MAUDE Adverse Event Report: CEFALY TECHNOLOGY CEFALY

Lot Number 65B45 14073 D4.23

Device Problem Insufficient Information (3190)

Patient Problems Weakness (2145); Dizziness (2194)

Event Date 08/01/2014

Event Type  Injury  

Event Description

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.

• Brand Name: CEFALY
• Type of Device: CEFALY
• Manufacturer (Section D): CEFALY TECHNOLOGY; herstal ; BE
• MDR Report Key: 4181806
• MDR Text Key: 20118713
• Report Number: MW5038595
• Device Sequence Number: 1
• Product Code: PCC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial

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?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 65B45 14073 D4.23
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2014
• Patient Sequence Number: 1