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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 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Deflation Problem 849 849
Insufficient Information 744 744
Unintended Deflation 215 215
Fluid/Blood Leak 210 210
Patient-Device Incompatibility 181 181
Air/Gas in Device 159 159
Adverse Event Without Identified Device or Use Problem 156 156
Inflation Problem 150 150
Device Slipped 145 145
Use of Device Problem 122 122
Migration or Expulsion of Device 93 93
Migration 86 86
Patient Device Interaction Problem 38 38
Detachment of Device or Device Component 28 28
Leak/Splash 27 27
Material Separation 26 26
Difficult to Remove 17 17
Appropriate Term/Code Not Available 13 13
Disconnection 12 12
Obstruction of Flow 12 12
Break 11 11
Mechanical Problem 11 11
Unintended Movement 9 9
No Apparent Adverse Event 8 8
Infusion or Flow Problem 8 8
Improper or Incorrect Procedure or Method 7 7
Fracture 7 7
Output Problem 7 7
Material Integrity Problem 5 5
Material Split, Cut or Torn 5 5
Burst Container or Vessel 5 5
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Device Dislodged or Dislocated 4 4
Material Too Rigid or Stiff 4 4
Difficult to Advance 4 4
Material Twisted/Bent 4 4
Compatibility Problem 3 3
Premature Separation 3 3
Defective Device 3 4
Partial Blockage 3 3
Expulsion 2 2
Biofilm coating in Device 2 2
Failure to Deflate 2 2
Human-Device Interface Problem 2 2
Inadequate or Insufficient Training 2 2
Unexpected Therapeutic Results 2 2
Failure to Advance 2 2
Increase in Pressure 2 2
Separation Problem 2 2
Inadequacy of Device Shape and/or Size 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 662 662
Insufficient Information 616 616
Vomiting 440 441
Abdominal Pain 323 324
Failure of Implant 308 308
Nausea 144 144
Erosion 128 128
Pain 125 126
Discomfort 80 80
Pyrosis/Heartburn 75 75
Dysphagia/ Odynophagia 55 55
Obstruction/Occlusion 47 47
Hernia 44 44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 41 41
Dehydration 35 35
Perforation 27 27
Unspecified Infection 23 23
Ulcer 22 22
Hemorrhage/Bleeding 18 18
Scar Tissue 18 18
Gastrointestinal Regurgitation 17 17
Weight Changes 16 16
Foreign Body In Patient 16 16
Perforation of Esophagus 15 15
Stomach Ulceration 13 13
Abdominal Distention 13 13
Sepsis 12 12
Diarrhea 12 12
Pancreatitis 11 11
Device Embedded In Tissue or Plaque 10 10
Constipation 10 10
Hair Loss 10 10
Gastritis 10 10
Inflammation 10 10
Laceration(s) 9 9
Unspecified Gastrointestinal Problem 9 9
Fever 9 9
Anemia 9 9
Bacterial Infection 8 8
Unspecified Tissue Injury 7 7
Adhesion(s) 7 7
Fatigue 7 8
Choking 6 6
Implant Pain 6 6
Swelling/ Edema 6 6
Cough 6 6
Hypersensitivity/Allergic reaction 5 5
Aspiration Pneumonitis 5 5
Pneumonia 5 5
Aspiration/Inhalation 5 5

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