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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electroconvulsive therapy device for catatonia, major depressive disorder, and bipolar disorder
Regulation Description Electroconvulsive therapy device.
Definition Catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.
Product CodeQGH
Regulation Number 882.5940
Device Class 2


Premarket Reviews
ManufacturerDecision
MECTA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 16 16
2023 8 8
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Unexpected Therapeutic Results 4 4
Patient-Device Incompatibility 2 2
No Apparent Adverse Event 2 2
Use of Device Problem 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Memory Loss/Impairment 13 13
Cognitive Changes 12 12
Brain Injury 9 9
Suicidal Ideation 6 6
Headache 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Depression 5 5
Pain 4 4
High Blood Pressure/ Hypertension 4 4
Superficial (First Degree) Burn 3 3
Stroke/CVA 3 3
Tachycardia 3 3
Anxiety 3 3
Confusion/ Disorientation 3 3
Fatigue 3 3
Convulsion/Seizure 3 3
Emotional Changes 3 3
Ischemia 3 3
Fall 2 2
Chest Pain 2 2
Bradycardia 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Diminished Pulse Pressure 2 2
Tinnitus 2 2
Dizziness 2 2
Nausea 2 2
Low Blood Pressure/ Hypotension 2 2
Arrhythmia 2 2
Speech Disorder 2 2
Increased Sensitivity 2 2
Unspecified Heart Problem 1 1
Eye Pain 1 1
Myocardial Infarction 1 1
Unspecified Tissue Injury 1 1
Loss of Vision 1 1
Shaking/Tremors 1 1
Low Oxygen Saturation 1 1
Heart Failure/Congestive Heart Failure 1 1
Pneumonia 1 1
Dementia 1 1
Coma 1 1
Ambulation Difficulties 1 1
Dyspnea 1 1
Balance Problems 1 1
Visual Impairment 1 1
Pulmonary Embolism 1 1
Decreased Appetite 1 1
Discomfort 1 1
Twitching 1 1

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