Description of Event or Problem · 0
I WAS IMPLANTED ON (B)(6) 2024 WITH INSPIRE HYPOGLOSSAL NERVE STIMULATOR FOR SLEEP APNEA. MODEL: 3028 IPG 900-007-017, SERIAL NUMBER: (B)(6). IT WAS ACTIVATED ON (B)(6). I HAVE USED IT NIGHTLY SINCE ACTIVATION AND IT HAS BEEN UNCOMFORTABLE BUT SEEMED TO WORK OK AT LOWER-LEVEL SETTINGS. I COULD NOT GET ABOVE 3 FOR VERY LONG BECAUSE IT WAS TOO STRONG AND KEPT ME AWAKE AT NIGHT. I TRIED LEVEL 4 BUT THAT WAS SHORT-LIVED DUE TO DISCOMFORT. I NOW HAVE IT ON LEVEL 2 AND TURNED IT DOWN TO LEVEL 1 BECAUSE OF DISCOMFORT AT NIGHT. I NOTICED ON (B)(6) AND TODAY (B)(6) THAT IT IS CAUSING STIMULATION EVEN THOUGH IT ISN'T TURNED ON. THE IMPLANT SEEMS TO STILL BE ACTIVE AND SENDS ELECTRICAL IMPULSES TO MY TONGUE, THROAT, AND EAR ON MY RIGHT SIDE. I CAN HEAR IT AND FEEL IT. I COULD NOT SLEEP AT ALL LAST NIGHT (B)(6) DUE TO THE DISCOMFORT. IT SEEMS TO BE SHORT CIRCUITING OR SOMETHING AND I AM CONCERNED ABOUT MY HEALTH DUE TO THIS DEVICE. I HAVE MY FIRST FOLLOW UP WITH MY SURGEON ON (B)(6) SINCE IT WAS ACTIVATED. I AM VERY CONCERNED DUE TO THE RECENT RECALLS OF OTHER INSPIRE IMPLANTS THIS PAST YEAR. I WANT TO BE SURE THAT THIS PARTICULAR MODEL IS ALSO INCLUDED IN THE RECALL AND NEED TO GET IT REMOVED OR REPLACED ALTHOUGH I AM HESITANT TO GET IT REPLACED CONSIDERING THE DIFFICULTIES I AM HAVING WITH THIS MEDICAL DEVICE.