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TPLC
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show TPLC since
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Device
valve, pulmonary
Definition
To improve lung function in patients with emphysema
Product Code
NJK
Device Class
3
Premarket Approvals (PMA)
2018
2019
2020
2021
2022
2023
4
14
5
2
2
1
MDR Year
MDR Reports
MDR Events
2018
14
14
2019
215
215
2020
344
344
2021
405
405
2022
342
342
2023
93
93
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1295
1295
Material Split, Cut or Torn
71
71
Insufficient Information
44
44
Non Reproducible Results
4
4
Appropriate Term/Code Not Available
3
3
Unexpected Therapeutic Results
3
3
Detachment of Device or Device Component
3
3
Use of Device Problem
2
2
Defective Component
2
2
Device Contamination with Body Fluid
1
1
Activation, Positioning or Separation Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Gas/Air Leak
1
1
Mechanical Jam
1
1
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Migration
1
1
No Tactile Prompts/Feedback
1
1
Positioning Failure
1
1
Off-Label Use
1
1
Difficult to Remove
1
1
Separation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pneumothorax
1207
1207
Pneumonia
62
62
No Clinical Signs, Symptoms or Conditions
56
56
Respiratory Failure
49
49
Death
33
33
Cardiac Arrest
25
25
Pleural Effusion
24
24
No Known Impact Or Consequence To Patient
21
21
Respiratory Tract Infection
17
17
Atrial Fibrillation
13
13
Dyspnea
11
11
Sepsis
10
10
Insufficient Information
9
9
Pulmonary Emphysema
8
8
Pulmonary Edema
7
7
Renal Failure
7
7
Low Oxygen Saturation
7
7
Hemoptysis
6
6
Hypoxia
6
6
Adult Respiratory Distress Syndrome
6
6
Abscess
5
5
Patient Problem/Medical Problem
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Respiratory Insufficiency
4
4
Fungal Infection
4
4
Obstruction/Occlusion
4
4
Septic Shock
4
4
Shock
4
4
Unspecified Infection
4
4
Myocardial Infarction
4
4
Ischemic Heart Disease
3
3
Ventilator Dependent
3
3
Anemia
3
3
Cardiopulmonary Arrest
3
3
Bradycardia
3
3
Cyst(s)
3
3
Hemorrhage/Bleeding
3
3
Low Blood Pressure/ Hypotension
3
3
Wheezing
3
3
Unspecified Respiratory Problem
3
3
Bronchospasm
3
3
Constipation
3
3
Unspecified Heart Problem
3
3
Cough
2
2
Foreign Body In Patient
2
2
Chest Pain
2
2
Low Cardiac Output
2
2
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Viral Infection
1
1
Bacterial Infection
1
1
Pulmonary Embolism
1
1
Failure of Implant
1
1
Drug Resistant Bacterial Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Olympus Corporation of the Americas
II
Feb-01-2022
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