Description of Event or Problem · 0
IN HONOR OF WOMEN'S DAY AND ALERT THE FDA OF THEIR OWN GROSS NEGLIGENCE IN POSTPONING THE "ADULTERATION" DECISION REGARDING GRANDFATHERED MEDICAL DEVICES WITHOUT PMA OR PDP ON WOMEN AS PROMISED (HTTPS://WWW.FEDERALREGISTER.GOV/D/2018-27809/P-37), I CHOOSE TO ACT AS A MANDATED REPORTER. I SUBMIT THIS ARTICLE ON BEHALF OF THE AUTHORS AS A MORAL OBLIGATION TO CLOSE THE GAP BETWEEN ECT RESEARCH CLINICAL OUTCOMES. SPEAKING OF ECT IN PREGNANCY: PATIENT WAS A 33-YEAR-OLD GRAVIDA 0 PARA 0 AND HAD BEEN DIAGNOSED WITH MDD AT THE AGE OF 26 YEARS. ALTHOUGH DULOXETINE HAD IMPROVED HER DEPRESSIVE SYMPTOMS, SHE HAD A RELAPSE OF MDD AT AROUND 13 WEEKS' GESTATION AFTER CESSATION OF DULOXETINE BECAUSE OF PREGNANCY AT 5 WEEKS' GESTATION. HER DEPRESSIVE SYMPTOMS THEN WORSENED DESPITE RESUMING DULOXETINE AND SHE FINALLY ATTEMPTED SUICIDE. SHE WAS ADMITTED TO OUR HOSPITAL AT 26 WEEKS' GESTATION. SHE DID NOT RESPOND TO DULOXETINE 40 MG/DAY AND EXPERIENCED LOSS OF APPETITE AND SUSTAINED SUICIDAL IDEATION. SHE COULD NOT TOLERATE THE ADVERSE EFFECTS OF DULOXETINE 60 MG/DAY OR ARIPIPRAZOLE 3 MG/DAY AS AUGMENTATION THERAPY (BOTH RESULTED IN HEADACHE). A SWITCH TO IMIPRAMINE 25 MG/DAY CAUSED AKATHISIA, SO DULOXETINE 40 MG/DAY WAS RESUMED BECAUSE IT WAS TOLERATED. ECT WAS THEN PROPOSED AS AN ADJUNCTIVE TREATMENT. AFTER OBTAINING INFORMED CONSENT FROM THE PATIENT AND HER FAMILY MEMBERS [WE DIDN'T TELL THEM ABOUT RISK TO BABY (HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/24271084) OR THAT ACUTE BRADYCARDIA AND ASYSTOLE WERE COMMON IN ECT (DOI: 10.1097/YCT.0000000000000859) ], WE ADMINISTERED A BILATERAL BRIEF PULSE OF ECT TO ACHIEVE A RAPID RESPONSE [9] AND IMPROVE HER SUICIDAL IDEATION [10]. THE PATIENT UNDERWENT THE FIRST APPLICATION OF ECT AT 30 WEEKS' GESTATION AND FHR WAS MONITORED BY OBSTETRICIANS AND PEDIATRICIANS USING CARDIOTOCOGRAPHY AND FETAL ECHOCARDIOGRAPHY BEFORE AND AFTER ECT. ECT WAS ADMINISTERED TWICE A WEEK USING A TYMATRON SYSTEM IV MACHINE. ALL ECT SESSIONS USED AN ELECTRICAL STIMULUS OF 10%¿25% TO INDUCE THE APPROPRIATE GENERALIZED CEREBRAL SEIZURE WITH GOOD EFFICACY. THE FIRST AND SECOND SESSIONS OF ECT CAUSED FETAL TACHYCARDIA ?180 BPM FOR MORE THAN 30 MINUTES. AT FIRST, WE ASSUMED THAT THE FIRST STIMULUS DOSE OF ECT HAD BEEN SO HIGH THAT FETAL TACHYCARDIA HAD OCCURRED, SO THE STIMULUS DOSE WAS LOWERED IN THE SECOND SESSION. NEVERTHELESS, FETAL TACHYCARDIA OCCURRED DURING THE SECOND SESSION OF ECT; WE CONSIDERED THAT THE LENGTH OF MATERNAL APNEA AFFECTED THE FETAL CARDIAC SYMPTOMS, SO WE STARTED OXYGENATION JUST AFTER THE ELECTRIC STIMULUS. THE FETUS DID NOT HAVE PERSISTENT ELEVATION OF FHR IN THE THIRD, FOURTH, AND FIFTH SESSIONS OF ECT. MEANWHILE, CARDIOTOCOGRAPHY RECORDED UTERINE CONTRACTIONS AFTER ECT FROM THE THIRD SESSION ONWARD. ON THE SIXTH SESSION OF ECT, FHR MONITORING SHOWED TACHYCARDIA FOR AROUND 120 MINUTES AGAIN. DURING MONITORING, THOUGH CARDIOTOCOGRAPHY DID NOT SHOW ACCELERATION, BASELINE VARIABILITY WAS WITHIN NORMAL LIMITS AND DECELERATIONS WERE NOT SEEN. WE WERE CONCERNED ABOUT THE RISK OF PRETERM LABOR CAUSED BY ADMINISTRATION OF ECT AND DECIDED TO TERMINATE ECT BECAUSE THE UTERINE CONTRACTIONS HAD BEEN LONGER AT THE MOST RECENT SESSION (LASTING AROUND 120 MINUTES) THAN PREVIOUSLY, AND THE RISKS OF CONTINUING ECT BY THEN OUTWEIGHED THE BENEFITS. (WATANABE A, AYANI N, WARATANI M, ET AL. A CASE OF FETAL TACHYCARDIA AFTER ELECTROCONVULSIVE THERAPY: A POSSIBLE EFFECT OF MATERNAL HYPOXIA AND UTERINE CONTRACTIONS. CASE REP PSYCHIATRY. 2019;2019:3709612. DOI:10.1155/2019/3709612). YOU KNOW THE US FDA HAS NOT RECEIVED ANY PMA OR PDP FOR ANY ECT DEVICES BEFORE YOUR ESTABLISHED DEADLINE FOR CLASS II AND CLASS III USE. HTTPS://WWW.FEDERALREGISTER.GOV/D/2018-27809/P-37 THIS DEVICE SHOULD BE ADULTERATED. DO YOUR DUE DILIGENCE.