Description of Event or Problem · 0
ON (B)(6) 2025 IT WAS NOTED DURING A PATIENT CLINIC VISIT WHILE ATTEMPTING TO ADJUST PARAMETERS, THERE WAS LITTLE TO NO TONGUE PROTRUSION. IT WAS REPORTED ON 6 FEB 2026 THAT A REVISION SURGERY TOOK PLACE ON (B)(6) 2026. AFTER THE INITIAL INCISION, ACCESS TO THE GENIOGLOSSUS MUSCLE WAS ACHIEVED AFTER APPROXIMATELY 30 MINUTES. THE GENIOGLOSSUS WAS SURROUNDED BY FIBROTIC, PARTIALLY OSSIFIED (BONEY) TISSUE EXTENDING FROM THE HYOID BONE INTO THE GENIOGLOSSUS MUSCLE. CRANIALLY FROM THE HYOID, THE OSSIFICATION TERMINATED WITHIN THE GENIOGLOSSUS AND TRANSITIONED INTO MUSCULAR TISSUE. THE PADDLE ELECTRODES AS WELL AS THE HYPOGLOSSAL NERVE WERE SURROUNDED BY CAPSULAR TISSUE, WITH A DISTINCT LAYER FORMED BETWEEN THE PADDLE ELECTRODE AND THE NERVE. AN EXTERNAL STIMULATOR TEST WAS ATTEMPTED AND SHOWED NO TONGUE MOVEMENT AND NO NIM SIGNALS AT 100% OUTPUT. AFTER PLACEMENT OF A NEW IMPLANTABLE STIMULATOR IN THE SAME LOCATION, REPEAT EXTERNAL STIMULATOR TESTING AT 100% AND ACTIVATION CHIP/ DISPOSABLE PATCH TESTING RESULTED IN MINIMAL TONGUE TWITCHING AND MINIMAL NIM SIGNAL. THE HYPOGLOSSAL NERVE COULD NOT BE ADEQUATELY VISUALIZED DUE TO COMPLETE ENCAPSULATION. SEPARATION OF THE CAPSULAR TISSUE FROM THE NERVE WAS CONSIDERED TOO HIGH RISK BY THE TREATING PHYSICIAN WHICH COULD POTENTIALLY LEAD TO HYPOGLOSSAL NERVE PALSY. THE NEWLY PLACED IS WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED WITHOUT IMPLANTATION OF A NEW IMPLANTABLE STIMULATOR. IT IS IMPORTANT TO NOTE THE IMPLANTABLE DEVICE IN THIS REPORT IS NOT DISTRIBUTED IN THE UNITED STATES.