Description of Event or Problem · 0
AS A MANDATED REPORTER, I SUBMIT TO THE FDA INFORMATION PERTINENT TO POST-MARKET SURVEILLANCE BECAUSE THE MANUFACTURE FAILED TO DO SO. THE FOLLOWING IS AN EXCERPT FROM "(B)(6). PMID: (B)(4). "WE REPORT THE CASE OF A PATIENT WITH LATE-LIFE DEPRESSION WHO UNDERWENT AMYLOID POSITRON EMISSION TOMOGRAPHY IMAGING BEFORE AND 20 MONTHS AFTER RIGHT UNILATERAL ECT. WE FOUND STRIKING ASYMMETRICAL AMYLOID BINDING AFTER ECT, SUGGESTING THAT ECT MIGHT INTERFERE WITH AMYLOID DEPOSITION IN THE BRAIN. "AN 82-YEAR-OLD WOMAN WITH MAJOR DEPRESSIVE DISORDER WITH MELANCHOLIC FEATURES WAS REFERRED TO THE DEPARTMENT OF OLD AGE PSYCHIATRY, UNIVERSITY PSYCHIATRIC CENTRE, (B)(6), BELGIUM. SHE HAD NO SIGNIFICANT MEDICAL HISTORY EXCEPT FOR MAJOR DEPRESSIVE DISORDER DIAGNOSED AT AGE 38 THAT WAS TREATED PHARMACOLOGICALLY. MONTGOMERY¿ÅSBERG DEPRESSION RATING SCALE AND MINI-MENTAL STATE EXAMINATION SCORES AT ADMISSION WERE 33/60 AND 25/30, RESPECTIVELY. BEFORE ECT, THE PATIENT UNDERWENT A NEUROPSYCHOLOGICAL EXAMINATION SHOWING MEMORY IMPAIRMENT BUT PRESERVED GENERAL COGNITIVE FUNCTIONING (TABLE 1). AFTER THE PATIENT GAVE WRITTEN INFORMED CONSENT FOR ECT AND THE STUDY PROTOCOL AND AFTER DISCONTINUATION OF PAROXETINE 20 MG, ECT WAS ADMINISTERED TWICE WEEKLY WITH A CONSTANT-CURRENT BRIEF-PULSE DEVICE (THYMATRON SYSTEM IV; SOMATICS, LLC, (B)(6), ILLINOIS). SHE WAS TREATED WITH RIGHT UNILATERAL ECT (D'ELIA POSITION) WITH STIMULUS INTENSITY SIX TIMES THE INITIAL SEIZURE THRESHOLD (PULSE WIDTH 1 MS, FREQUENCY 70 HZ, TRAIN 8 SECONDS, 200 J). THE ECT WAS CONTINUED UNTIL SUSTAINED REMISSION (MONTGOMERY¿ÅSBERG DEPRESSION RATING SCALE ,10 IN TWO CONSECUTIVE RATINGS WITH 1-WEEK INTERVAL), WHICH WAS AFTER 14 SESSIONS. AFTER ECT, NORTRIPTYLINE WAS STARTED AS MAINTENANCE THERAPY (75 MG/DAY). THE PATIENT UNDERWENT AMYLOID POSITRON EMISSION TOMOGRAPHY (HI-REZ PET-CT; SIEMENS MEDICAL SYSTEMS, ERLANGEN, GERMANY) 1 DAY BEFORE ECT AND 20 MONTHS AFTER THE LAST ECT SESSION. AS PART OF AN INVESTIGATOR-INITIATED STUDY, 18FFLUTEMETAMOL, THE FLUOR-LABELED PITTSBURGH COMPOUND B (PIB) DERIVATIVE, WAS USED AS A RADIOLIGAND BEFORE ECT. THE PATIENT UNDERWENT SCANNING AGAIN 20 MONTHS AFTER ECT AS PART OF THE CLINICAL WORK-UP USING 11C-PIB. 18F-FLUTEMETAMOL AND 11C-PIB SCANS WERE PROCESSED IDENTICALLY (4) USING MAGNETIC RESONANCE IMAGING OF THE PATIENT (FIGURE 1A) FOR COREGISTRATION AND NORMALIZATION. TO ACCOUNT FOR DIFFERENCES IN RADIOLIGAND USED BEFORE AND AFTER ECT, WE ADDITIONALLY CREATED TRACER-SPECIFIC Z-MAPS BASED ON 20 AMYLOID-NEGATIVE HEALTHY OLDER SUBJECTS WHO UNDERWENT 18F-FLUTEMETAMOL AND 11C-PIB SCANNING. FURTHERMORE, WE CALCULATED MEAN STANDARD UPTAKE VALUE RATIOS (SUVRS) IN THE