FDA Adverse Event Injury Summary report: N

ECT DEVICE THYMATRON SYSTEM IV (SOMATICS)

MDR report key: 15192774 · Received August 8, 2022

Report

Report Number
MW5111350
Event Type
Injury
Date Received
August 8, 2022
Date of Event
August 15, 2018
Report Date
August 4, 2022
Manufacturer
SOMATICS, LLC.
Product Code
QGH
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CH
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

IN AN EFFORT TO CLOSE THE GAP BETWEEN REAL WORLD OUTCOMES AND THOSE ACKNOWLEDGED BY THE FDA, DEVICE MANUFACTURERS, HOSPITALS AND DOCTORS, THIS REPORT IS SUBMITTED AS MY DUTY AS A MANDATED REPORTER, DRAWING DATA FROM PUBLISHED A CASE REPORT (DOI: 10.3389/FPSYT.2022.899847) A CASE REPORT OF LEUKOCYTOSIS DURING MODIFIED ELECTROCONVULSIVE THERAPY OF PARANOID PERSONALITY DISORDER. FRONT. PSYCHIATRY 13:899847. ON (B)(6) 2018, BEFORE THE PATIENT RECEIVED MECT FOR THE FIRST TIME, WE CONDUCTED REGULAR LABORATORY EXAMINATION DURING HOSPITALIZATION, WHICH SHOWED THAT THE PATIENT'S BLOOD CELL COUNT, LIVER FUNCTION AND RENAL FUNCTION WERE NORMAL. BEFORE MECT, WE ONCE AGAIN MONITORED THE VITAL SIGNS OF THE PATIENT, BODY TEMPERATURE: 36.3 DEGREES CELSIUS, PULSE: 78 TIMES/MIN, BLOOD PRESSURE: 110/66 MMHG, USED THYMATRON, THE INTERNAL OUTPUT VOLTAGE IS 450 V AND THE OUTPUT CURRENT IS 900 MA. WHEN STARTING THE TREATMENT, THE ENERGIZING ENERGY WAS 20% J, BECAUSE OF UNSTABLE CURRENT DURING THE TREATMENT PROCESS, THE INSTRUMENT AUTOMATICALLY ADJUSTED THE CURRENT TO 920 MA, AND THE ENERGIZING TIME WAS 5.6 S. DURING AND AFTER MECT, THE PATIENT HAD VERY SLIGHT AND UNSUSTAINABLE LIMB VIBRATION LASTED NEARLY 10 MIN, WITH NO OTHER SYMPTOMS. VITAL SIGNS REMAINED STABLE, WHICH WAS RELIEVED AFTER SEVERAL MINUTES, AND SHE WAS ESCORTED BACK TO THE WARD BY GUARDIANS AND DOCTORS. HOWEVER, AFTER RETURNING TO THE WARD, THE PATIENT DEVELOPED A FEVER, WITH A MAXIMUM TEMPERATURE OF 38.2 DEGREES CELSIUS. AFTER WE GAVE A SHORT PHYSICAL COOLING, THE PATIENT'S TEMPERATURE RETURNED TO NORMAL, BUT THE DOCTOR ON DUTY DID NOT ARRANGE THE RELEVANT LABORATORY EXAMINATION ON THAT DAY. THE REASON FOR THE PATIENT'S LIMB VIBRATION AND FEVER AFTER MECT ON THE FIRST DAY LACKED EVIDENCE. ON (B)(6) 2018, WE ARRANGED A SECOND MODIFIED ELECTROTHERAPY FOR THE PATIENT. WE SELECTED THE SAME MECT PARAMETERS AS THE FIRST TIME, ... BUT AFTER RETURNING TO THE WARD, WE FOUND THAT THE PATIENT'S TEMPERATURE GRADUALLY INCREASED, UP TO 39.3 DEGREES CELSIUS, ACCOMPANIED BY SLIGHT LIMB VIBRATION LASTED NEARLY 20 MIN. THE EXAMINATION RESULTS SHOWED THAT THE LEUKOCYTE COUNT OF THE PATIENT WAS 26.40×109/L, THE ABSOLUTE VALUE OF NEUTROPHILS WAS 23.87×109/L, THE ABSOLUTE VALUE OF MONOCYTES WAS 1.29×109/L, AND INFLAMMATION-RELATED FACTORS (PROCALCITONIN, C-REACTIVE PROTEIN, INTERLEUKIN-6),LIVER AND KIDNEY FUNCTION, AEROBIC AND ANAEROBIC BLOOD CULTURE, URINATION ROUTINE AND COAGULATION FUNCTION WERE NORMAL. WE ALSO ARRANGED EMERGENCY CHEST COMPUTED TOMOGRAPHY (CT) AND EEG EXAMS TO RULE OUT THE POSSIBILITY OF PULMONARY INFECTION AND EPILEPSY, AND ALL THE RESULTS WERE NORMAL. HEMATOLOGY DEPARTMENT RECOMMENDED HYDRATION TREATMENT TO REDUCE THE WHITE BLOOD CELL COUNT, HEMATOLOGY DEPARTMENT CANNOT GIVE A SPECIFIC EXPLANATION FOR THE SUDDEN INCREASE IN WHITE BLOOD CELLS. THE PATIENT WAS FOLLOWED UP IN THE CLINIC, BUT THE TREATMENT EFFECT WAS NOT IDEAL. SLIGHT AND TRANSIENT LIMB VIBRATION OCCURRED DURING AND AFTER MECT, AND FEVER AND LEUKOCYTOSIS WERE FOUND AFTER MECT. WE RULED OUT THE POSSIBILITY OF INFECTION AND EPILEPSY AND USED INTRAVENOUS REHYDRATION TO RESTORE THE NUMBER OF LEUKOCYTES TO NORMAL, AND THE RESULTS SHOWED THAT IT WAS EFFECTIVE. THIS CASE SUGGESTS THAT WHILE ADVOCATING RESIDUAL TREATMENT APPROACHES IN PATIENTS WITH PPD, WE SHOULD BE VIGILANT AGAINST THE OCCURRENCE OF LEUKOCYTOSIS BEFORE, DURING AND AFTER MECT, AS WELL AS OTHER UNREPORTED CONDITIONS. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1606682 ECT DEVICE THYMATRON SYSTEM IV (SOMATICS) ELECTROCONVULSIVE THERAPY DEVICE FOR CATATONIA, MAJOR DEPRESSIVE DISORDER, AND B QGH SOMATICS, LLC. THYMATRON SYSTEM IV

Patients

Seq Age Sex Outcome Treatment
1 24 YR Female Other| H