Description of Event or Problem · 0
THE REASON FOR CALL WAS PATIENT WAS INQUIRING ABOUT COMPATIBILITY WITH THE PHILLIPS CPAP MASK/MACHINE. PATIENT SAID EVERY TIME THEY USE THEIR CPAP MACHINE, THEY BURN AND THEY ARE FEELING IT ON THE RIGHT SIDE OF THEIR HIP, THE OTHER SIDE OF THEIR HIP AND IN THEIR SPINE. PATIENT ALSO SAID THEY WERE HAVING PROBLEMS WITH DRY EYES. PATIENT SAID THEY ONLY FEEL THIS SENSATION WHEN USING THE CPAP MACHINE. PATIENT SAID THEY SAW THEIR DOCTOR THAT PRESCRIBED THE CPAP AND THE DOCTOR SAID THE CPAP SHOULDN'T BOTHER THEM WITH THEIR STIMULATOR (FOR INTERSTIM). PATIENT SAID THEY STARTED USING THIS MACHINE (B)(6) AND THEY STOPPED USING IT LAST NIGHT (B)(6) 2022 BECAUSE OF THE SENSATION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT CLARIFYING THAT THE BURNING SENSATION WAS NOT FROM THE CPAP MACHINE, AND THEY STATED THAT THEY HAD GOTTEN MD HEARING AIDS AND HAD THEM ON AND THEY WERE CHANGING THE SETTING ON THEIR "STIN CELL" (UNDERSTOOD AS STIMULATOR) THAT THEY HAD FOR THEIR BOWELS. THE PATIENT FIGURED THE CAUSE OUT THEMSELVES AS WHEN THEY DIDN'T HAVE THEIR HEARING AIDS IN IT STOPPED. THEY STATED THAT IT HAD NOTHING TO DO WITH THE "MACHINE" OR THE CPAP. THE ISSUE WAS RESOLVED BY PROCESS OF ELIMINATION, AND THEY STATED THAT THERE WILL BE NO FURTHER ACTIONS TAKEN. THE PATIENT WEIGHED 201 POUNDS AT THE TIME OF THE EVENT. MEDTRONIC REFERENCE NUMBER: (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).