Description of Event or Problem · 1
IT WAS REPORTED VIA A CALL FROM A PHYSICIAN AT THE HOSPITAL IN THE INTENSIVE CARE UNIT, THAT THEY HAD A VNS PATIENT WHO WAS HOSPITALIZED DUE TO EPISODES OF BRADYCARDIA AND HYPOTENSION. THE PATIENT'S HEART RATE HAD DROPPED IN THE 30 BPM RANGE, AND THE BLOOD PRESSURE WOULD FALL TO 68/40, AND 70/40. THE PHYSICIAN HAD CONTACTED CYBERONICS INDICATING THAT THEY WOULD LIKE TO HAVE THE VNS DEVICE CHECKED, AND IT WAS NOTED THAT THE PATIENT'S TREATING PHYSICIAN, WHO IS NOT AFFILIATED WITH THE HOSPITAL, WOULD NOT HAVE RIGHTS IN THEIR HOSPITAL. THE REPORTER INDICATED THAT THE PATIENT WAS EVALUATED BY A CARDIOLOGIST AND THEY WERE CONSIDERING IMPLANTING A PACEMAKER. THE PHYSICIAN WAS QUESTIONING WHETHER THE CARDIAC EVENTS WERE RELATED TO THE VNS. THE PHYSICIAN EXPLAINED THAT THE EVENTS WERE OCCURRING INTERMITTENTLY, AND EXPLAINED THAT THE PATIENT WOULD BE IN THE HOSPITAL ROOM AND BRADYCARDIA/HYPOTENSION WOULD OCCUR INTERMITTENTLY AND THEN THE PATIENT WOULD BE BROUGHT TO THE ICU. THE PHYSICIAN STATED THERE HAD BEEN NO OTHER MEDICATION CHANGES OR OTHER ISSUES THAT WOULD HAVE CONTRIBUTED TO THE BRADYCARDIA/HYPOTENSION THAT SHE WAS AWARE OF. ADDITIONAL INFORMATION WAS RECEIVED REVEALING THAT A MANUFACTURER REPRESENTATIVE WENT TO THE HOSPITAL ACCOMPANIED BY AN EPILEPTOLOGIST TRAINED IN VNS THERAPY, WHO IS AFFILIATED WITH THE HOSPITAL. THE VNS DEVICE WAS INTERROGATED AND WAS PROGRAMMED TO 1MA/20HZ/250USEC/30SEC ON/5MIN OFF. A SYSTEM DIAGNOSTIC TEST WAS PERFORMED WHICH REVEALED NORMAL DEVICE FUNCTION, LEAD IMPEDANCE WAS OK, IMPEDANCE VALUE 2715 OHMS, AND THE OUTPUT STATUS WAS OK. AFTER THE EPILEPTOLOGIST REVIEWED THE DEVICE SETTINGS, DIAGNOSTIC TEST RESULTS, AND THE PATIENT'S CHART, THE EPILEPTOLOGIST EXPLAINED THAT SHE DOES NOT FEEL THAT THE DEVICE IS CAUSING THE PROBLEMS AND THAT THE EVENTS ARE DUE TO THE PATIENT'S OTHER PROBLEMS, AND FURTHER NOTED THAT THE PATIENT IS "VERY COMPLICATED." THE PLAN WAS TO KEEP THE PATIENT HOSPITALIZED FOR ONE ADDITIONAL DAY FOR MONITORING. IT IS UNKNOWN AT THIS TIME WHAT INTERVENTIONS WERE TAKEN FOR THE CARDIAC EVENTS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PATIENT'S TREATING NEUROLOGIST ARE UNDERWAY, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE.