inforMED
InjuryPCC

CEFALY DUAL

Received Mar 9, 2021 · Event occurred Dec 9, 2020

Report MW5099890 · MDR key 11453430

Device

Generic name

Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

Manufacturer

Cefaly Technology

Product problems

  • Wireless Communication Problem

Patient

52 YR

  • Blurred Vision
  • Blurred Vision

Narrative

Description of Event or Problem

I USE A CEFALY DUAL MIGRAINE DEVICE FOR MIGRAINES AND I THINK IT PICKS UP WIFI (OR SIMILAR SIGNALS) AND DAMAGES THE EYES AS ONE OF MY EYES KEPT GETTING BLURRY VISION WHICH THEN CLEARS UP IN A DAY OR TWO. I THEN CANCELLED WIFI AND WENT BACK TO ETHERNET AND THE PROBLEM HAS NOT REPEATED. I'M A LONG-TIME CEFALY USER SINCE AROUND 2015. I HAD THE FIRST VERSION WHICH IS LIKE A CROWN ON THE FOREHEAD AND THEN GOT THE SMALLER VERSION WHEN IT CAME OUT. IN SUM, I SUPPORT CEFALY AND CAN'T GO WITHOUT USING IT, BUT I NOW RATION THE USAGE ON THE DUAL BY ONLY USING THE 20-MINUTE SETTING. THE ORIGINAL CROWN VERSION WAS LIMITED TO 20 MINUTES AT A TIME. WHEN CEFALY WENT TO A 60-MINUTE SETTING ON THEIR CURRENT VERSIONS, I THINK THIS MADE IT DANGEROUS. OVERALL, I THINK THE FDA SHOULD REALLY INVESTIGATE THESE (HEAD OR BRAIN-MOUNTED) WIRELESS-TYPE BATTERY-POWERED DEVICES THAT EMIT SOUND WAVES AS THEY SEEM TO BE CAPABLE OF PICKING UP EXTRANEOUS SIGNALS. I'M NOT KIDDING - I HAVE USED THE CEFALY FOR 7 YEARS NOW ALMOST DAILY AND I HAVE EXTENSIVE KNOWLEDGE OF HOW IT WORKS AND THE RESULTS. I ALSO HAVE THE REAR ARNOLD STRAP AND THAT WORKS PRETTY WELL ALSO. PLEASE LOOK INTO IT. THANK YOU FOR LISTENING TO MY STORY. FDA SAFETY REPORT ID # (B)(4).