MAUDE Adverse Event Report: CEFALY TECHNOLOGY CEFALY DEVICE; STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Visual Impairment (2138); Confusion/ Disorientation (2553); Unspecified Ear or Labyrinth Problem (4474)

Event Date 05/30/2021

Event Type  Injury  

Event Description

I have suffered from episodic migraines for the last 20 years.Most of my migraines start directly above my right eyebrow, a branch of the trigeminal nerve.Upon learning about the fda approved without a prescription cefaly device (a trigeminal nerve stimulator), i decided to give it a test since there was a 60-day trial.I purchased the product on (b)(6) and i used the product between 8 and 10 times both in the acute and preventative settings over the course of the next 30 days.I started to notice i was experiencing fluctuating bilateral ear fullness that would last a few hours a day but chalked that up to seasonal allergies.The ear fullness continued to get worse over time at which point i stopped using the cefaly as regularly in the first 2 weeks after receiving the device.I only used it 2 times after (b)(6), a 60-minute session on (b)(6) and a 20-minute session on (b)(6).By the (b)(6), i started to notice severe brain fog, vision sensitivity and worsening constant ear fullness that never went away.Cefaly's medical team claimed i may have placed the device too close to the eyebrows despite what their instructional videos show which might result in higher stimulation to a dense concentration of nerves as they exit the head.Nowhere was it explained in the video or packet that placing the device 1/4 of an inch too low could result in permanent damage.Now, 2 months later, (b)(6) in medical bills, a brain mri and ct and numerous doctors visits, i am still dealing with these problems.The fda should pull the cefaly off the market and definitely not make it available without a prescription until more extensive research has been done.Fda safety report id # (b)(4).

• Brand Name: CEFALY DEVICE
• Type of Device: STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE
• Manufacturer (Section D): CEFALY TECHNOLOGY
• MDR Report Key: 12238890
• MDR Text Key: 264093537
• Report Number: MW5102802
• Device Sequence Number: 1
• Product Code: PCC
• 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: 07/24/2021

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 33 YR
• Patient Weight: 70