MAUDE Adverse Event Report: CEFALY TECHNOLOGY CEFALY ANTI-MIGRAINE DEVICE; NERVE STIMULATOR FOR MIGRAINES

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2015

Event Type  Injury  

Event Description

Upon utilization of cefaly device for migraines, patient states that tinnitus ensued and has continued 1 year post use.Patient also indicated that the character of her tinnitus (noise) currently experienced post use is the same as the character (noise) heard during use of the device.In (b)(6) 2015, patient contacted the manufacturer and was ignored.She states that they were unwilling to discuss unlisted side effects for this device.Patient states that there is no cure for her injury and her major concern is that side effects for this device is not accurately listed to inform the consumer.

• Brand Name: CEFALY ANTI-MIGRAINE DEVICE
• Type of Device: NERVE STIMULATOR FOR MIGRAINES
• Manufacturer (Section D): CEFALY TECHNOLOGY
• MDR Report Key: 5973026
• MDR Text Key: 55608443
• Report Number: MW5064984
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2015

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 52