MAUDE Adverse Event Report: UNKNOWN ECT DEVICE, THYMATRON SYSTEM IV; ELECTROCONVULSIVE THERAPY DEVICE FOR CATATONIA, MAJOR DEPRESSIVE DISORDER, AND B

Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Apnea (1720); Fall (1848); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Tachycardia (2095); Visual Impairment (2138); Ambulation Difficulties (2544); Cognitive Changes (2551); Confusion/ Disorientation (2553); Convulsion/Seizure (4406); Speech Disorder (4415); Eye Pain (4467); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 01/01/2006

Event Type  Injury  

Event Description

Patient (pts) began receiving ect for misdiagnosed mental illness at age (b)(6).Ect began in 2001 and ending around 2006.Estimated total number of treatments: 60-90.Documented device used from second ect doctor: thymatron system iv.Treatment time frame in this device: 2004 - 2006.Prior machine used for first ect doctor is unknown.Pts began losing memories and mental capacity at start, losing phone numbers, locker combinations, past memories.Patient hasn't regained memorization and retention ability.Became worse to point pts no longer felt connected to her past memories, identity, relationships.Ect side affected cognition, memory, daily activities, speech, vision, nervous system, social functioning, education and employment potential.During last ect suffered disabling symptoms resembling progressive neurodegenerative disease similar to electrical injury/tbi.Pts unable to finish college/secure/work.Pts lives on ssdi and government insurance.Significant working memory deficit, trouble forming new memories, trouble retaining information, using memory for basic tasks adls: pts get confused doing basic tasks, requires accessibility aids to manage.She still needs help from family and friends.Social functioning pts can no longer follow/process conversations effectively nor manage timing.Struggles to retain information in working memory and will often talk too fast before forgets.Can only process one sense at a time.She has to switch between hearing, speaking, listening.Is fatiguing/limits how often she can interact with others.2016: signs of progressive decline.She began falling-legs involuntarily turning inward involuntarily or knees giving.When attacks are severe she falls/ requires help getting up.Pts has a delayed response to pain.Example: hand touched hot metal and she paused several seconds before realizing she was being burned.2016 patient began showing signs of seizures; muscles will stiffen and contract involuntarily.Speech probs began after ect.Word finding probs often lead to long tangents.When a patient is fatigued she may stutter or go mute.When patient is exposed to high heat like spa becomes confused struggles to speak, has a hard time with cold temps, urinary retention, suggesting brain stem dysfunction.Vision patient has struggled with vision and visual processing following ect.Eyes no longer work together leading to strain, headaches and mental fatigue.One eye will droop when fatigued.Sensory processing (spd) prior to ect.All spd worsened.Pts needs ear plugs.May collapse when startled visually or auditorily.Dysregulated more easily.Vision processing has been impaired - eyes no longer work together causing strain and headaches.Patient has become sensitive to light/needs to wear blue blockers/sunglasses indoors.Sleep developed central sleep apnea while receiving ect.It is resolved but during seizure episodes sometimes stops breathing while lungs are still taking in air suggesting a type of apnea.Still struggles with insomnia.Suspected acquired channelopathies (voltage gated ion channels) unusual reactions to certain foods, meds and otc resembling acquired channelopathies.Pts was given lidocaine boosted ect around the same time she developed reactions where tachycardia happened.No such prior reactions also causes possible seizures.One instance caused a kind of paralysis where pts unable to speak to stop excruciating pain while aware it was happening.Dying tooth, drilled, damaging the trigem.Nerve.Some other triggering substances: certain sodium drugs, caffeine, calcium, calcium blockers etc.Certain types of sodium meds, allegra = tetany seizures.Formal diagnosis of symptoms wisc and 5-day psychological testing: working memory deficit 0.1 , slow processing speed, chronic encephalopathy-pts monitored annually.Impaired executive function anterior grade amnesia.Fda safety report id# (b)(4).

• Brand Name: UNKNOWN ECT DEVICE, THYMATRON SYSTEM IV
• Type of Device: ELECTROCONVULSIVE THERAPY DEVICE FOR CATATONIA, MAJOR DEPRESSIVE DISORDER, AND B
• MDR Report Key: 13059666
• MDR Text Key: 282718026
• Report Number: MW5106185
• Device Sequence Number: 2
• Product Code: QGH
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/16/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Hospitalization; Life Threatening
• Patient Sex: Female