MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 SENSOR 3.0; BRAEMAR TELEMETRY PATCH SYSTEM

Model Number	02-01846
Medical Device Problem Code	Failure to Transmit Record (1521)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The events transmitted during the patient study were reviewed by medical affairs.The patient had 1 pause trigger on (b)(6) 2022 at 2250 est.This event was reviewed by a cardiac technician and /determined to be sinus rhythm (sr).The patient had another pause trigger on (b)(6) 2022 at 2136 est.This event was also reviewed by a cardiac technician and determined to be sr.This study was force-deactivated on (b)(6) 2022.During the patient's second prescription, the patient had patient initiated event (pie) trigger for fainted on (b)(6) 2022 at 1838 est.The event was received, reviewed by a cardiac technician, and determined to be sinus rhythm.The patient was contacted to confirm the faint event; the cardiac technician spoke to patient, patient reports she did not faint, and no further notification efforts were warranted.There were pause triggers received on (b)(6) 2022.All events were reviewed by a cardiac technician and determined to be sinus rhythm.There were 2 pie triggers on (b)(6) 2022 for symptom skipped beat; skipped beat; both pies were reviewed by a cardiac technician and determined to be sr with isolated rare pvcs.There was 1 pie trigger (no symptoms recorded) on (b)(6) 2022; this was reviewed by a cardiac technician and determined to be sr.There was 1 pause/asystole trigger on (b)(6) 2022; this was reviewed by cardiac technician and determined to be sr.Medical affairs confirms the interpretation of the events.Based on the currently available clinical information, the events received for technician review were appropriately triaged and interpreted.
Event or Problem Description
It was reported that on (b)(6) 2022 that the patient experienced a syncope event while at work while wearing the mcot sensor - 3.0.The following morning the patient had another event while still wearing the device and passed out while driving their car.The patient reported to the emergency department (ed) and when the mcot sensor - 3.0 was interrogated it was reported that no events showed up on the monitor.On an unknown date after the patient reported to the hospital after passing out, however this time the patient was not wearing the mcot sensor it was decided the patient was to go back on 30-day mcot prescription.After about 3 weeks on service the patient had another syncope event, and the patient was called to report that they had a 17 second pause and needed to go the ed.The patient was admitted to the hospital and later had a pacemaker implanted.The patient believes that the due to the first mcot sensor not working properly they did not receive proper care and therefore, has a delay in treatment.
Additional Manufacturer Narrative
It was reported that the patient experienced a syncope event while at work while wearing the mcot sensor - 3.0.The mcot sensor - 3.0 was not returned for device evaluation.Evaluation was completed by the medical office and found that system worked as intended so there isn't a need for technical investigation.

• Brand Name: C6 SENSOR 3.0
• Common Device Name: BRAEMAR TELEMETRY PATCH SYSTEM
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121
• MDR Report Key: 21392820
• Report Number: 2133409-2025-00003
• Device Sequence Number: 20963880
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: +B146C6E10
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02-01846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female