MAUDE Adverse Event Report: CEFALY TECHNOLOGY CEFALY; CEFALY CONNECTED

Model Number 10810

Device Problems Use of Incorrect Control/Treatment Settings (1126); Use of Device Problem (1670)

Patient Problems Headache (1880); Nausea (1970); Balance Problems (4401)

Event Date 12/28/2023

Event Type  Injury  

Event Description

The information received in the report was obtained following a report by the patient (b)(6) 2023 and discussion with the patient regarding his symptoms and hospital course with the most recent discussion occurring (b)(6) 2024.Mr (b)(6) has a medical history of chronic migraines and obtained the cefaly device through his va medical providers.After receiving the cefaly device he experienced a "very bad migraine" and attempted therapy on acute treatment mode.During treatment (b)(6) 2023 he noted that the treatment intensity gradually increased beyond what was tolerable.Per the instruction manual he pressed the device button with intension to to plateau the stimulation however pressed the device button twice then repeating causing the opposite effect of ramping up the intensity.Eventually the stimulation became uncomfortable enough that he pulled off the device citing worsened headache, dizziness and severe nausea.He described the dizziness as tingling of the whole head as well as disequilibrium without vertiginous symptoms as if stepping off a boat.He mentions that prior to using cefaly he experienced symptoms of intermittent dizziness, whole head tingling and nausea with headaches but the symptoms after treatment were more severe and persistent.He was able to walk to bed and fall asleep.When he awakened to use the restroom during the night, he realized that he could not walk because of the severity of the dizziness.To be clear he could move his legs but he reported inability to coordinate his leg movements "as if i was on a boat" without directional pull or sway in symptoms.He also reported constant and severe headache with nausea which prevented him from taking foods or water by mouth.Though his symptoms gradually improved over several days, they continued to persist, especially nausea leading to poor po intake and loss of 10lbs.He required a walker where he was not using one prior to get around or he felt like he would fall.On (b)(6) 2024 and called 911 and was evaluated at (b)(6) hospital in (b)(6) and had work-up including mri brain, cervical spine, echo-cardiogram, cta of the head of neck.By report work-up demonstrated chronic cervical degenerative disk disease and mild cerebral atherosclerosis but otherwise testing was normal.He was in hospital for 4 days and evaluated by physical therapist and occupational therapist who said "there is nothing i can do for you".He has a outpatient neurologist who evaluated him and could not figure out what occurred.He was discharged home with persistent symptoms then was seen and readmitted to the (b)(6) va due to persistent severe nausea and imbalance/dizziness.Simular testing and evaluation was performed including mri/mra head and neck, echocardiogram, ekg, physical and occupational therapy with normal testing and results.He primarily had treatment for migraine.He was discharged home after 5 days with plan for outpatient physical and occupational therapy.Currently his nausea has resolved and dizziness has improved however he continues to have persistent imbalance requiring a walker and near constant headache.Because his symptoms were persistent, this submission was precautionary pending further information from the patient's status.

• Brand Name: CEFALY
• Type of Device: CEFALY CONNECTED
• Manufacturer (Section D): CEFALY TECHNOLOGY; rue louis plescia 34,; 4102 seraing; 4102 ; BE 4102
• MDR Report Key: 18769553
• MDR Text Key: 336183264
• Report Number: 3010760764-2024-00001
• Device Sequence Number: 1
• Product Code: PCC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2024

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 Model Number: 10810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2024
• Distributor Facility Aware Date: 01/25/2024
• Device Age: 5 MO
• Event Location: Home
• Date Report to Manufacturer: 02/23/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMLODIPINE (THERAPY START DATE UNKNOWN); ATORVASTATIN (THERAPY START DATE UNKNOWN); B12 (THERAPY START DATE UNKNOWN); BUPROPRION (THERAPY START DATE UNKNOWN); LISINOPRIL (THERAPY START DATE UNKNOWN); MAGNESIUM (THERAPY START DATE UNKNOWN); PLAVIX (THERAPY START DATE UNKNOWN); QULIPTA (THERAPY START DATE UNKNOWN); VATAMIN D (THERAPY START DATE UNKNOWN); VENLAFAXINE (THERAPY START DATE UNKNOWN)
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White