Description of Event or Problem · 1
A FDA CLASS I RECALL OF MEDTRONIC'S SYNCHROMED II 8637 INFUSION PUMP WAS INITIATED (B)(6) 2011. ON (B)(6) 2011, THIS PUMP WAS SUPPLIED BY MEDTRONIC'S REP AND IMPLANTED IN MY MOTHER. THE PUMP WAS NOT FILLED WITH MORPHINE ON THAT DATE. ON (B)(6) 2011, THE SUTURES WERE REMOVED AND WE HAD EXPECTED THE PUMP TO BE FILLED WITH MORPHINE. WE WERE TOLD THAT THE MORPHINE HAD NOT BEEN APPROVED YET BUT THE FACT THAT THE PUMP WAS ALREADY IMPLANTED WOULD MAKE THE APPROVAL MORE LIKELY. ON (B)(6) 2011, THE PUMP WAS FILLED FOR THE FIRST TIME WITH MORPHINE AND THE PUMP DOSAGE SET AT .5 MG/DAY. MY MOTHER WAS SENT HOME WITH THE PUMP SET TO START AT 11:00 AM. WE WERE TOLD THAT SHE COULD POSSIBLY EXPERIENCE SOME NAUSEA AND IF IT GOT TOO BAD TO GET HER LOOKED AT. NO OTHER ADVERSE EFFECTS WERE POINTED OUT. MID-DAY SHE FELT GREAT AND AT 5:30 LAID DOWN FOR A NAP WHICH WAS NORMAL. WE WENT IN AT APPROXIMATELY 6:45 TO GET HER UP FOR DINNER AND FOUND SHE WAS AWAKE AND HAD JUST THROWN UP. WHILE CLEANING HER UP FOUND HER TO BE SOMEWHAT DISORIENTED, SO DECIDED TO TAKE HER TO EMERGENCY ROOM TO GET LOOKED AT. WHILE GETTING HER READY FOUND TO BE LESS COHERENT AND CALLED 911. FIRST RESPONDER TALKING WITH HER AND ACCESSING HER WHEN SHE THREW UP AGAIN AND STOPPED BREATHING. HE STATED THIS IS WHAT MORPHINE WILL DO AND STARTED LIFESAVING MEASURES AND CALLED IN ADDITIONAL MEDICS. THEY GAVE HER NARCAN AND SHE STARTED BREATHING ON HER OWN BUT STOPPED AGAIN ENROUTE TO THE EMERGENCY ROOM. EMERGENCY ROOM DOCTOR PUT HER ON RESPIRATOR AND CALLED THE PAIN DOCTOR TO GET THE PUMP TURNED OFF BUT RECEIVED NO CALL AFTER TWO ATTEMPTS. HOSPITAL CALLED AGAIN NEXT DAY TO BE TOLD CORRECT DOSAGE GIVEN. MEDTRONIC'S REP CAME TO HOSPITAL AND TURNED THE PUMP OFF. WE HAVE REVIEWED ALL INFO AVAILABLE AND FOUND THE PAIN DOCTOR DID NOT FOLLOW ANY OF THE WARNINGS FOR AN ELDERLY MORPHINE NAIVE PATIENT. THAT SHE SHOULD HAVE BEEN IN A FACILITY EQUIPPED FOR POSSIBLE ADVERSE REACTION OF RESPIRATORY ARREST. OUR CONCERN IS THAT THE RECALLED PUMP SHOULD NEVER HAVE BEEN PROVIDED, THAT THE MORPHINE SHOULD HAVE BEEN APPROVED AT SAME TIME AS THE PUMP AND PUT IN PUMP WHEN IMPLANTED AS SHE WAS THEN AT A MEDICAL FACILITY CAPABLE OF MONITORING HER CORRECTLY AND THAT THIS PAIN DOCTOR HAD NEGLIGENT PROTOCOL WITH SO MANY WARNINGS THAT WE WERE NOT AWARE OF UNTIL HER DEATH. I FIND MEDTRONIC AND (B)(6), DO RESPONSIBLE AS SHE SUFFERED BRAIN DAMAGE DUE TO THE RESPIRATORY ARREST AND SHE WAS REMOVED FROM THE RESPIRATOR ON (B)(6) 2011. I HAVE ATTEMPTED TO ADDRESS THIS WITH MEDTRONIC WITH NO RESPONSE. WHY IS IT LEGAL FOR THEM TO SUPPLY A MEDICAL DEVICE THAT WAS PREVIOUSLY RECALLED? IF NOT FOR THE AVAILABILITY OF THE DEVICE, SHE MIGHT VERY WELL STILL BE ALIVE AS IF WE WERE NOTIFIED OF THE NON-AVAILABLE STATUS DUE TO RECALL, WE SURELY WOULD HAVE NEVER HAD THE PROCEDURE DONE AFTER REVIEWING ALL THAT WE NOW KNOW. I WOULD LIKE A RESPONSE TO THIS QUESTION AND ALSO WHAT AVENUE TO TAKE TO GET THIS PAIN DOCTOR TO FOLLOW SAFE PROTOCOL PRACTICES. DUE TO THE AGE OF MY MOTHER IT SEEMS SHE IS NOT WORTHY OF A LAWSUIT AS SHE WAS NOT MONETARILY WORTH MUCH ACCORDING TO THE LAW. THANK YOU FOR YOUR ATTENTION AND YOUR RESPONSE. WE DO NOT KNOW WHAT BRAND OF MORPHINE WAS PUT INTO THE PUMP ON FIRST FILL DATE OF (B)(6) 2011. IT IS NOT SPECIFIED IN THE MEDICAL RECORDS. NOT EVEN SURE CORRECT DOSAGE WAS INTRODUCED AS THIS WAS GIVEN TO THE CORONER BY THE HOSPITAL AS THEY WANTED IT TESTED AND HE FELT IT WAS NOT NECESSARY. HE STATES SHE DIED FROM CORONARY FAILURE. I GUESS THAT IS WHAT TAKES PLACE AFTER THE RESPIRATOR IS TURNED OFF AND THE PATIENT STOPS BREATHING IN THEIR OWN. WHAT CAN I SAY, YES SHE WAS OLD BUT SHE WAS VALUABLE TO US.