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TPLC
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show TPLC since
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Device
device, electroconvulsive therapy
Product Code
GXC
Regulation Number
882.5940
Device Class
3
MDR Year
MDR Reports
MDR Events
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
59
59
Patient-Device Incompatibility
11
11
No Apparent Adverse Event
8
8
Insufficient Information
3
3
Inadequate Instructions for Non-Healthcare Professional
3
3
Therapeutic or Diagnostic Output Failure
2
2
Patient Device Interaction Problem
1
1
Detachment of Device or Device Component
1
1
Output Problem
1
1
Break
1
1
Inadequate Instructions for Healthcare Professional
1
1
Unintended Collision
1
1
Smoking
1
1
Unexpected Therapeutic Results
1
1
Improper or Incorrect Procedure or Method
1
1
Sparking
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Memory Loss/Impairment
51
51
Cognitive Changes
29
29
Brain Injury
16
16
Depression
9
9
Emotional Changes
8
8
Injury
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Confusion/ Disorientation
6
6
Headache
5
5
Pain
5
5
No Code Available
4
4
Suicidal Ideation
4
4
No Clinical Signs, Symptoms or Conditions
4
4
Insufficient Information
3
3
Shaking/Tremors
3
3
Sleep Dysfunction
3
3
Disability
3
3
Anxiety
2
2
Distress
2
2
Fecal Incontinence
2
2
Increased Sensitivity
2
2
Convulsion/Seizure
2
2
Status Epilepticus
2
2
Seizures
2
2
Nerve Damage
2
2
Dysphasia
2
2
Visual Impairment
2
2
Chest Pain
2
2
Bone Fracture(s)
2
2
Hair Loss
1
1
Dyspnea
1
1
Hearing Impairment
1
1
High Blood Pressure/ Hypertension
1
1
Ischemia
1
1
Laceration(s)
1
1
Cardiac Enzyme Elevation
1
1
Erythema
1
1
Fatigue
1
1
Syncope
1
1
Abdominal Pain
1
1
Atrial Fibrillation
1
1
Bradycardia
1
1
Visual Disturbances
1
1
Vomiting
1
1
Dizziness
1
1
Myocardial Infarction
1
1
Nausea
1
1
Increased Sensitivity
1
1
Skin Irritation
1
1
Tachycardia
1
1
Therapeutic Effects, Unexpected
1
1
Paralysis
1
1
Rash
1
1
Respiratory Distress
1
1
Scarring
1
1
Movement Disorder
1
1
Hemorrhagic Stroke
1
1
Asystole
1
1
Heart Block
1
1
Aspiration Pneumonitis
1
1
Unspecified Tissue Injury
1
1
Lactate Dehydrogenase Increased
1
1
Alteration in Body Temperature
1
1
Ambulation Difficulties
1
1
Hernia
1
1
Therapeutic Response, Decreased
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
ST Segment Depression
1
1
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