FITBIT SURGE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-10 for FITBIT SURGE manufactured by Fitbit.

Event Text Entries

[32782118] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5058307
• MDR Report Key: 5267579
• Date Received: 2015-11-10
• Date of Report: 2015-11-10
• Date of Event: 2015-03-15
• Date Added to Maude: 2015-12-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: FITBIT SURGE
• Generic Name: FITBIT SURGE
• Product Code: MNW
• Date Received: 2015-11-10
• Model Number: SURGE
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: FITBIT

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Deathisabilit	2015-11-10