Description of Event or Problem · 0
ON (B)(6) 2025, THE PATIENT WAS PARTICIPATING IN A SLEEP STUDY AND THE FIELD CLINICAL ENGINEER NOTICED THE PATIENT WAS RECEIVING INTERMITTENT STIMULATION THAT WAS INITIALLY ATTRIBUTED TO AN ACTIVATION CHIP MALFUNCTION. TROUBLE SHOOTING WAS PERFORMED AND THE ACTIVATION CHIP WAS RULED OUT AS CONTRIBUTING TO THE INTERMITENT STIMULATION. OTHER EXTERNAL COMPONENTS WERE ALSO DETERMINED TO NOT BE CONTRIBUTING TO THE PATIENT EXPERIENCE. ON (B)(6) 2025 THE PATIENT PRESENTED FOR A TITRATION VISIT WITH THE FIELD CLINICAL ENGINEER WHO NOTED THERE WAS NO STIMULATION DURING THE TITRATION. THE ATTENDING PHYSICIAN WAS CONTACTED AND X-RAYS WERE TAKEN AT A LATER DATE. (B)(6) 2025 THERE WAS A DECISION TO REPLACE THE IMPLANTABLE STIMULATOR. ON (B)(6) 2026 THE IMPLANTABLE STIMULATOR WAS SUCCESSFULLY REPLACED. IT WAS NOTED DURING THE SURGICAL PROCEDURE THAT THE IMPLANTABLE STIMULATOR PADDLES WERE SURROUNDED BY FIBROTIC TISSUE, THE ORIGINAL SUTURES WERE IN PLACE, AND THE DEVICE DID NOT MIGRATE. TESTING OF THE ORIGINAL DEVICE PRIOR TO REPLACEMENT AND THERE WAS STILL NO RESPONSE OR SUCCESSFUL DELIVERY OF STIMULATION. THE REPLACEMENT IMPLANTABLE STIMULATOR WAS TESTED PRIOR TO SKIN CLOSURE AND WAS FUNCTIONING AS EXPECTED. IT IS IMPORTANT TO NOTE THIS DEVICE IS NOT DISTRIBUTED IN THE US.