Description of Event or Problem · 0
THE PATIENT HAS AN INSPIRE IMPLANT FOR SLEEP APNEA: MODEL 3028-GENERATOR, INSPIRE SENSING AND STIMULATION LEAD. SCHEDULED FOR MRI SHOULDER ON (B)(6) 2024. AFTER FURTHER INVESTIGATION AND REVIEW, MANUFACTURER GUIDELINES WERE STRICTLY FOLLOWED. PRE-PROCEDURE: THE PATIENT WAS SCREENED BY A LEVEL 2 TRAINED MRI TECHNOLOGIST AND CHANGED INTO APPROVED HOSPITAL ATTIRE FOR PERFORMING THE MRI PROCEDURE. A FERRO-DETECTION DEVICE WAS UTILIZED TO SCREEN THE PATIENT FOR ANY FERROUS MATERIALS. THE PATIENT HAD THEIR REMOTE AND GENERATOR FULLY CHARGED. IN ZONE III OF MRI, THE PATIENT USED THE REMOTE TO TURN ON STIMULATION/THERAPY AND THE LEVEL 2 TRAINED MRI TECHNOLOGIST WITNESSED THAT THE DEVICE WAS FUNCTIONING PROPERLY. THE PATIENT TURNED OFF STIMULATION/THERAPY AND THE LEVEL 2 TRAINED MRI TECHNOLOGIST WITNESSED THAT STIMULATION/THERAPY WAS OFF. THE REMOTE WAS LEFT IN ZONE III. THE PATIENT WAS THEN ESCORTED INTO ZONE IV BY A LEVEL 2 TRAINED MRI TECHNOLOGIST TO HAVE THEIR MRI SHOULDER PROCEDURE. THE PATIENT WAS PROVIDED A CALL BUTTON AND INSTRUCTED TO INFORM THE MRI TECHNOLOGIST IF THEY EXPERIENCED ANY DISCOMFORT OR PAIN DURING THE PROCEDURE, TO NOTIFY THEM IMMEDIATELY. THE MRI TECHNOLOGIST VISUALLY MONITORED THE PATIENT DURING THE PROCEDURE. DEVICE SCANNING CONDITION 5 USED FOR THIS PROCEDURE, BASED ON MANUFACTURER GUIDELINES: I: MAX STATIC FIELD STRENGTH: 1.5T/HORIZONTAL CLOSED BORE. II: CIRCULAR POLARIZED. III: STIMULATION/THERAPY: TURNED OFF. IV: MAX SPATIAL GRADIENT: 30 T/M OR 3000 G/CM OR LESS. V: MAX SLEW RATE: 200 T/M/S OR LESS. VI: TRANSMIT COIL: INTEGRATED WHOLE BODY BUILT IN. VII: RECEIVE COIL: ANY. VIII: SCAN REGION: ISO-CENTER OF THE SCAN AT OR SUPERIOR TO T12 VERTEBRA. IX: SCAN TIME RESTRICTIONS: 30 MINUTES OF ACTIVE SCAN TIME IN A 90 MINUTE WINDOW, 60 MINUTES OF DOWNTIME BETWEEN SCANNING SESSIONS. X: MAX B1 + RMS: 1.9 UT OR LESS. THE MRI PROCEDURE WAS APPROXIMATELY 15 TO 20 MINUTES IN DURATION. THE PATIENT DID NOT SHOW ANY SIGNS OF DISTRESS AND DID NOT SQUEEZE THE CALL BUTTON. UPON COMPLETION OF THE PROCEDURE, THE TECHNOLOGIST ENTERED ZONE IV AND DISCOVERED THAT THE PATIENTS TONGUE WAS MOVED INTO A FORWARD POSITION. THE PATIENT EXITED ZONE IV AND THE LEVEL 2 TECHNOLOGIST HAD THE PATIENT TEST THEIR DEVICE. THE PATIENT HAD TO TURN OFF THEIR INSPIRE IMPLANT DEVICE AFTER THE MRI PROCEDURE. AFTER SPEAKING WITH THE PATIENT, THEY STATED THAT THE DEVICE TURNED ON IMMEDIATELY AFTER THE PROCEDURE BEGAN. THE PATIENT ALSO STATED THAT THE TONGUE WAS MOVING WITH THE SOUND OF THE GRADIENTS IN THE MRI SCANNER. THE PATIENT THOUGHT THIS WAS NORMAL AND DID NOT EXPERIENCE ANY DISCOMFORT OR PAIN. THE MRI SUPERVISOR/MRSO WAS CONTACTED AND INFORMED OF THE EVENT. THE PATIENTS DEVICE WAS WORKING AND THEY DID NOT WANT TO GO TO THE ER (EMERGENCY ROOM). THE PATIENT WAS INSTRUCTED TO CONTACT INSPIRE AND THEIR DEVICE MANAGING CLINICIAN THE NEXT MORNING SINCE THIS OCCURRED AFTER HOURS. THE PATIENT WAS ALSO INSTRUCTED TO GO TO THE ER IMMEDIATELY IF THERE WERE ANY CHANGES OR ISSUES WITH THEIR DEVICE. THE PATIENT WAS CONTACTED THE NEXT DAY, FOLLOW-UP APPOINTMENT WAS MADE, AND THE PATIENT'S DEVICE WAS WORKING. AFTER FURTHER INVESTIGATION AND DISCUSSION WITH MRMD, ENT SPECIALIST, AND INSPIRE, IT WAS DETERMINED THAT THIS WAS POSSIBLY A DEVICE MALFUNCTION AND THERE WAS NO HARM TO THE PATIENT. INCIDENT REPORT, QUARTERLY MRI SAFETY REPORTING, AND FURTHER EDUCATION AND RESEARCH IS STILL BEING CONDUCTED. THIS WAS A POSSIBLE MEDICAL DEVICE MALFUNCTION AND THE PATIENT EXPERIENCED NO HARM. CLOSE CALL RESULTED IN PROVIDING THE PATIENTS MORE EDUCATION PRIOR TO THE MRI PROCEDURE.