Description of Event or Problem · 0
I HAVE HAD ADVERSE EVENTS WITH THE INSPIRE MODEL 3028 DEVICE AND WANT TO REPORT THEM. ON (B)(6) 2025, I HAD THE INSPIRE MODEL 3028 IMPLANTED TO HELP ME GET A BETTER NIGHT'S SLEEP TO HELP MAINTAIN MY OVERALL HEALTH. IT WAS ACTIVATED ON (B)(6) 2025 AND HAS CONSISTENTLY NOT WORKED TO ACHIEVE THIS OUTCOME. I HAD ISSUES WITH THE FIRST REMOTE CONTROL THAT I WAS GIVEN, BEGINNING ON (B)(6) 25 WHEN IT WOKE ME UP AT 1:00 AM CAUSING ME DIFFICULTY IN BREATHING AND TALKING. I HAD TO CALL THE INSPIRE HELP LINE AND TRY MULTIPLE STEPS TO GET IT TO TURN OFF. FROM THAT DATE ON IT WOULD RANDOMLY TURN OFF AND ON. IT WAS REPLACED ON (B)(6) 2025, BUT THE NEW REMOTE HAD ISSUES WITH TURNING ON BY ITSELF AND ALSO TAKING MULTIPLE TIMES TO ENGAGE WITH THE IMPLANTED DEVICE. ADDITIONALLY, I BELIEVE THE DEVICE WAS IMPLANTED IN THE WRONG PLACE TOO CLOSE TO MY ARMPIT, WHICH CAUSES ME CONSIDERABLE PAIN AND DISCOMFORT. I CALLED INSPIRE TO STATE THIS AND I ALSO TOLD THIS TO THE DOCTOR AT EVERY VISIT. INSPIRE SAID THERE IS A WIDE RANGE FOR PLACEMENT AND THE DOCTOR KEPT SAYING THAT REGARDLESS, IT WAS WORKING. WHETHER THE DEVICE WAS PLACED IMPROPERLY, THE DEVICE IS NOT WORKING PROPERLY AND/OR THE DOCTOR AND INSPIRE REP ARE NOT PROPERLY ADDRESSING MY CONCERNS, I HAVE EXPERIENCED A NUMBER OF SIDE EFFECTS AND HEALTH ISSUES AS A RESULT. THESE INCLUDE RIGHT ARM PAIN THAT RADIATES INTO MY ARM PIT, CAUSING ITCHING AND TINGLING DOWN MY ARM. THE PAIN ALSO TRAVELS TO MY CLAVICLE AND NECK. THIS HAS RESULTED IN TOOTH, JAW, CHEEK, EYE AND EAR PAIN. I NOW SUFFER FROM RIGHT SIDE HEADACHES. MY THROAT OFTEN FEELS TIGHT, DRY AND SORE, AND I HAVE A RASPY VOICE. WHEN I TOLD THE DOCTOR ABOUT MY THROAT AND EAR PAIN, HE ADJUSTED THE DEVICE SETTINGS, BUT THE ADVERSE EFFECTS PERSIST. TO ADDRESS THESE VARIOUS SIDE EFFECTS, I INDEPENDENTLY TOOK IT UPON MYSELF TO SEE A DERMATOLOGIST, ORTHOPEDIST, DENTIST, OPTOMETRIST AND RETINA SPECIALIST. I FOLLOWED THROUGH WITH X-RAYS, IMAGING AND BLOOD WORK. ON (B)(6) 2026 I HAD A SLEEP STUDY THAT SHOWED I STILL HAVE SLEEP APNEA. ON (B)(6) 2026 I DISCUSSED THESE SLEEP STUDY RESULTS WITH THE DOCTOR. HE TOLD HE WOULD CONTACT THE INSPIRE REP AND THEN CALL ME TO HAVE ME BACK INTO THE OFFICE WITHIN TWO WEEKS FOR A PROCEDURE WITH THE REP PRESENT TO DISCUSS MOVING THE PLACEMENT OF THE DEVICE. NO CALL HAS COME. ON (B)(6) 2026 I CALLED THE INSPIRE HELP LINE TO REPORT THAT I HAD NOT HEARD BACK FROM THE DOCTOR'S OFFICE, AND ALSO THAT I CONTINUE TO HAVE PROBLEMS WITH THE REMOTE TURNING ON AGAIN BY ITSELF AFTER I HAVE TURNED IT OFF. I HAD BEEN WARNED THAT BEING AWAKE OR TAKING MEDICATION OR EATING WHEN THE DEVICE IS ON COULD CAUSE PERMANENT NERVE DAMAGE, SO THIS IS VERY CONCERNING TO ME. I WAS TOLD BY INSPIRE THAT I WOULD HEAR BACK ABOUT THIS NEXT WEEK. NO ONE HAS CONTACTED ME. AFTER ENDURING ALL OF THIS, I PLAN TO HAVE THE INSPIRE DEVICE REMOVED PERMANENTLY BY A DIFFERENT SURGEON BEFORE MY HEALTH SUFFERS AND FURTHER. THE SLEEP STUDY WAS CONDUCTED INDEPENDENTLY AT DEBORAH HOSPITAL IN BROWN MILLS, NEW JERSEY. HECC: 4875, 1816, 2195, 2330, 1924, 1994, 1880, 2396, 4487, 4906. DPC: 1557, 2939, 4086, 2577, 1524, 2616. REF: MW5186626.