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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
Product CodeGXC
Regulation Number 882.5940
Device Class 3

MDR Year MDR Reports MDR Events
2014 1 1
2015 2 2
2016 6 6
2017 2 2
2018 15 15
2019 16 16
2020 28 28
2021 18 18
2022 25 25
2023 7 7
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 67 67
Patient-Device Incompatibility 19 19
No Apparent Adverse Event 8 8
Insufficient Information 7 7
Inadequate Instructions for Non-Healthcare Professional 3 3
Therapeutic or Diagnostic Output Failure 2 2
Device Operates Differently Than Expected 2 2
Device Operational Issue 2 2
Sparking 1 1
Smoking 1 1
Detachment of Device or Device Component 1 1
Human-Device Interface Problem 1 1
Unexpected Therapeutic Results 1 1
Improper or Incorrect Procedure or Method 1 1
Unintended Collision 1 1
Detachment Of Device Component 1 1
Break 1 1
Output Problem 1 1
Patient Device Interaction Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Memory Loss/Impairment 66 66
Cognitive Changes 35 35
Depression 25 25
Brain Injury 17 17
Emotional Changes 13 13
Confusion/ Disorientation 11 11
Headache 10 10
Injury 9 9
Pain 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Sleep Dysfunction 5 5
Nausea 5 5
No Code Available 5 5
Shaking/Tremors 4 4
Anxiety 4 4
Suicidal Ideation 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Disability 4 4
Distress 3 3
Insufficient Information 3 3
Seizures 3 3
Dizziness 3 3
Increased Sensitivity 2 2
Status Epilepticus 2 2
Loss of Vision 2 2
Convulsion/Seizure 2 2
Visual Impairment 2 2
Vomiting 2 2
Retinal Detachment 2 2
Nerve Damage 2 2
Chest Pain 2 2
Dysphasia 2 2
Bone Fracture(s) 2 2
Fecal Incontinence 2 2
No Information 2 2
Death 2 2
Abdominal Pain 1 1
Aspiration Pneumonitis 1 1
Ambulation Difficulties 1 1
ST Segment Depression 1 1
Hearing Impairment 1 1
Increased Sensitivity 1 1
High Blood Pressure/ Hypertension 1 1
Sensitivity of Teeth 1 1
Heart Block 1 1
Irritability 1 1
Loss of consciousness 1 1
Inadequate Pain Relief 1 1
Therapeutic Effects, Unexpected 1 1
Hemorrhage/Bleeding 1 1

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