Description of Event or Problem · 0
THE AFFECTED PATIENT IS A 22-YEAR-OLD FEMALE WITH A HISTORY OF CHRONIC TRAUMATIC TETRAPLEGIA, AND BLE PARALYSIS AFTER FALL ON SNOW ON (B)(6) 2025. SHE BEGAN UNDERGOING SPINAL STIMULATION IN (B)(6) 2026 UTILIZING THE ARC-EX SYSTEM TO ADDRESS BILATERAL HAND FUNCTION AND ALLOW FOR MORE INDEPENDENCE WITH ADLS. ON (B)(6) 2026, THE PATIENT PRESENTED FOR HER APPOINTMENT, WHICH INCLUDED APPLICATION OF ELECTRODES FOR USE WITH THE ARC-EX SYSTEM. A SKIN INSPECTION WAS PERFORMED PRIOR TO DONNING THE DEVICE AND ELECTRODES WERE PLACED AT C3 AND T1, AND BILATERAL ILIAC CRESTS. THE THERAPIST TITRATED THE AMPLITUDE UP TO 85 MA (FIRST 15 MINUTES) PER PATIENT TOLERANCE. AFTER FIRST 15 MINUTES, PT STATED THAT AREA UNDER C3 ELECTRODE FELT WARM. THE PT STOPPED THE STIMULATION AND PERFORMED A SKIN CHECK TO THAT AREA. THE AREA UNDER C3 HAD ERYTHEMA AND A CENTRAL RAISED WHITE AREA (3 MM DIAMETER). THE PT MODIFIED THE ELECTRODE PLACEMENT TO AVOID THE AREA OF IRRITATION AND RESUMED STIMULATION AT 35 MA AFTER A 5-MINUTE BREAK. TOTAL STIMULATION ON TIME APPROX. 35 MINUTES. AFTER DOFFING THE ARC-EX DEVICE AND ELECTRODES A SKIN ASSESSMENT WAS PERFORMED. ALL AREAS WERE INITIALLY ERYTHEMATOUS FOLLOWING ELECTRODE REMOVAL, AN EXPECTED AND TRANSIENT FINDING, WITH MODERATE RESOLUTION BY THE END OF THE SESSION, WITH THE EXCEPTION OF THE AREA PREVIOUSLY UNDERNEATH THE C3 ELECTRODE, WHERE THE SKIN ASSESSMENT REMAINED THE SAME - ERYTHEMA WITH A CENTRAL RAISED WHITE AREA (3 MM DIAMETER). APPROXIMATELY 90 MINUTES AFTER THE SESSION TERMINATED, ANOTHER SKIN CHECK WAS PERFORMED AND THE AFFECTED AREA IN THE CENTER HAD PROGRESSED TO A FLUID FILLED BLISTER. PT EDUCATED TO CONTINUE TO PERFORM SKIN CHECKS ON AREA OF IRRITATION OVER THE WEEKEND, COUNSELED ON FIRST AID. WILL MONITOR AT NEXT SESSION FOR ANY CHANGE. REPORT FILE WITH (B)(6) DEPT OF PUB HEALTH AS THIS MEETS OUR REPORTING REQUIREMENTS FOR A SERIOUS REPORTABLE EVENT.