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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
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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10 10
Unexpected Therapeutic Results 4 4
Use of Device Problem 1 1
Patient-Device Incompatibility 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cognitive Changes 8 8
Memory Loss/Impairment 7 7
Headache 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Suicidal Ideation 3 3
High Blood Pressure/ Hypertension 3 3
Tachycardia 3 3
Tinnitus 2 2
Dizziness 2 2
Brain Injury 2 2
Depression 2 2
Fatigue 2 2
Bradycardia 2 2
Diminished Pulse Pressure 2 2
Convulsion/Seizure 2 2
Speech Disorder 2 2
Increased Sensitivity 2 2
Unspecified Tissue Injury 1 1
Superficial (First Degree) Burn 1 1
Balance Problems 1 1
Confusion/ Disorientation 1 1
Thrombosis/Thrombus 1 1
Eye Pain 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Cardiac Arrest 1 1
Stroke/CVA 1 1
Chest Pain 1 1
Dyspnea 1 1
Non specific EKG/ECG Changes 1 1
Emotional Changes 1 1
Fall 1 1
Fever 1 1
Pulmonary Embolism 1 1
Apnea 1 1
Arrhythmia 1 1
Low Blood Pressure/ Hypotension 1 1
Incontinence 1 1
Inflammation 1 1
Ischemia 1 1
Numbness 1 1
Neck Pain 1 1
Low Oxygen Saturation 1 1
Shaking/Tremors 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 1 1
Anxiety 1 1
Arthralgia 1 1
Visual Impairment 1 1
Loss of Vision 1 1
Twitching 1 1
Muscle Weakness 1 1
Nausea 1 1
Nerve Damage 1 1
Neuropathy 1 1
Pain 1 1

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