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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
2020 177 177
2021 188 188
2022 185 185
2023 165 165
2024 160 160
2025 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 261 261
Insufficient Information 230 230
Inappropriate/Inadequate Shock/Stimulation 131 131
Migration or Expulsion of Device 87 87
Battery Problem 69 69
High impedance 62 62
Break 44 44
Premature Discharge of Battery 38 38
Electromagnetic Compatibility Problem 37 37
Patient Device Interaction Problem 31 31
Impedance Problem 29 29
Unstable 22 22
Appropriate Term/Code Not Available 18 18
Failure to Deliver Energy 17 17
Energy Output Problem 17 17
Malposition of Device 14 14
Electromagnetic Interference 14 14
Entrapment of Device 13 13
Migration 12 12
Intermittent Continuity 10 10
Material Deformation 10 10
Communication or Transmission Problem 9 9
Failure to Interrogate 9 9
Positioning Problem 9 9
Pocket Stimulation 8 8
Connection Problem 8 8
Disconnection 7 7
Therapy Delivered to Incorrect Body Area 5 5
Overheating of Device 5 5
No Apparent Adverse Event 4 4
Environmental Compatibility Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Intermittent Shock/Stimulation 4 4
Patient-Device Incompatibility 4 4
Unintended Collision 4 4
Unintended Electrical Shock 4 4
Vibration 3 3
Data Problem 3 3
Material Puncture/Hole 3 3
Device Dislodged or Dislocated 3 3
Unexpected Therapeutic Results 2 2
Human-Device Interface Problem 2 2
Display or Visual Feedback Problem 2 2
Loose or Intermittent Connection 2 2
Low impedance 2 2
Device Contamination with Chemical or Other Material 2 2
Material Perforation 2 2
Use of Device Problem 2 2
Degraded 2 2
Unintended Movement 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 204 204
Electric Shock 165 165
Insufficient Information 154 154
Pain 141 141
Failure of Implant 98 98
Vomiting 93 93
Nausea 92 92
Unspecified Infection 80 80
No Known Impact Or Consequence To Patient 39 39
Discomfort 36 36
Abdominal Pain 30 30
Therapeutic Response, Decreased 26 26
Complaint, Ill-Defined 21 21
Therapeutic Effects, Unexpected 20 20
Erosion 20 20
Weight Changes 19 19
Malaise 19 19
Pocket Erosion 17 17
Internal Organ Perforation 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Paresis 13 13
Undesired Nerve Stimulation 12 12
Seroma 11 11
Burning Sensation 10 10
Swelling/ Edema 9 9
Obstruction/Occlusion 9 9
Cramp(s) /Muscle Spasm(s) 9 9
Erythema 8 8
Scar Tissue 7 7
Sepsis 7 7
Abdominal Distention 7 7
Implant Pain 6 6
Constipation 6 6
Muscle Spasm(s) 6 6
Diarrhea 6 6
Foreign Body In Patient 6 6
Device Embedded In Tissue or Plaque 6 6
Fluid Discharge 5 5
Hypersensitivity/Allergic reaction 5 5
Foreign Body Reaction 5 5
Skin Infection 5 5
Anxiety 4 4
Shaking/Tremors 4 4
Dehydration 4 4
Twitching 4 4
Swelling 4 4
Fever 4 4
Impaired Healing 4 4
Post Operative Wound Infection 4 4
Wound Dehiscence 4 4

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