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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
2018 15 15
2019 16 16
2020 28 28
2021 18 18
2022 25 25
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 62 62
Patient-Device Incompatibility 17 17
No Apparent Adverse Event 8 8
Insufficient Information 5 5
Inadequate Instructions for Non-Healthcare Professional 3 3
Device Operational Issue 2 2
Therapeutic or Diagnostic Output Failure 2 2
Patient Device Interaction Problem 1 1
Output Problem 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Break 1 1
Inadequate Instructions for Healthcare Professional 1 1
Unintended Collision 1 1
Smoking 1 1
Unexpected Therapeutic Results 1 1
Sparking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Memory Loss/Impairment 57 57
Cognitive Changes 30 30
Depression 22 22
Brain Injury 16 16
Emotional Changes 9 9
Confusion/ Disorientation 8 8
Injury 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Headache 5 5
Pain 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Suicidal Ideation 4 4
Sleep Dysfunction 4 4
No Code Available 4 4
Disability 3 3
Insufficient Information 3 3
Distress 3 3
Nausea 3 3
Anxiety 2 2
Dizziness 2 2
Dysphasia 2 2
Seizures 2 2
Visual Impairment 2 2
Bone Fracture(s) 2 2
Death 2 2
Shaking/Tremors 2 2
Convulsion/Seizure 2 2
Status Epilepticus 2 2
Hemorrhagic Stroke 1 1
Diminished Pulse Pressure 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
Inadequate Pain Relief 1 1
Coma 1 1
Loss of consciousness 1 1
Irritability 1 1
Obstruction/Occlusion 1 1
Sensitivity of Teeth 1 1
Neck Pain 1 1
Sweating 1 1
High Pulmonary Arterial Wedge Pressure 1 1
ST Segment Depression 1 1
Ambulation Difficulties 1 1
Asystole 1 1
Aspiration Pneumonitis 1 1
Increased Sensitivity 1 1
Unspecified Tissue Injury 1 1
Alteration in Body Temperature 1 1
Dyspnea 1 1
Syncope 1 1
Abdominal Pain 1 1
Hair Loss 1 1
Cardiac Enzyme Elevation 1 1
Erythema 1 1
Paralysis 1 1
Rash 1 1
Respiratory Distress 1 1
Retinal Detachment 1 1
Scarring 1 1
Hearing Impairment 1 1
Laceration(s) 1 1
Myocardial Infarction 1 1
Loss of Vision 1 1
Visual Disturbances 1 1
Vomiting 1 1
Increased Sensitivity 1 1
Skin Irritation 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1
Blurred Vision 1 1
Hernia 1 1
Therapeutic Response, Decreased 1 1

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