAL NOTIFICATION. IT WAS NOTED THAT THE REASON WHY THE NOTIFICATION FROM(B)(6) 2025 WERE DELAYED IN VERBALLY NOTIFYING, IS BECAUSE THE DEVICE DID NOT TRANSMIT THE ECG (ELECTROCARDIOGRAM) DATA OVER TO US UNTIL (B)(6) 2025, APPROXIMATELY 30 HOURS LATER, HENCE THE DELAY IN VERBALLY NOTIFYING THE PRACTICE. WE DO NOT KNOW DEVICE WAS DELAYED IN TRANSMITTING OVER THE ECG STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2206613 C6 SENSOR 3.0 MCOT SENSOR - 3.0 DSI BRAEMAR MANUFACTURING, LLC 02-01846

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death MCOT MONITOR - A10E - VERIZON-UNLOCKED(B)(6).