Description of Event or Problem · 1
I HAVE A MEDTRONIC SYNCHROMED II 8637-20. IMPLANTED. THE PUMP HAS SOME SAFETY MEASURES BUILT IN THAT DO NOT FUNCTION PROPERLY. I HAD AN MRI PERFORMED AND THE NEXT DAY WENT TO HAVE THE PUMP CHECKED TO MAKE SURE IT WAS STILL FUNCTIONING. THE CHECK OF THE PUMP SHOWED THAT IT HAD TURNED OFF AT THE TIME OF THE MRI. I HAD THE PUMP RESTARTED USING THE SCANNER AT MY DOCTOR'S OFFICE. THE PUMP CAN TURN OFF, BUT SHOULD RESTART AND THERE IS A CRITICAL ALARM BUILT IN THAT IS SET TO GO OFF EVERY TEN MINUTES IF IT STALLS OR MALFUNCTIONS OR GETS LOW ON THE MEDICINE. NOT ONLY DID THE PUMP STALL BUT THE ALARM FAILED TO SOUND. AFTER THE INITIAL SCAN THE NEXT DAY AFTER THE MRI, THE ALARM SOUNDED AND WAS HEARD EASILY BY MYSELF, MY HUSBAND, AND THE NURSE THAT WAS SCANNING IT. SHE SAID SHE WOULD NOTIFY THE MEDTRONIC REPRESENTATIVE REGARDING THE MOTOR STALL AND THE FAILURE OF THE ALARM TO ACTIVATE. SHE LATER CALLED AND TOLD ME THAT THE REP SAID, WE MIGHT NOT HAVE HEARD THE ALARM WHICH IS WRONG AS IT IS LOUD ENOUGH NOT TO MISS IT AND IT SHOULD HAVE BEEN GOING OFF EVERY TEN MINUTES. SHE ALSO STATED, THAT THE MRI STRENGTH SHOULD BE FINE IF AT 1.5 TESLA (NOT SURE ON SPELLING). THE MRI TECH SAID, IT WAS 1.5. THIS IS THE SECOND TIME THIS HAS HAPPENED WITH THIS TYPE OF PUMP. THE LAST ONE I HAD TURNED OFF FOR 10 DAYS AFTER AN MRI AND WHEN I DEVELOPED SYMPTOMS FROM NOT GETTING THE MEDICINE (BACLOFEN/MORPHINE) I WENT AND HAD THE PUMP CHECKED BY SCANNER AND AT THAT TIME, LEARNED IT HAD SHUTDOWN DURING AN MRI AND AGAIN NO ALARM SOUNDED THE ENTIRE 10 DAY PERIOD. WE DEMANDED THAT THE FIRST ONE BE REPLACED AND HAD A NEW ONE IMPLANTED IN 2007. THIS FAILURE OF THE PUMP CAN LEAD TO DEATH IF THE MEDICINE CONCENTRATION IS HIGH ENOUGH. MY DOCTOR SAID I AM AT A DOSAGE THAT IS LOW ENOUGH THAT IT ISN'T CRITICAL IF THE PUMP FAILS, BUT OTHER PEOPLE COULD HAVE THE SAME PROBLEM WHO HAVE HIGHER CONCENTRATIONS. BEFORE ALL MY MRI'S I MAKE SURE THAT THE MRI STRENGTH IS AT 1.5 TESLAS. ON THE INCIDENT WITH THE FIRST PUMP, WHEN I HAD IT CHECKED AFTER THE TEN DAY, THE MEDTRONIC REP RESTARTED IT WITH THE SCANNER AND ACTIVATED THE ALARM TO MAKE SURE IT WAS WORKING AND THE ALARM COULD BE HEARD LOUD AND CLEAR. AT NO TIME DURING THE TEN DAY PERIOD DID THE ALARM SOUND, SO WE HAD NO IDEA THAT THE MOTOR HAD STALLED UNTIL SYMPTOMS OCCURRED. THE NURSE WHO CONTACTED THE MEDTRONICS REP ALSO RELATED THAT THE REP TOLD HER THERE WERE A HANDFUL OF THESE PUMPS NOT COMING BACK ON AFTER THE MRI'S AND THEY HAD NO EXPLANATION FOR THE ALARM NOT FUNCTIONING.