FDA Adverse Event Injury Summary report: N

THYMATRON

MDR report key: 19162815 · Received April 23, 2024

Report

Report Number
MW5154064
Event Type
Injury
Date Received
April 23, 2024
Report Date
April 19, 2024
Manufacturer
SOMATICS, LLC.
Product Code
QGH
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
SP
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

A 55-YEAR-OLD WOMAN WAS REFERRED FOR ECT (ELECTROCONVULSIVE THERAPY) TO A CLINICAL PSYCHIATRIC DEPARTMENT THAT SPECIALIZES IN TREATMENT-RESISTANT DEPRESSION. THE NONPSYCHIATRIC HISTORY OF THE PATIENT CONSISTED OF AN ABSENCE OF DRUG ALLERGIES, HIGH BLOOD PRESSURE, DIABETES AND HIGH TOTAL CHOLESTEROL. SHE HAD SUFFERED FROM MENINGITIS AT THE AGE OF 35. TEN YEARS PREVIOUS TO REFERRAL SHE WAS DIAGNOSED WITH TYPE 1 NEUROFIBROMATOSIS. THE SYMPTOMS CONSISTED MAINLY OF OSSEOUS SIGNS AND WHITE COFFEE SPOTS. SHE DENIED DRUG ABUSE, INCLUDING TOBACCO USE. NO OPHTHALMOLOGIC ANTECEDENTS WERE REPORTED. THE PATIENT HAD NO REFRACTIVE DEFECT FROM ANY EYE TRAUMA AND HAD NOT UNDERGONE EYE SURGERY. THREE YEARS PRIOR TO REFERRAL, THE PATIENT BEGAN TO SUFFER FROM A DEPRESSIVE SYNDROME WHICH HAD NO APPARENT TRIGGER. SHE WAS DIAGNOSED WITH A MAJOR DEPRESSIVE DISORDER (DSM- IV-TR). HER OUTPATIENT MEDICATIONS INCLUDED SEVERAL ANTI- DEPRESSANT DRUGS AND ANXIOLYTICS. HER ADHERENCE WITH THE TREATMENT WAS IRREGULAR BECAUSE SHE EXPERIENCED SIDE EFFECTS. REMISSION FROM THE AFFECTIVE SYMPTOMS WAS PARTIAL, WITH CONTINUED DEPRESSED MOOD, PSYCHOMOTOR RETARDATION, ANXIETY, ANHEDONIA AND INSOMNIA. THE PATIENT'S CONDITIONS GRADUALLY WORSENED, WITH THE APPEARANCE OF SUICIDAL THOUGHTS IN THE LAST MONTH, WHICH LED TO HER BEING REFERRED FOR ECT. SHE PRESENTED NO PSYCHOTIC SYMPTOMS. HER HAMILTON DEPRESSION RATING SCALE (HDRS, HAMILTON, 1960) SCORE WAS 24. PRIOR TO ADMISSION, BOTH THE NEURO- IMAGE STUDY (BRAIN CT SCAN) AND NEUROPSYCHOLOGICAL EXPLORATION RESULTS WERE NORMAL. HER INPATIENT MEDICATION WAS PAROXETINE (30 MG/DAY), MIANSERIN (30 MG/DAY) AND CLONAZEPAM (1.5 MG/DAY). ECT BEGAN WITH BILATERAL PLACEMENT (THYRATRON SYSTEM DGX, 503.6 MC). ANESTHESIA FOR THE PROCEDURE INCLUDED INTRAVENOUS THIOPENTAL 150 MG (2¿2.5 MG/KG) AND SUCCINYLCHOLINE 30 MG (0.5 MG/KG) AND SHE WAS PREOXYGENATED. WITH THE USE OF THE AGE DOSING METHOD, 55% ENERGY WAS SET. THE DURATION OF ALL SEIZURES WAS 25 S OR MORE. SHE REPORTED VISUAL ALTERATIONS IN THE FORM OF BILATERAL DARK POINTS AND COBWEBS IMMEDIATELY AFTER RECOVERY FROM THE EIGHTH ECT SESSION. WHEN SHE WAS ASKED ABOUT THEM, THE PATIENT SAID THAT SHE HAD NOT NOTED THESE SYMPTOMS PRIOR TO THE ECT. THE CHARACTERISTICS