[20118713]
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.
Patient Sequence No: 1, Text Type: D, B5