TOSHIBA

Description of Event or Problem

DURING A CERVICAL SPINE MRI, A PT STATED THAT SHE FELT BURNING STARTING IN HER NECK AND THEN WENT UP THROUGH TO HER FACE. SHE FELT IT ONLY FROM EARS FORWARD AND NOT IN THE BACK OF THE HEAD. SHE STARTED FEELING THE PAIN HALFWAY THROUGH THE EXAM, BUT DID NOT PRESS THE PT ALERT BALL BECAUSE, THE PT THOUGHT SHE WOULD JUST FINISH THE EXAM SINCE SHE HAD SO MANY MRI'S WITH NO PROBLEMS. WHEN SHE GOT UP FROM THE TABLE, HER FACE WAS RED AND SHE STATED THAT SHE LOOKED LIKE SHE HAD A SUNBURN. HER FACE WAS STILL RED WHEN SHE LEFT THE SITE. THE PT WAS INSTRUCTED TO CALL THE SITE IF SHE HAD ANY FURTHER ISSUES AND HAS NOT CALLED THE SITE BACK.

Additional Manufacturer Narrative

THE PT DID HAVE AN IMPLANT IN HER NECK AND DETAILS FOR THE IMPLANT HAVE BEEN REQUESTED. METHOD: AN INVESTIGATION IS IN THE PROCESS OF BEING PERFORMED. RESULTS: RESULTS WILL BE REPORTED WHEN THE INVESTIGATION IS COMPLETED. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN UNTIL THE INVESTIGATION IS COMPLETED.