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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
2019 16 25
2020 28 29
2021 18 18
2022 25 25
2023 7 7
2024 6 6
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 60 70
Patient-Device Incompatibility 11 11
No Apparent Adverse Event 8 8
Inadequate Instructions for Non-Healthcare Professional 3 3
Insufficient Information 3 3
Therapeutic or Diagnostic Output Failure 2 2
Patient Device Interaction Problem 2 2
Sparking 1 1
Break 1 1
Output Problem 1 1
Smoking 1 1
Inadequate Instructions for Healthcare Professional 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 56 57
Cognitive Changes 35 36
Brain Injury 16 16
Depression 12 12
Emotional Changes 10 11
Confusion/ Disorientation 8 9
Suicidal Ideation 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Injury 7 7
Sleep Dysfunction 6 6
Unspecified Mental, Emotional or Behavioural Problem 5 5
Anxiety 5 5
Headache 5 5
Pain 4 4
No Code Available 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Insufficient Information 3 3
Shaking/Tremors 3 3
Disability 3 3
Visual Impairment 2 2
Nerve Damage 2 2
Convulsion/Seizure 2 2
Bone Fracture(s) 2 2
Irritability 2 2
Seizures 2 3
Status Epilepticus 2 2
Distress 2 2
Dysphasia 2 2
Increased Sensitivity 2 2
Inadequate Pain Relief 1 9
Therapeutic Effects, Unexpected 1 1
Loss of consciousness 1 2
Cardiac Enzyme Elevation 1 1
Heart Block 1 1
Therapeutic Response, Decreased 1 1
Hormonal Imbalance 1 1
Myocardial Infarction 1 1
Swelling/ Edema 1 1
Unspecified Tissue Injury 1 1
Sensitivity of Teeth 1 1
Tachycardia 1 1
Increased Sensitivity 1 1
Asystole 1 1
Bradycardia 1 1
Lactate Dehydrogenase Increased 1 1
Coma 1 1
ST Segment Depression 1 1
Ambulation Difficulties 1 1
Aspiration Pneumonitis 1 1
Laceration(s) 1 1

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