MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT PPM

Model Number 02-02045

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chest Pain (1776)

Event Type  Injury  

Event Description

The patient reported that the sensor was placed at their doctor's office ontop of her implanted defibrillator.Once they got home the patient started feeling pain on their chest, legs, stomach and started experiencing a headache.The patient removed the device instantly and was suggested to seek medical attention.The patient went to the emergency room (er) due to severe chest pains.The device is expected to be returned.

Manufacturer Narrative

It was reported the patient experienced pain after the mcot c6 sensor was placed ontop of their defibrillator.The device was returned for investigation.Device was inspected for general physical integrity and found the blue seal on the sensor damaged from customer pry marks.Engineering evaluation could not replicate the reported event.The sensor is unlikely to have caused or contributed to the reported patient symptoms.Per the ifu, "the ecg recorder is not intended for use on patients with implanted pacemakers." a definitive root cause could not be determined.

• Brand Name: C6 MCOT PPM
• Type of Device: C6 MCOT PPM
• 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: 17920944
• MDR Text Key: 325501656
• Report Number: 2133409-2023-00064
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 02-02045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female