SUGITA ANEURYSM CLIP

Description of Event or Problem

IT WAS REPORTED THE PATIENT WANTED TO KNOW ABOUT MRI COMPATIBILITY WITH THEIR SUGITA ANEURYSM CLIP" THAT THEY HAVE HAD FOR YEARS. AGENT REVIEWED THIS IS NOT A MEDTRONIC PRODUCT AND COULD NOT PROVIDE ANY GUIDELINES. PT THEN MENTIONED THEY HAVE TO HAVE AN MRI AND THEY WERE TOLD THEY WOULD NOT DO THE MRI UNTIL PT GOT INFORMATION ON THE CLIP THAT WAS IMPLANTED. PT STATES THEY HAVE HAD ABOUT 8 MRI'S AND AFTER THE MRI THE PT HAS A "WEIRD HEADACHE FOR 2 DAYS AFTER HAVING THE MRI". "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".