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 Code	QGH
Regulation Number	882.5940
Device Class	2

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	12	12
Cognitive Changes	12	12
Brain Injury	8	8
Suicidal Ideation	6	6
Headache	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Depression	4	4
High Blood Pressure/ Hypertension	4	4
Pain	4	4
Tachycardia	3	3
Fatigue	3	3
Emotional Changes	3	3
Anxiety	3	3
Confusion/ Disorientation	2	2
Diminished Pulse Pressure	2	2
Superficial (First Degree) Burn	2	2
Increased Sensitivity	2	2
Unspecified Mental, Emotional or Behavioural Problem	2	2
Convulsion/Seizure	2	2
Speech Disorder	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Fall	2	2
Bradycardia	2	2
Arrhythmia	2	2
Stroke/CVA	2	2
Chest Pain	2	2
Tinnitus	2	2
Ischemia	2	2
Dizziness	2	2
Low Blood Pressure/ Hypotension	2	2
Nausea	2	2
Nerve Damage	1	1
Neuropathy	1	1
Muscle Weakness	1	1
Myocardial Infarction	1	1
Incontinence	1	1
Inflammation	1	1
Pneumonia	1	1
Visual Impairment	1	1
Loss of Vision	1	1
Visual Disturbances	1	1
Twitching	1	1
Dyspnea	1	1
Non specific EKG/ECG Changes	1	1
Asthma	1	1
Pulmonary Embolism	1	1
Apnea	1	1
Cardiac Arrest	1	1
Fever	1	1
Bone Fracture(s)	1	1
Hypersensitivity/Allergic reaction	1	1
Unspecified Musculoskeletal problem	1	1
Thrombosis/Thrombus	1	1
Heart Failure/Congestive Heart Failure	1	1
Eye Pain	1	1
Unspecified Tissue Injury	1	1
Decreased Appetite	1	1
Fecal Incontinence	1	1
Balance Problems	1	1
Discomfort	1	1
Arthralgia	1	1
Myalgia	1	1
Joint Dislocation	1	1
Numbness	1	1
Coma	1	1
Neck Pain	1	1
Vitreous Detachment	1	1
Low Oxygen Saturation	1	1
Shaking/Tremors	1	1
Sleep Dysfunction	1	1
Ambulation Difficulties	1	1