Description of Event or Problem · 0
SINCE THE INFORMATION IN THE 2018, THYMATRON SYSTEM IV REGULATORY UPDATE WAS NOT SUBMITTED TO THE FDA BY THE DEVICE MANUFACTURES BEFORE THE FDA MADE THEIR RECLASSIFICATION DECISION. IT IS BEING SUBMITTED NOW BY A MANDATED REPORTER ON BEHALF OF THOSE WHO SHOULD HAVE SUBMITTED IT--BECAUSE THEY WERE GROSSLY NEGLIGENT IN NEGLECTING TO SEND THIS DEVICE UPDATE TO THE FDA. THE THYMATRON SYSTEM IV REGULATORY UPDATE PUBLISHED IN OCTOBER 2018 STATES (ON PAGE 4): REGULATORY UPDATE TO THYMATRON SYSTEM IV INSTRUCTION MANUAL COGNITIVE SIDE EFFECTS ARE EXPERIENCED IN VARYING TYPES AND SEVERITY BY ECT PATIENTS. STUDIES HAVE SHOWN THAT THE METHODS USED IN ECT ADMINISTRATION HAVE A SIGNIFICANT IMPACT ON THE NATURE AND MAGNITUDE OF COGNITIVE DEFICITS. IN GENERAL, THE AMERICAN PSYCHIATRIC ASSOCIATION RECOGNIZES THAT THE FOLLOWING TREATMENT PARAMETERS ARE EACH INDEPENDENTLY ASSOCIATED WITH MORE INTENSE COGNITIVE SIDE EFFECTS: BILATERAL ELECTRODE PLACEMENT; SINE WAVE STIMULATION; HIGH ELECTRICAL DOSAGE RELATIVE TO SEIZURE THRESHOLD; CLOSELY SPACED TREATMENTS; LARGER NUMBERS OF TREATMENTS; CONCOMITANT PSYCHOTROPIC MEDICATIONS; HIGH DOSAGE OF BARBITURATE ANESTHETIC AGENTS. ECT MAY RESULT IN ANTEROGRADE OR RETROGRADE AMNESIA. SUCH POST-TREATMENT AMNESIA TYPICALLY DISSIPATES OVER TIME; HOWEVER, INCOMPLETE RECOVERY IS POSSIBLE. IN RARE CASES, PATIENTS MAY EXPERIENCE PERMANENT MEMORY LOSS OR PERMANENT BRAIN DAMAGE. THE FULL REGULATORY UPDATE CAN BE DOWNLOADED FROM THE DEVICE MANUFACTURE'S WEBSITE. HTTP://WWW.THYMATRON.COM/DOWNLOADS/SYSTEM_IV_REGULATORY_UPDATE.PDF.