MAUDE Adverse Event Report: FITBIT FITBIT SURGE

Model Number SURGE

Device Problem Insufficient Information (3190)

Patient Problem Atrial Flutter (1730)

Event Date 03/15/2015

Event Type  Injury  

Event Description

After 20 days using my fitbit surge, a device that measures exercise activity including heart rate and gps location, i had an onset of atrial flutter, an electrical defect in the heart that caused by upper chambers to be firing at three times the rate of my lower heart.The fitbit measures heart rate emitting a green light to the inside wrist.There is also a blue tooth connection between the watch and an i phone.My doctor explained my condition as occurring when the electrical current going through my atrial area "slows a little" and the electrical pulse can be diverted to another path.This other path multiplies the number of beats being requested by the atrial muscles.The affect is that my heart beat on the number of beats being requested by the atrial muscles.The affect is that my heart beat on this slowing of the impulse can happen.Is it pure coincidence that the flutter started 20 days into my using the fitbit surge, or is there a connection of some sort? i am a (b)(6) year old male, which probably puts me on the higher end of age distribution for this product.I may have had the condition developing for some time, it apparently is an older person's issue.It took my doctor over six months to diagnose the atrial flutter.I have since had an atrial ablation to remove the circuitry causing the multiple beats.My heart is now in a sinus rhythm, and i am coming back to normal heart function.The flutter was easily detected by ekg, once an ekg was taken.However, without treatment atrial flutter can lead to a stroke or worse.As you may know the fitbit has a lot of data available, and i can show that if you like.The atrial flutter caused my heartrate to be understated in the fitbit algorithm, so i can point to (b)(6) as the onset of the condition, and i can show the activity for each day from late february to present.My concern is that with all of these electronics on my wrist, and a light penetrating to my blood stream to calculate bpm, did that somehow affect the speed of the signal leading to the atrial flutter? (b)(6).

• Brand Name: FITBIT SURGE
• Type of Device: FITBIT SURGE
• Manufacturer (Section D): FITBIT
• MDR Report Key: 5267579
• MDR Text Key: 32782118
• Report Number: MW5058307
• Device Sequence Number: 1
• Product Code: MNW
• 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: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SURGE
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 61 YR
• Patient Weight: 120