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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, anti-gastroesophageal reflux
Product CodeLEI
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 75 75

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1006 1006
Device Appears to Trigger Rejection 526 526
Patient Device Interaction Problem 314 314
Detachment of Device or Device Component 175 175
Migration or Expulsion of Device 146 146
Appropriate Term/Code Not Available 111 111
Insufficient Information 63 63
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
Contamination /Decontamination Problem 1 1
Device Dislodged or Dislocated 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Device Damaged by Another Device 1 1
Scratched Material 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Fluid/Blood Leak 1 1
Hole In Material 1 1
Delivered as Unsterile Product 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Slipped 1 1
Obstruction of Flow 1 1
High Test Results 1 1
Structural Problem 1 1
Defective Device 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Dysphagia/ Odynophagia 1019 1019
No Code Available 460 460
Pyrosis/Heartburn 410 410
Pain 186 186
Insufficient Information 181 181
Vomiting 157 157
Hernia 111 111
Nausea 70 70
Erosion 69 69
Pocket Erosion 65 65
Abdominal Pain 59 59
Chest Pain 47 47
Abdominal Distention 38 38
Cramp(s) /Muscle Spasm(s) 37 37
Weight Changes 35 35
Inflammation 30 30
No Consequences Or Impact To Patient 25 25
No Information 23 23
No Known Impact Or Consequence To Patient 19 19
Paresis 17 17
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
Pneumonia 7 7
Scar Tissue 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Unspecified Infection 5 5
Fatigue 5 5
Flatus 5 5
Headache 5 5
Dehydration 5 5
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
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
Hypoxia 1 1
Itching Sensation 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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