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TPLC
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show TPLC since
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Device
implant, anti-gastroesophageal reflux
Product Code
LEI
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
0
0
0
3
5
3
4
4
1
6
2
1
0
6
2
1
MDR Year
MDR Reports
MDR Events
2014
42
42
2015
57
57
2016
92
92
2017
133
133
2018
202
202
2019
280
280
2020
193
193
2021
263
263
2022
250
250
2023
246
246
2024
49
49
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
993
993
Device Appears to Trigger Rejection
514
514
Patient Device Interaction Problem
305
305
Detachment of Device or Device Component
168
168
Migration or Expulsion of Device
143
143
Appropriate Term/Code Not Available
111
111
Insufficient Information
62
62
Therapeutic or Diagnostic Output Failure
42
42
Unexpected Therapeutic Results
21
21
Material Erosion
18
18
Patient-Device Incompatibility
17
17
Nonstandard Device
13
13
Device-Device Incompatibility
12
12
Defective Component
9
9
Material Separation
8
8
Break
7
7
Use of Device Problem
6
6
Improper or Incorrect Procedure or Method
4
4
Disconnection
4
4
Malposition of Device
4
4
Protective Measures Problem
3
3
Migration
3
3
Device Operates Differently Than Expected
2
2
Mechanical Problem
2
2
Defective Device
1
1
Device Slipped
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Fluid/Blood Leak
1
1
Scratched Material
1
1
Device Damaged by Another Device
1
1
Hole In Material
1
1
Unintended Movement
1
1
Inadequacy of Device Shape and/or Size
1
1
Physical Resistance/Sticking
1
1
Material Deformation
1
1
Difficult to Remove
1
1
Material Integrity Problem
1
1
Device Dislodged or Dislocated
1
1
No Apparent Adverse Event
1
1
Structural Problem
1
1
Obstruction of Flow
1
1
High Test Results
1
1
Contamination /Decontamination Problem
1
1
Delivered as Unsterile Product
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Dysphagia/ Odynophagia
1007
1007
No Code Available
460
460
Pyrosis/Heartburn
404
404
Pain
184
184
Insufficient Information
175
175
Vomiting
154
154
Hernia
107
107
Erosion
69
69
Nausea
68
68
Pocket Erosion
63
63
Abdominal Pain
59
59
Chest Pain
47
47
Abdominal Distention
38
38
Cramp(s) /Muscle Spasm(s)
34
34
Weight Changes
33
33
Inflammation
28
28
No Consequences Or Impact To Patient
25
25
No Information
23
23
No Known Impact Or Consequence To Patient
19
19
Paresis
16
16
Foreign Body In Patient
13
13
Anxiety
12
12
Muscle Spasm(s)
11
11
Not Applicable
10
10
Choking
9
9
Discomfort
9
9
Regurgitation
8
8
Failure of Implant
8
8
Adhesion(s)
8
8
Obstruction/Occlusion
8
8
No Clinical Signs, Symptoms or Conditions
7
7
Diarrhea
7
7
High Blood Pressure/ Hypertension
7
7
Complaint, Ill-Defined
7
7
Burning Sensation
7
7
Scar Tissue
7
7
Pneumonia
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Fatigue
5
5
Flatus
5
5
Headache
5
5
Dehydration
4
4
Hypersensitivity/Allergic reaction
4
4
Abscess
4
4
Autoimmune Disorder
4
4
Speech Disorder
4
4
Perforation of Esophagus
4
4
Blood Loss
3
3
Syncope/Fainting
3
3
Unspecified Tissue Injury
3
3
Unspecified Infection
3
3
Dyspnea
3
3
Hemorrhage/Bleeding
3
3
Pneumothorax
3
3
Sepsis
3
3
Ulcer
3
3
Depression
2
2
Swelling
2
2
Urinary Retention
2
2
Dizziness
2
2
Necrosis
2
2
Nerve Damage
2
2
Neurological Deficit/Dysfunction
2
2
Breast Cancer
2
2
Cardiac Arrest
2
2
Apnea
2
2
Arrhythmia
2
2
Aspiration/Inhalation
2
2
Asthma
2
2
Swelling/ Edema
2
2
Patient Problem/Medical Problem
2
2
Respiratory Failure
2
2
Bowel Perforation
2
2
Electric Shock
1
1
Numbness
1
1
Neck Pain
1
1
Alteration in Body Temperature
1
1
Decreased Appetite
1
1
Paresthesia
1
1
Pericarditis
1
1
Mitral Valve Insufficiency/ Regurgitation
1
1
Unspecified Respiratory Problem
1
1
Arthritis
1
1
Adult Respiratory Distress Syndrome
1
1
Death
1
1
Autoimmune Reaction
1
1
Bacterial Infection
1
1
Bruise/Contusion
1
1
Eructate
1
1
Pulmonary Embolism
1
1
Itching Sensation
1
1
Hypoxia
1
1
Neuropathy
1
1
Internal Organ Perforation
1
1
Muscle Weakness
1
1
Muscular Rigidity
1
1
Myocardial Infarction
1
1
Pleural Effusion
1
1
Scarring
1
1
Scleroderma
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Torax Medical, Inc.
II
May-31-2018
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