Description of Event or Problem · 1
PT WAS DIAGNOSED WITH SEIZURE DISORDER AND REPORTER HAD TRIED MULTIPLE MEDICATIONS WITH CONTINUED BREAK THROUGH IN SEIZURE ACTIVITY. THE MD'S RECOMMENDED THAT A VNS BE IMPLANTED TO DECREASE SEIZURE ACTIVITY. REPORTER WAS NOT MADE AWARE OF ALL OF THE POSSIBLE SIDE EFFECTS EITHER FROM CYBERONICS OR FROM PHYSICIANS. REPORTER WAS ONLY GIVEN THE PT MANUAL UPON COMPLETION OF IMPLANTATION OF THE DEVICE. AFTER READING THE VNS MESSAGE BOARD REPORTER HAS BEEN MADE AWARE OF SO MANY MORE SIDE EFFECTS THAN WERE EVER LISTED IN THE MANUAL, INCLUDING THE POSSIBILITY OF DEATH. PT HAS RETT'S SYNDROME AND IS UNABLE TO COMMUNICATE NEEDS AND UNABLE TO RELAY ANY ADVERSE REACTIONS THEY MAY BE EXPERIENCING. IT HAS COME TO REPORTER'S ATTENTION THAT THE EPILEPSY FOUNDATION DOES NOT RECOMMEND THAT THE VNS NOT BE IMPLANTED IN CHILDREN WITH RETT'S SYNDROME FOR THESE OBVIOUS REASONS RPTR HAS NOW BEEN MADE AWARE OF RECENTLY. PT HAS DECLINED IN A STEADY MANNER EVER SINCE THE IMPLANTATION. REPORTER INITIALLY THOUGHT THIS WAS DUE TO THE NORMAL PROGRESSION OF THEIR DISEASE; HOWEVER, IT WAS BROUGHT TO REPORTER'S ATTENTIION IN JULY OF 2003 THAT THERE WAS A POSSIBLITY THAT THE DEVICE MAY HAVE BEEN PUT IN WITH THE LEADS ON THE VAGAL NERVE INVERTED. THE NEUROLOGIST REQUESTED X-RAYS TO VERIFY THE PLACEMENT OF THE ELECTRODES, AT WHICH TIME REPORTER WAS INFORMED THAT THE LEADS WERE INVERTED. DUE TO THE INVERSION REPORTER MADE THE DECISION TO TURN OFF THE DEVICE TO SEE WHAT RESULTS WOULD FOLLOW. PT HAS SUFFERED SEVERE WEIGHT LOSS AND REQUIRED SURGERY FOR THE PLACEMENT OF A G-TUBE FOR SUPPLEMENTAL FEEDING. REPORTER LEARNED DURING THEIR INVESTIGATION ON THE VNS THERAPY MESSAGE BOARD THAT MULTIPLE PTS REPORT SEVERE LOSS OF APPETITE AND WEIGHT LOSS WITH THE VNS TURNED ON. THE PTS REPORT AFTER TURNING OFF THE DEVICE THAT THEY EVENTUALLY REGAINED THEIR APPETITE AND MAINTAINED THEIR WEIGHT, WHICH IS EXACTLY WHAT HAS HAPPENED TO PT. PTS HAVE ALSO REPORTED AN INCREASE IN SEIZURE ACTIVITY WITH THE VNS TURNED ON. PT HAS HAD A DECREASE IN SEIZURE ACTIVITY SINCE THE VNS HAS BEEN TURNED OFF. READING THE VNS MANUAL DOES NOT MENTION THE POSSIBLE SIDE EFFECT, BUT THE FDA WEB SITE REPORTS 1 OUT OF 5 RESEARCH CANDIDATES HAD AN INCREASE IN SEIZURE ACTIVITY WITH THE USE OF THE DEVICE. REPORTER WOULD LIKE TO REQUEST THAT FURTHER RESEARCH BY THE FDA BE DONE TO VALIDATE THAT THE VNS DEVICE IS A SAFE DEVICE TO CONTINUE TO BE IMPLANTED ESPECIALLY IN ANYONE WHO CANNOT COMMUNICATE THE POSSIBLE AND PROBABLE ADVERSE SIDE EFFECTS OF THE CONSTANT STIMULATION OF THE VAGAL NERVE. REPORTER FURTHER DOES NOT UNDERSTAND HOW CYBERONICS WAS MADE AWARE OF DR. PUTTING THE LEADS IN, IN AN INVERTED MANNER AND THEY DID NOTHING TO INFORM ALL POSSIBLE PTS WITH THE INVERSION. IT IS REPORTER'S UNDERSTANDING THAT THERE HAVE BEEN AT LEAST 30 PTS TO HAVE THE INVERSION OF THE LEADS TO THE VNS. CYBERONICS IS NOW LEADING REPORTERS TO BELIEVE THAT THE INVERSION HAS NO ADVERSE EFFECTS EVEN THOUGH THEY HAVE NO DATA OR RESEARCH RELIABLE ENOUGH TO MAKE THAT STATEMENT. IT IS REPORTER'S UNDERSTANDING THAT THE VNS IS TO BE IMPLANTED THE WAY THE FDA APPROVED AND IN NO OTHER MANNER.