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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, electroconvulsive therapy
Regulation Description Electroconvulsive therapy device.
Product CodeGXC
Regulation Number 882.5940
Device Class 3

MDR Year MDR Reports MDR Events
2020 28 28
2021 18 18
2022 25 25
2023 7 7
2024 7 7
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 46 46
Patient-Device Incompatibility 10 10
No Apparent Adverse Event 8 8
Inadequate Instructions for Non-Healthcare Professional 3 3
Insufficient Information 2 2
Sparking 1 1
Break 1 1
Output Problem 1 1
Smoking 1 1
Therapeutic or Diagnostic Output Failure 1 1
Inadequate Instructions for Healthcare Professional 1 1
Patient Device Interaction Problem 1 1
Detachment of Device or Device Component 1 1
Unexpected Therapeutic Results 1 1
Improper or Incorrect Procedure or Method 1 1
Unintended Collision 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Memory Loss/Impairment 41 41
Cognitive Changes 26 26
Brain Injury 13 13
Emotional Changes 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Depression 7 7
Headache 6 6
Confusion/ Disorientation 6 6
Injury 6 6
Pain 5 5
Suicidal Ideation 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Unspecified Mental, Emotional or Behavioural Problem 4 4
Sleep Dysfunction 3 3
Insufficient Information 3 3
No Code Available 3 3
Shaking/Tremors 3 3
Increased Sensitivity 2 2
Dysphasia 2 2
Distress 2 2
Status Epilepticus 2 2
Visual Impairment 2 2
Seizures 2 2
Irritability 2 2
Disability 2 2
Fecal Incontinence 2 2
Nerve Damage 2 2
Convulsion/Seizure 2 2
Chest Pain 2 2
Anxiety 2 2
Laceration(s) 1 1
Coma 1 1
Lactate Dehydrogenase Increased 1 1
Bradycardia 1 1
Asystole 1 1
Tachycardia 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Myocardial Infarction 1 1
Therapeutic Response, Decreased 1 1
Cardiac Enzyme Elevation 1 1
Therapeutic Effects, Unexpected 1 1
Loss of consciousness 1 1
Heart Block 1 1
Hormonal Imbalance 1 1
Sensitivity of Teeth 1 1
Increased Sensitivity 1 1
ST Segment Depression 1 1
Aspiration Pneumonitis 1 1
Hair Loss 1 1

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