MAUDE Adverse Event Report: BARDY DIAGNOSTICS, INC. BARDY DIAGNOSTICS CARNATION AMBULATORY MONITOR (CAM); RECORDER, MAGNETIC TAPE, MEDICAL

Model Number B1000R1400

Device Problems Use of Device Problem (1670); Output Problem (3005)

Patient Problems Tachycardia (2095); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/11/2022

Event Type  Injury  

Event Description

(b)(6) 2022, a cardiologist put me on a 14 day bardy diagnostics cam heart monitor.Two days after wearing the monitor i experienced inappropriate sinus tachycardia (ist) with a resting heart rate of 141 beats per minute (bpm) that lasted for about 3 hours until i removed the monitor.My heart rate was monitored with a kardia mobile ekg, an omron blood pressure monitor and an oxygen/pulse rate monitor.My exercising heart rate has never been more than 110 bpm.I was not having any physical symptoms so i decided to try to determine the cause of the tachycardia instead of going to the emergency room.What i found is that with some people a heart monitor that uses 5g bluetooth communications, which operates at 2.4 ghz, can cause the heart's sinus node to lock on to a harmonic frequency of the 5g signal and produce a heart rate of between 140 to 150 bpm.With the data from my verification devices, i have proof of this happening to me and i informed bardy diagnostics of this event.Bardy diagnostics response to me was that the monitor that i was using did not utilize 5g bluetooth technology.However, their patent specifies that it contains both bluetooth and wi-fi capability, although it may not have been activated.I checked the cam monitor in a faraday cage and verified that it was not transmitting a bluetooth signal as bardy had said.This raised the question of why i experienced inappropriate sinus tachycardia while wearing their monitor.Somehow it had to be associated with the 5g bluetooth frequency of 2.4 ghz which can cause a pulse rate at a 5g harmonic frequency.The only explanation that i can determine, in my case, is that the length of the sensor wires on the bardy cam monitor is very close to a full wavelength for a 2.4 ghz rf signal, making it an excellent antenna that will pick up and amplify any 2.4 ghz signal in the area.I think this is what happened to me.While i was having the ist, i measured the amount of rf radiation that my body was receiving.The amount of rf radiation in the area was 4.5 mw/m2.When i put the meter close to the cam monitor it went to 171 mw/m2.Anything over 10 mw/m2 is considered dangerous.I am an 84 year old retired electronics engineer, in good health and have not experienced any ill effects from my experience, but long term i have no way of knowing.Depending on your findings and to hopefully prevent someone in poor health from having a bad experience, i would like to request that the fda inform the medical profession of the possibility that patients could have inappropriate sinus tachycardia (ist) when using the cam device.That alone would be a great service to humanity.

• Brand Name: BARDY DIAGNOSTICS CARNATION AMBULATORY MONITOR (CAM)
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• Manufacturer (Section D): BARDY DIAGNOSTICS, INC.
• MDR Report Key: 16753492
• MDR Text Key: 313535415
• Report Number: MW5116711
• Device Sequence Number: 1
• Product Code: DSH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/28/2023
• Device Model Number: B1000R1400
• Device Lot Number: 033815
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White