ELECTROCONVULSIVE THERAPY DEVICE THYMATRON SYSTEM IV

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for ELECTROCONVULSIVE THERAPY DEVICE THYMATRON SYSTEM IV manufactured by Somatics, Llc.

Event Text Entries

[185187892] On (b)(6) 2010 immediately after dental procedure requiring local anesthetic, pt experienced what the dentist believed was a seizure, hemiplegia, respiratory distress, altered consciousness, dry heaving, and dizziness. Pt taken to local hosp by ambulance for a ct scan. No stroke on scan. Pt transferred to second hosp for add'l assessments. No evidence of tia. Pt kept over night for observation due to hemiparesis. Symptoms resolved overnight. Pt discharged following morning. In 2017 after administration of lidocaine for a medical procedure requiring local anesthetic. Pt experienced what medical staff thought was a seizure, hemiplegia, respiratory distress, altered consciousness, dry heaving, dizziness and partial syncope. Pt kept under observation until symptoms resolved. In 2018 after administration of lidocaine for a medical procedure requiring local anesthetic, pt experienced what medical staff thought was a seizure, hemiplegia, respiratory distress, altered consciousness, dry heaving, dizziness and partial syncope. Pt kept under observation until symptoms resolved. Prior to ect, pt had no history of adverse events when exposed to lidocaine or other amino amines. Pt has no history of familial channelopathies. However, in 2009, pt quit ect against medical advice after more than 100 bilateral shock treatments did not alleviate symptomology. Highly likely that pt developed decreased threshold for lidocaine (and amino amine) seizures and other for channel dysfunction as direct result of repeated electroconvulsive shock. Channelopathies now causing a host of paroxysmal neurological cardiac, pulmonary sequelae associated with delayed low-voltage electrical injury including dystonia, ataxia, dysarthria, dysphagia, diaphragmatic paralysis, and arrhythmia. Electroshock likely permanently alters voltage-gated on channels. Imagine what that means for life after ect: acute sensitivity to any voltage-gated ion in the air (chlorine, ethyl mercaptan (smell put into gas acts on sodium channels). I pass out / go ataxic / have every single symptom that i have with lidocaine with environmental exposure to anything acting on sodium ion channels. Episodic ataxia is related to potassium channelopathies, paroxysmal movement disorders are associated with channelopathies which also explains my episodic chorea, dystonia, ataxia, paroxysmal dyskinesia, muscle weakness, fatigue, etc. No one discusses risks of delayed electrical injury or its associated pathologies. Its time we tell pts that we have no idea how repeatedly exposing them to 800-900ma/240-450 volts/504-576mc electricity using a machine that never underwent pre-market approval safety testing and consequently has zero standardized operating procedures will impact life. Supporting evidence: chen, r. , li, y. -j. , li, j. -q. , lv, x-x. , chen, s. -z. , li, w. -z. , li, x-y. (2011). Electrical injury alters ion channel expression levels and electrophysiological properties in rabbit dorsal root ganglia neurons. Burns, 37(2), 304-311. Doi:10. 1016/j. Burns. 2010. 08. 006; chen, w. , zhongsheng, z. , & lee, r. C. (2006). Supramembrane potential-induced electroconformational changes in sodium channel proteins. A potential mechanism involved in electric injury. Burns, 32(1), 52-59. Doi:10. 1016/j. Burns. 2005. 08. 008; erro, r. , bhatia, k. P. , espay, a. J. , & striano, p. (2017). The epileptic and nonepileptic spectrum of paroxysmal dyskinesias: channelopathies, synaptopathies, and transportopathies. Movement disorders, 32(3), 310-318 https://doi. Org/10. 1002/mds. 26901; kragh, j. , bolwig, t. G. , woldbye, d. P. D. , & jorgensen, o. S. (1993). Electroconvulsive shock and lidocaine-induced seizures in the rat activate astrocytes as measured by glial fibrillary acidic protein. Biological psychiatry, 33(11-12), 794-800. Https://doi. Org/10. 1016/0006-3223(93)900 5. Berg, j. S. , & morse, m. S. (2004). A shocking neurological rarity. Practical neurology 4, 222-227. Without standard operating procedures for administration technique outcome dichotomy is too vast to provide pts with reliable outcomes. Sackeim h. A. , prudic, j. , fuller, r. , keilp, j. , lavori, p. W. , & olfson, m. (2007). The cognitive effects of electroconvulsive therapy in community settings. Neuropsychopharmacology: official publication of the american college of neuropsychopharmacology. 32(1), 244-254. Https://doi. Org/10. 1038/sj. Npp. 1301180 neuropathology studies on electrical injury are clear. Long term consequences of ect's repetitive low-voltage electrical injury must be considered through the lens of both a repetitive electrical injury and a repetitive head injury. Gallagher, j. P. , & talbert, o. R. (1991). Motor neuron syndrome after electric shock. Acta neurologica scandinavica, 83(2), 79-82. Https://doi. Org/10. 1111/j. 1600-0404. 1991. Tb04653. X lee, r. C. (2011). Injury by electrical forces: pathophysiology, manifestations, and therapy. Current problems in ptca, 34(9), 680-764. Https://doi. Org/10. 1007/978-3-642-72407-7 morse, m. S. , berg, j. S. , & ten wolde, r. L. (2004). Diffuse electrical injury: a study of 89 subjects reporting long-term symptomatology that is remote to the theoretical current pathway. Ieee transactions on biomedical engineering, 51(8), 1449-1459. Https://doi. Org/10. 1109/tbme. 2004. 827343 morse, m. S. , berg, j. S. , & ten wolde, r. L. (2003). Diffuse electrical injury - a study of 136 subjects. Annual international conference of the ieee engineering in medicine and biology - proceedings, 2 (march), 1694-1697. Https://doi. Org/10. 1109/iembs. 2003. 1279716 singerman, j. , gomez, m. , & fish, j. S. (2008). Long-term sequelae of low-voltage electrical injury. Journal of burn care and research. Https://doi. Org/10. 1097/bcr. 0b013e318184815d wesner, m. L. , & hickie, j. (2013). Long-term sequelae of electrical injury. (b)(6) family physician, 59(september), 935-939. Repetitive electrical injury to the head creates pts who are "outside the scope of practice" for most neurologists. Local brain injury programs have specialists with no experience with electricity as a "mechanism of injury". Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093911
MDR Report Key9877701
Date Received2020-03-24
Date of Report2020-03-20
Date of Event2010-07-26
Date Added to Maude2020-03-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameELECTROCONVULSIVE THERAPY DEVICE THYMATRON SYSTEM IV
Generic NameDEVICE, ELECTROCONVULSIVE THERAPY
Product CodeGXC
Date Received2020-03-24
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSOMATICS, LLC

Device Sequence Number: 2

Brand NameMECTA SR2
Generic NameDEVICE, ELECTROCONVULSIVE THERAPY
Product CodeGXC
Date Received2020-03-24
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerMECTA CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Deathisabilit 2020-03-24

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