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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, intragastric for morbid obesity
Product CodeLTI
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
3 2 4 4 2 2

MDR Year MDR Reports MDR Events
2021 193 194
2022 609 609
2023 975 975
2024 451 451
2025 300 300
2026 104 104

Device Problems MDRs with this Device Problem Events in those MDRs
Deflation Problem 866 866
Insufficient Device Problem Information 739 739
Fluid/Blood Leak 211 211
Unintended Deflation 205 205
Patient-Device Incompatibility 178 178
Air/Gas in Device 165 165
Adverse Event Without Identified Device or Use Problem 159 159
Inflation Problem 154 154
Device Slipped 144 144
Use of Device Problem 130 130
Migration or Expulsion of Device 98 98
Migration 84 84
Patient Device Interaction Problem 50 50
Detachment of Device or Device Component 29 29
Material Separation 24 24
Difficult to Remove 19 19
Leak/Splash 18 18
Material Split, Cut or Torn 13 13
Appropriate Device Problem Term/Code Not Available 12 12
Obstruction of Flow 12 12
Mechanical Problem 11 11
Disconnection 10 10
Break 10 10
Unintended Movement 9 9
Infusion or Flow Problem 8 8
No Apparent Adverse Event 8 8
Improper or Incorrect Procedure or Method 6 6
Material Integrity Problem 5 5
Burst Container or Vessel 5 5
Fracture 5 5
Difficult to Advance 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Material Twisted/Bent 4 4
Premature Separation 3 3
Microbial Contamination of Device 3 3
Material Too Rigid or Stiff 3 3
Partial Blockage 3 3
Device Dislodged or Dislocated 3 3
Failure to Advance 3 3
Compatibility Problem 3 3
Defective Component 2 2
Defective Device 2 2
Deformation Due to Compressive Stress 2 2
Contamination 2 2
Complete Blockage 2 2
Failure to Deflate 2 2
Separation Problem 2 2
Misassembled 2 2
Human-Device Interface Problem 2 2
Inadequate or Insufficient Training 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 699 699
Insufficient Information 616 616
Vomiting 454 455
Abdominal Pain 336 337
Failure of Implant 308 308
Nausea 152 152
Erosion 128 128
Pain 128 129
Discomfort 84 84
Heartburn/Indigestion 76 76
Dysphagia/ Odynophagia 55 55
Obstruction/Occlusion 52 52
Hernia 44 44
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 43 43
Dehydration 39 39
Perforation 27 27
Unspecified Infection 24 24
Ulcer 22 22
Hemorrhage/Blood Loss/Bleeding 18 18
Scar Tissue 18 18
Gastrointestinal Regurgitation 17 17
Foreign Body In Patient 16 16
Weight Changes 16 16
Perforation of Esophagus 15 15
Abdominal Distention 14 14
Stomach Ulceration 13 13
Diarrhea 12 12
Pancreatitis 12 12
Sepsis 12 12
Inflammation 12 12
Constipation 11 11
Gastritis 10 10
Hair Loss 10 10
Laceration(s) 10 10
Unspecified Gastrointestinal Problem 10 10
Device Embedded In Tissue or Plaque 10 10
Unspecified Tissue Injury 9 9
Anemia 9 9
Fever 9 9
Bacterial Infection 8 8
Adhesion(s) 7 7
Fatigue 7 8
Aspiration/Inhalation 6 6
Choking 6 6
Pneumonia 6 6
Cough 6 6
Implant Pain 6 6
Swelling/ Edema 6 6
Hypersensitivity/Allergic reaction 5 5
Syncope/Fainting 5 5

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