Description of Event or Problem · 0
WHILE USING THE NUFACE TRINITY DEVICE ON THE MORNING OF (B)(6) 2022, I LOST CONSCIOUSNESS, WAKING ON THE FLOOR WITH MY SCALP BLEEDING. EXPERIENCED A SECOND EVENT OF LOSING CONSCIOUSNESS WHILE MY HUSBAND DROVE ME TO THE HOSPITAL, AND A THIRD AND FOURTH WHILE IN THE EMERGENCY DEPARTMENT TRIAGE. INITIAL SYSTOLIC BLOOD PRESSURE WAS IN THE 80'S IN TRIAGE. BEDSIDE MONITORS CAPTURED A FIFTH EVENT AND THE CARDIOLOGIST DOCUMENTED I SHOWED BRIEF PAROXYSMAL ATRIAL FIBRILLATION, ACCELERATED JUNCTIONAL RHYTHM, SINUS TACHYCARDIA, SINUS PAUSE, AND SINUS BRADYCARDIA AS LOW AS 28 BEATS PER MINUTE. INITIAL COMPREHENSIVE METABOLIC PANEL NOTED AN ABNORMAL THYROID-STIMULATING HORMONE (5.836) AND POTASSIUM (3.2) LEVELS. SCALP LACERATION WAS REPAIRED WITH 11 STAPLES. I WAS ADMITTED TO THE INTENSIVE CARE UNIT WITH AN EMERGENCY CONSULTATION WITH A CARDIOLOGIST THAT I MAY REQUIRE A TEMPORARY PACEMAKER/PERMANENT PACEMAKER. THAT AFTERNOON, MY DAUGHTER DISCOVERED I WAS USING THE NUFACE DEVICE DURING THE FIRST EVENT AND BRIEFED HOSPITAL STAFF ON THE DEVICE'S WARNING TO NOT APPLY STIMULATION ACROSS YOUR CHEST AS THE INTRODUCTION OF ELECTRICAL CURRENT IN TO THE CHEST MAY CAUSE RHYTHMIC DISTURBANCES TO YOUR HEART, WHICH COULD BE LETHAL. THE ELECTROPHYSIOLOGY CARDIOLOGIST DECIDED IT WOULD BE VERY REASONABLE TO HOLD ON A PERMANENT PACEMAKER GIVEN THE IMPROVEMENT AND POSSIBLE REVERSIBLE CAUSE RELATED TO THE ELECTRICAL CURRENT DEVICE I HAD BEEN USING. I WAS ADVISED TO STOP TAKING MY BLOOD PRESSURE MEDICATION AND WAS ORALLY ADMINISTERED POTASSIUM UNTIL ITS LEVEL REACHED 5.8. ECHOCARDIOGRAM SHOWED MY LEFT VENTRICLE IS NORMAL IN SIZE WITH NORMAL WALL THICKNESS AND SYSTOLIC FUNCTION.; RIGHT VENTRICLE IS NORMAL IN SIZE WITH NORMAL SYSTOLIC FUNCTION; NO SIGNIFICANT VALVULAR ABNORMALITIES; NO PERICARDIAL EFFUSION. SINCE MY RHYTHM REMAINED STABLE FOR ABOUT 24 HOURS, I WAS TRANSFERRED OUT OF THE INTENSIVE CARE UNIT TO A TELEMETRY BED THE AFTERNOON OF (B)(6) 2022. SINCE THERE WERE NO FURTHER ACUTE EVENTS WHILE IN TELEMETRY, I WAS DISCHARGED ON (B)(6) 2022 WEARING A ZIO AMBULATORY CARDIAC MONITOR AND INSTRUCTIONS TO RECORD MY BLOOD PRESSURE AT HOME FOR 2 WEEKS. SCHEDULED AN APPOINTMENT WITH MY PRIMARY PHYSICIAN FOR (B)(6) 2022 FOR BLOOD PRESSURE MANAGEMENT. SCHEDULED A HOSP F/U AND ZIO REPORT REVIEW APPOINTMENT WITH CARDIOLOGIST FOR (B)(6) 2022. STAPLES WERE REMOVED ON (B)(6) 2022. DEVICE USAGE BACKGROUND: USED THE NUFACE TRINITY DEVICE ON MY FACE 5 EVENINGS A WEEK ACROSS (B)(6) 2021, 3 EVENINGS A WEEK ACROSS (B)(6) 2021 THROUGH (B)(6) 2022, AND FINALLY 3 MORNINGS A WEEK ACROSS (B)(6) 2022. I DID NOT USE THE DEVICE ON MY NECK, NEAR MY THYROID GLAND, OR ACROSS MY CHEST. FELT LOW ENERGY AFTER USING THE DEVICE IN THE MORNING. FDA SAFETY REPORT ID# (B)(4).