Description of Event or Problem · 1
CAUSED LARYNX SPASMS; FILED UNDER: FOOD & DRUG ADMINISTRATION (FDA), NEUROMODULATION/ NEUROSTIMULATION, NEWS WELL, PRE-MARKET APPROVAL (PMA), REGULATORY/ COMPLIANCE TAGGED WITH: INSPIRE MEDICAL SYSTEMS INC., (B)(4), SLEEP MONITORING/ SLEEP APNEA. I HAVE THE "INSPIRE II: 3024, SERIAL NUMBER (B)(4) THAT WAS IMPLANTED ON (B)(6) 2017 FOR SLEEP APNEA AS AN UPPER AIRWAY STIMULATOR. ON TWO OCCASIONS I BELIEVE IT IS NO COINCIDENCE THAT THE INSPIRE DEVICE TURNED OFF NEGATIVELY IMPACTED THE APPLICATION OF ANESTHESIA DURING SURGERY. MY UNDERSTANDING IS THAT A TUBE IS USED DOWN THE THROAT DURING SURGERY TO APPLY THE ANESTHESIA. ON (B)(6) 2019 I HAVE A COLONOSCOPY AND AN UPPER GI ENDOSCOPY THAT THE DOCTOR REPORTED PROBLEMS WITH MY THROAT HAVING SPASMS BUT BECAUSE IT WAS A VERY SHORT PROCEDURE THEY CONTINUED. TODAY, (B)(6) 2020, I WAS TO HAVE RIGHT KNEE REPLACEMENT AND THE SAME ISSUE OCCURRED. THE DOCTOR SAID I HAVE BOTH BRONCHO AND LARYNX SPASM AND THEY ABORTED SURGERY AND I HAD FLUID IN MY LUNGS AS A RESULT. THE INSPIRE DEVICE MOVES THE TONGUE FORWARD AWAY FROM THE THROAT DURING SLEEP TO IMPROVE SLEEP. THERE ARE WIRES FROM THE DEVICE IMPLANTED IN THE CHEST TO THE NERVES NEAR THE TONGUE AS WELL AS WIRES TO THE LUNG WHEN I STOP BREATHING AT NIGHT. THOUGH THE DEVICE IS OFF, I AM CONCERNED THAT IT COULD IMPACT MY THROAT TO CAUSE SPASMS WHICH MAKE IT IMPOSSIBLE TO HAVE ANESTHESIA DURING SURGERY. I AM WRITING TO YOU IN HOPES YOU WILL LOOK INTO TO IT TO HAVE THEM FIX THE PROBLEM. FDA SAFETY REPORT ID # (B)(4).