FOLLOWING VOLUMES OF INTEREST (VOIS): LATERAL FRONTAL, LATERAL PARIETAL, LATERAL TEMPORAL CORTEX, ANTERIOR CINGULATE, POSTERIOR CINGULATE, MEDIAL TEMPORAL CORTEX, OCCIPITAL CORTEX, AND STRIATUM USING THE AUTOMATIC ANATOMIC LABELING ATLAS. A COMPOSITE CORTICAL VOI AS THE AVERAGE OF LATERAL FRONTAL, LATERAL PARIETAL, LATERAL TEMPORAL CORTEX, ANTERIOR CINGULATE, AND POSTERIOR CINGULATE WAS USED TO DETERMINE CORTICAL AMYLOID LOAD (5). "OUR COMPARISONS BEFORE AND AFTER ECT SHOW AN INCREASE IN AMYLOID BINDING IN BOTH HEMISPHERES BUT SIGNIFICANTLY LESS IN THE RIGHT HEMISPHERE THAN IN THE LEFT HEMISPHERE, POINTING TO A RELATIVE REDUCTION IN ?-AMYLOID ACCUMULATION IN THE STIMULATED HEMISPHERE. TOGETHER WITH EVIDENCE FOR LATERALIZED NEURAL TISSUE EFFECTS AFTER UNILATERAL ECT (6,7), OUR CASE SUGGESTS THAT ECT MIGHT INTERFERE WITH AMYLOID D DEPOSITION IN VIVO." PATIENTS, FAMILIES, GUARDIANS AND THOSE MAKING TREATMENT CHOICES ON BEHALF OF THE MOST VULNERABLE DESERVE TO MAKE INFORMED TREATMENT CHOICES. IF JUST 14 TREATMENTS CAN DO THIS TO A PATIENT, WHAT DOES MAINTENANCE OR CONTINUOUS ECT DO TO AMYLOID PROTEIN BUILD-UP IN THE BRAIN. THIS PARTICULAR PATIENT IS 82 YEARS OLD. WHAT ABOUT KIDS AND ANYONE ELSE YOUNGER THAN 82 GETTING ECT WHO HAVE THEIR WHOLE LIVES AHEAD OF THEM. THE FDA MUST DO THEIR DUE DILIGENCE BECAUSE CLEARLY ECT MANUFACTURES WON'T. THIS CASE STUDY WAS PUBLISHED BACK IN 2015, YET THE FDA HAS NO RECORD OF IT SUBMITTED TO YOU BY SOMATICS, LLC--BEGGING THE QUESTION, WHAT ELSE HAVEN'T THEY SUBMITTED? LEST WE FORGET, 21 CFR PART 882 (PAGES 66120-1) STATES: "IF A PMA IS NOT FILED WITHIN 90 DAYS AFTER THE ISSUANCE OF A FINAL ORDER, AND THE DEVICE IS NOT DISTRIBUTED FOR INVESTIGATIONAL USE UNDER AN IDE, THE DEVICE IS DEEMED TO BE ADULTERATED WITHIN THE MEANING OF SECTION 501(F)(1)(A) OF THE FD&C ACT, AND SUBJECT TO SEIZURE AND CONDEMNATION UNDER SECTION 304 OF THE FD&C ACT (21 U.S.C. 334) IF ITS DISTRIBUTION CONTINUES. "IF A PMA FOR A CLASS III DEVICE IS NOT FILED WITH FDA BY (B)(6), 2019, THE DEVICE WILL BE DEEMED ADULTERATED UNDER SECTION 501(F) OF THE FD&C ACT. "IF A 510(K) AMENDMENT IS NOT SUBMITTED BY (B)(6), 2019 OR IF FDA DETERMINES THAT THE AMENDMENT DOES NOT DEMONSTRATE COMPLIANCE WITH THE SPECIAL CONTROLS, THE DEVICE MAY BE CONSIDERED ADULTERATED UNDER SECTION 501 (F)(1)(A) OF THE FD&C ACT, AND SUBJECT TO SEIZURE AND CONDEMNATION UNDER SECTION 304 OF THE FD&C ACT (21 U.S.C. 334) IF ITS DISTRIBUTION CONTINUES. OTHER ENFORCEMENT ACTIONS INCLUDE BUT ARE NOT LIMITED TO, THE FOLLOWING: SHIPMENT OF DEVICES IN INTERSTATE COMMERCE WILL BE SUBJECT TO INJUNCTION, INDIVIDUALS RESPONSIBLE FOR SUCH SHIPMENT WILL BE SUBJECTED TO PROSECUTION. IT'S BEEN 4 YEARS. KEEP YOUR PROMISE.