CEFALY

Additional Manufacturer Narrative

DUE TO TECHNICAL DIFFICULTIES ENCOUNTERED WHILE SETTING UP THE ESG NEXTGEN SYSTEM, THIS SUBMISSION WAS DELAYED BY ONE DAY. THE INVESTIGATION WAS CONDUCTED BASED ON VERY LIMITED INFORMATION. KEY DETAILS, INCLUDING USER IDENTIFICATION AND DEVICE SPECIFIC INFORMATION SUCH AS MODEL AND SERIAL NUMBERS, WERE NOT PROVIDED, AND THE DEVICE IN QUESTION WAS NOT MADE AVAILABLE FOR EVALUATION. AS A RESULT, A THOROUGH ASSESSMENT OF THE INCIDENT COULD NOT BE COMPLETED. THE MANUFACTURER REVIEWED THE RELEVANT PRODUCTION RECORDS AND CONFIRMED THAT NO ANOMALIES OR ISSUES WERE IDENTIFIED. THERE IS NO CLEAR EVIDENCE INDICATING THAT THIS CASE MEETS THE CRITERIA FOR A REPORTABLE MEDICAL DEVICE REPORT MDR. HOWEVER, THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. WITH REGARD TO THE PATIENT STATEMENT DESCRIBING DISCOMFORT, IT IS NOTED THAT EACH USER HAS A DIFFERENT PAIN THRESHOLD TO STIMULATION. THE SENSATIONS EXPERIENCED WHILE USING THE CEFALY ARE NOVEL TO MOST USERS AND MAY REQUIRE AN ADJUSTMENT PERIOD. THE STIMULATION INTENSITY MAY BE SLIGHTLY UNCOMFORTABLE BUT SHOULD NOT BE PAINFUL. USERS ARE INSTRUCTED TO STABILIZE THE DEVICE AT A LEVEL JUST BELOW PAINFUL SENSATIONS UNTIL THE SKIN AND NERVES BECOME ACCUSTOMED TO THE STIMULATION INTENSITY. THESE INSTRUCTIONS ARE CLEARLY PROVIDED IN THE INSTRUCTIONS FOR USE IFU. DURING THE FIRST 14 MINUTES OF TREATMENT, THE STIMULATION INTENSITY INCREASES AUTOMATICALLY AND GRADUALLY. THE USER HAS THE OPTION TO STABILIZE THE INTENSITY AT ANY POINT DURING THIS PERIOD BY PRESSING THE DEVICE BUTTON ONCE. THE DEVICE WILL THEN MAINTAIN THE TREATMENT INTENSITY AT THE LEVEL SET WHEN THE BUTTON WAS PRESSED. IF THE USER WISHES TO REDUCE THE INTENSITY AFTER STABILIZATION, THE SESSION CAN BE TERMINATED BY REMOVING THE DEVICE FROM THE ELECTRODE PLACED ON THE FOREHEAD. THE SESSION WILL STOP AUTOMATICALLY UPON REMOVAL. THE USER MAY THEN RESTART THE TREATMENT AND STABILIZE THE INTENSITY AT A LOWER AND MORE COMFORTABLE LEVEL. THESE PROCEDURES ARE CLEARLY OUTLINED IN THE IFU. THE SECTION STABILIZING INTENSITY DURING THE FIRST 14 MINUTES EXPLAINS HOW TO MANAGE AND STABILIZE STIMULATION INTENSITY, WHILE THE SECTION STOPPING YOUR SESSION EARLY PROVIDES GUIDANCE ON HOW TO SAFELY TERMINATE A TREATMENT SESSION AT ANY TIME. THE IFU STATES THAT IF THE USER NEEDS TO STOP THE TREATMENT SESSION AT ANY POINT, SIMPLY REMOVING THE CEFALY ENHANCED OR CEFALY CONNECTED FROM THE ELECTRODE WILL END THE SESSION. THIS DEMONSTRATES THAT THE DEVICE IS DESIGNED TO PROVIDE USERS WITH FULL CONTROL OVER THEIR TREATMENT SESSIONS, INCLUDING THE ABILITY TO STOP TREATMENT AT ANY TIME, THEREBY SUPPORTING BOTH SAFETY AND EASE OF USE.

Description of Event or Problem

MANUFACTURER RECEIVED A NOTIFICATION FROM THE FDA ON 29 DECEMBER 2025 REPORTING THAT A PATIENT HAD PREVIOUSLY USED THE CEFALY DEVICE ONCE, EXPERIENCED DISCOMFORT DUE TO PERCEIVED HIGH INTENSITY AND UNABLE TO ADJUST THE INTENSITY TO A LOWER LEVEL. NO ADDITIONAL INFORMATION IS AVAILABLE TO THE MANUFACTURER. THERE IS NO EVIDENCE THAT THE DEVICE MALFUNCTIONED OR THAT THIS CASE MEETS THE CRITERIA FOR REPORTABLE EVENTS. THIS REPORT IS SUBMITTED SOLELY ON A PRECAUTIONARY PRINCIPLE.