OF THE EIGHTH SESSION WERE 55% ENERGY (277.2 MC), STATIC IMPEDANCE OF 1600, STIMULUS DURATION OF 2.2 S (CONSTANT CURRENT OF 0.9 A) AND FREQUENCY OF 70 HZ (CONSTANT PULSE WIDTH OF 1.0 MS). THE DURATION OF SEIZURE WAS 16 S MOTOR AND 33 S EEG. PREVIOUS AND POSTERIOR BLOOD PRESSURE, HEART RATE AND OXYGEN SATURATION WERE NORMAL. POST-ECT RECOVERY WAS UNCOMPLICATED UNTIL SHE REPORTED VISUAL ALTERATIONS. THE OPHTHALMOLOGIST WAS CONSULTED IMMEDIATELY. THE PATIENT'S VISUAL ACUITY WAS 100% IN BOTH EYES. A CONDENSED DETACHED POSTERIOR HYALOID WAS OBSERVED WITH NO OTHER ABNORMALITIES. THE CASE WAS CONSIDERED AS A BILATERAL PVD(PERIPHERAL VASCULAR DISEASE) AND RELATIVE REST WAS RECOMMENDED FOR 1 WEEK TO AVOID COMPLICATIONS. THE ECT WAS THUS STOPPED. THIS IS PARTICULARLY CONCERNING GIVEN A PUBLICATION INVESTIGATING INTRAOCULAR EYE PRESSURE IN PEOPLE RECEIVING "MODERN" AKA "MODIFIED" (WITH GENERAL ANESTHETIC AND MUSCLE RELAXANT) ENTITLED "INTRAOCULAR PRESSURE IN ELECTROCONVULSIVE THERAPY" DOI: 10.1001/ARCHOPHT.1963.00960050464006 "INVESTIGATIONS MADE HITHERTO INDICATE THAT A TEMPORARY RISE IN THE INTRAOCULAR PRESSURE OCCURS DURING ELECTROCONVULSIVE THERAPY (ECT). THUS MEASUREMENTS MADE DURING THE CONVULSIVE PHASE, WHICH ARE RARE SINCE THEY ASSUME A SATISFACTORY DEGREE OF MUSCULAR RELAXATION, HAVE SHOWN AN INCREASE IN TENSION. IMMEDIATELY AFTER THE BEGINNING OF THE SEIZURE THERE IS A MARKED RISE IN TENSION, WHICH DECLINES SLOWLY AS THE SEIZURE PROCEEDS AND DURING THE POST-SEIZURE PERIOD. IF TENSION EXCEEDING 30 MM IS REGARDED AS PATHOLOGICAL, THE TENSION IS ABOVE NORMAL FOR RATHER MORE THAN ONE MINUTE. THE MEAN VALUE IS HIGHEST AT TIME TEN AND THE TENSION HAS THEN A VARIATION RANGE OF 25 TO 68 MM. COMPARED WITH THE VALUE IMMEDIATELY PRIOR TO THE SHOCK, THE DIFFERENCE IN TENSION IS SIGNIFICANT AT THE 0.001 LEVEL UP TO TIME 60..." WHAT ARE THE LONG-TERM PATHOLOGICAL IMPLICATIONS OF REPEATED SPIKING OF INTRAOCULAR PRESSURE TO SUCH SERIOUS LEVELS? WHAT IS THE RATE OF POSTERIOR VITREOUS DETACHMENT, CATARACTS, AND OTHER SMALL VESICLE ISCHEMIC OCULAR DISEASES IN PEOPLE WITH A HISTORY OF ECT? WITHOUT DOSING CONSENSUS STANDARDS FOR THE MORE THAN 1,000 POSSIBLE ELECTRICAL FIELD STRENGTH DOSES POSSIBLE ON THIS DEVICE, IT IS IMPOSSIBLE FOR A CONSCIENTIOUS PHYSICIAN TO KNOW HOW TO REDUCE THE LIKELIHOOD OF CAUSING PERMANENT OR DELAYED INJURY TO OUR PATIENTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
946795 THYMATRON ELECTROCONVULSIVE THERAPY DEVICE FOR CATATONIA, MAJOR DEPRESSIVE DISORDER, AND B QGH SOMATICS, LLC.

Patients

Seq Age Sex Outcome Treatment
1 NA Female Disability| O