Description of Event or Problem · 0
A REPORTER CALLED TO SUBMIT A REPORT ABOUT INSPIRE SLEEP APNEA DEVICE THAT WAS IMPLANTED IN HIM IN 2023. HE SAID IN THE BEGINNING THE DEVICE WORKED AS INTENDED. HOWEVER, ABOUT 3 MONTHS LATER THE DEVICE ACTIVATED AND WOULD NOT STOP WITH THE CONTROLLING MOUSE. IN THE PROCESS HIS TONGUE WAS FLAILING TO THE POINT OF CHOCKING HIM. HE SAID HE ENDED UP IN THE EMERGENCY ROOM SINCE HE WAS LOSING OXYGEN. ON THEIR WAY TO THE ER HIS NEPHEW WAS TALKING TO THE INSPIRE PEOPLE AND THEY TOLD HIM TO CHANGE THE BATTERY FOR THE MOUSE. THAT WAS WHEN THE DEVICE WAS DEACTIVATED. WHEN HE STARTED TALKING AGAIN HIS TONGUE WAS HAVING OUT-OF-CONTROL MOVEMENT. HE SAID HE CONTACTED INSPIRE SO MANY TIMES. (B)(6) OF THIS YEAR, THEY SENT A REPRESENTATIVE FOR THE FIRST TIME. THE INSPIRE PERSON BY THE NAME OF (B)(4), TOLD HIM AND HIS WIFE THAT THEY DO NOT KNOW WHAT IS CAUSING IT. HE SAID, IN (B)(6) OF 2023, THE SURGEON TOLD HIM AND HIS WIFE, HE CANNOT REMOVE THE DEVICE BECAUSE OF THE PROXIMITY OF THE WIRE IN HYPOGLOSSAL NERVE IN THE NECK AND HIS VOCAL CORD. HE SAID THE IMPLANT CHANGED HIS LIFE EMOTIONALLY AND HE NO LONGER WANTS TO GO OUT AND MIX WITH PEOPLE, AFRAID THAT THE DEVICE WILL GO OFF.