Description of Event or Problem · 1
(B)(6) OLD MALE PATIENT WITH FACIAL ACTINIC KERATOSES (AK'S) WHO WAS TREATED FOR THE FIRST TIME WITH LEVULAN KERASTICK 20% TOPICAL SOLUTION AND BLU-U PHOTODYNAMIC THERAPY (PDT) ON THE NOSE AND CHEEKS (FACE) ON (B)(6) 2013. PRE-TREATMENT SKIN PREP CONSISTED OF AN ALCOHOL WIPE AND DRYING OF THE FACE. LEVULAN WAS APPLIED TO HIS NOSE AND CHEEKS, WITH AN INCUBATION TIME OF ONE HOUR, FOLLOWED BY BLU-U LIGHT EXPOSURE WITH 16 MINUTES 40 SECONDS. THE PATIENT TOLERATED THE TREATMENT WITH NO COMPLAINTS, LEFT THE DERMATOLOGIST OFFICE IN STABLE CONDITION AND DROVE HOME, REPORTEDLY 1.5 HRS. ON (B)(6) 2013, TWO DAYS POST TREATMENT, HE EXPERIENCED A SEIZURE, WAS TAKEN TO THE HOSPITAL FOR EVALUATION, AND ADMITTED. AN MRI WAS SCHEDULED FOR (B)(6) 2013, PATIENT REMAINS HOSPITALIZED, AND THE CAUSE OF THE SEIZURE IS STILL UNKNOWN. THERE IS NO MEDICAL HISTORY OF SEIZURE DISORDER, OR CONCOMITANT MEDICATIONS TO INDICATE SUCH. ON (B)(6) 2013 THE PATIENT'S WIFE REPORTED: TWO DAYS POST TREATMENT (B)(6) 2013, AT ABOUT 6:50 AM, SHE AWOKE TO FIND HER HUSBAND WAS HAVING A SEIZURE. EMERGENCY MEDICAL TREATMENT (EMT'S) TRANSPORTED HIM TO THE HOSPITAL. WHEN SHE ARRIVED AT THE HOSPITAL, SHORTLY AFTER HER HUSBAND ARRIVED, SHE REPORTS HER HUSBAND WAS INTUBATED AND SEDATED. HE WAS ADMITTED TO THE CARDIAC INTENSIVE CARE UNIT (CICU), WHERE HE WAS MONITORED WITH CONTINUOUS EEG, AND SEDATION (VERSED). SHE REPORTS THAT HE CONTINUED TO HAVE SEIZURES FOR THE NEXT TWO DAYS. AN MRI WAS DONE AND THE RESULTS WERE "UNREMARKABLE." THE VERSED WAS DECREASED IN SMALL DOSES WHILE THEY KEPT THE SEIZURES UNDER CONTROL. AFTER THE SEIZURE ACTIVITY STOPPED, AND BEING COMPLETELY WEANED FROM THE VERSED FOR ONE DAY, HE WAS TAKEN OFF THE VENT AND HAS MAINTAINED A GOOD OXYGEN LEVEL OF 95%. HE IS BEING CONSIDERED FOR TRANSFER TO A STEP DOWN NEURO UNIT. THE WIFE REPORTED HE IS AWAKE, ALERT, AND ORIENTED TO PERSON, PLACE AND TIME, AND GETTING OUT OF BED TO THE CHAIR TODAY, FOR THE FIRST TIME. SHE FURTHER REPORTED THAT THE PHYSICIANS ARE UNSURE AS TO THE CAUSE OF THE SEIZURES, BUT THAT THEY HAVE RULED OUT INFECTION AND THE MRI RULED OUT ANY BRAIN PROBLEMS. IT IS THE OPINION OF THE COMPANY'S CHIEF MEDICAL OFFICER (CMO) THAT THE TIME OF THE SEIZURE AS BEING 2 DAYS POST PDT AS WELL AS UNEVENTFUL RESPONSES TO LEVULAN PDT SUGGEST TO ME THAT THE PDT TREATMENT IS UNRELATED TO THE SEIZURE EPISODE.