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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intestinal stimulator
Product CodeLNQ
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2021 188 188
2022 185 185
2023 165 165
2024 160 160
2025 182 182

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 267 267
Adverse Event Without Identified Device or Use Problem 233 233
Inappropriate/Inadequate Shock/Stimulation 101 101
Migration or Expulsion of Device 65 65
High impedance 52 52
Battery Problem 52 52
Break 45 45
Electromagnetic Compatibility Problem 30 30
Impedance Problem 28 28
Premature Discharge of Battery 27 27
Patient Device Interaction Problem 24 24
Unstable 19 19
Appropriate Term/Code Not Available 18 18
Malposition of Device 16 16
Energy Output Problem 13 13
Migration 13 13
Failure to Deliver Energy 12 12
Electromagnetic Interference 10 10
Unintended Electrical Shock 10 10
No Apparent Adverse Event 10 10
Entrapment of Device 9 9
Intermittent Continuity 9 9
Material Deformation 8 8
Positioning Problem 8 8
Connection Problem 7 7
Pocket Stimulation 7 7
Disconnection 6 6
Communication or Transmission Problem 6 6
Failure to Interrogate 6 6
Lack of Effect 5 5
Therapy Delivered to Incorrect Body Area 4 4
Intermittent Shock/Stimulation 4 4
Improper or Incorrect Procedure or Method 4 4
Patient-Device Incompatibility 4 4
Unintended Collision 3 3
Loose or Intermittent Connection 3 3
Overheating of Device 3 3
Device Dislodged or Dislocated 3 3
Material Puncture/Hole 3 3
Data Problem 3 3
Environmental Compatibility Problem 3 3
Vibration 3 3
Unintended Movement 2 2
Device Contamination with Chemical or Other Material 2 2
Low impedance 2 2
Material Erosion 2 2
Human-Device Interface Problem 2 2
Material Perforation 2 2
Material Twisted/Bent 2 2
Use of Device Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 201 201
Electric Shock 159 159
Insufficient Information 159 159
Failure of Implant 138 138
Pain 98 98
Nausea 80 80
Unspecified Infection 74 74
Vomiting 73 73
Abdominal Pain 29 29
Discomfort 24 24
Erosion 18 18
Implant Pain 17 17
Pocket Erosion 16 16
Internal Organ Perforation 14 14
Malaise 14 14
Weight Changes 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Unspecified Gastrointestinal Problem 10 10
Undesired Nerve Stimulation 9 9
Paresis 9 9
Seroma 9 9
Diarrhea 8 8
Cramp(s) /Muscle Spasm(s) 8 8
Obstruction/Occlusion 8 8
Swelling/ Edema 7 7
Scar Tissue 7 7
Erythema 7 7
Burning Sensation 7 7
Sepsis 6 6
Skin Infection 5 5
Constipation 5 5
Fluid Discharge 5 5
Abdominal Distention 4 4
Shaking/Tremors 4 4
Device Embedded In Tissue or Plaque 3 3
Hematoma 3 3
Foreign Body Reaction 3 3
Impaired Healing 3 3
Post Operative Wound Infection 3 3
Hemorrhage/Bleeding 3 3
Adhesion(s) 3 3
Shock 3 3
Hypersensitivity/Allergic reaction 3 3
Twiddlers Syndrome 3 3
Dehydration 3 3
External Prosthetic Device Pain 2 2
Ambulation Difficulties 2 2
Distress 2 2
Bruise/Contusion 2 2
Urinary Frequency 2 2

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