CEFALY

Description of Event or Problem

I PURCHASED A CEPHALY MEDICAL DEVICE PRESCRIBED BY MY NEUROLOGIST TO HELP DECREASE THE FREQUENCY OF THE HEADACHES, WHICH I HAVE SUFFERED WITH FOR MANY YEARS. I TESTED THE DEVICE FOR THE FIRST TIME ON A DAY THAT I WAS COMPLETELY WELL. I APPLIED THE DEVICE EXACTLY AS DESCRIBED IN THE MANUFACTURER'S INSTRUCTIONS. I LIMITED THE INTENSITY OF THE POWER TO THE LOWEST SETTING FOR THIS FIRST TRIAL. DESPITE THIS LOWEST SETTING, I HAD TO STOP THE DEVICE AND ABORT THE SESSION AT APPROXIMATELY 17 MINUTES OF USAGE RATHER THAN COMPLETE THE RECOMMENDED 20 MINUTES. SEVERAL MINUTES AFTER STARTING THE DEVICE, I BEGAN TO EXPERIENCE WEAKNESS IN MY JAW MUSCLES AND MY UPPER EXTREMITIES (PROXIMALLY MORE THAN DISTALLY) AND TO A LESSER EXTENT, MY PROXIMAL LOWER EXTREMITY MUSCLES. I ALSO DEVELOPED SIGNIFICANT DIZZINESS. THESE SYMPTOMS INCREASED UNTIL I DISCONTINUED THE USE OF THE DEVICE. AFTER SHUTTING THE CEFALY OFF, THE MUSCLE WEAKNESS AND DIZZINESS DID NOT IMMEDIATELY STOP. IT TOOK A PERIOD OF APPROXIMATELY 2 HOURS FOR COMPLETE RESOLUTION OF THESE SYMPTOMS. AS A PHYSICIAN, I FELT COMPELLED TO MAKE THIS REPORT, SINCE IN MY RESEARCH INTO THIS PRODUCT, I DID NOT SEE ANY SIMILAR COMPLAINTS, AND IN THE MANUFACTURER'S WARNINGS REGARDING ADVERSE REACTIONS, I NOTED REPORTS OF SLEEPINESS AND HEADACHE WITH USE, BUT NO OTHER NEUROLOGIC SYMPTOMS. CEFALY U.S. PATENT # 8, 428, 734.