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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
2019 258 258
2020 177 177
2021 188 188
2022 185 185
2023 165 165
2024 102 102

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 281 281
Insufficient Information 235 235
Inappropriate/Inadequate Shock/Stimulation 170 170
Migration or Expulsion of Device 109 109
Battery Problem 90 90
High impedance 69 69
Break 54 54
Electromagnetic Compatibility Problem 52 52
Patient Device Interaction Problem 45 45
Premature Discharge of Battery 44 44
Impedance Problem 43 43
Unstable 33 33
Energy Output Problem 32 32
Failure to Deliver Energy 25 25
Electromagnetic Interference 20 20
Appropriate Term/Code Not Available 20 20
Malposition of Device 17 17
Entrapment of Device 14 14
Unintended Collision 14 14
Intermittent Continuity 12 12
Positioning Problem 12 12
Communication or Transmission Problem 11 11
Failure to Interrogate 11 11
Material Deformation 11 11
Overheating of Device 10 10
Disconnection 9 9
Pocket Stimulation 9 9
Connection Problem 8 8
Therapy Delivered to Incorrect Body Area 6 6
Environmental Compatibility Problem 6 6
Degraded 5 5
Migration 5 5
Human-Device Interface Problem 5 5
Patient-Device Incompatibility 4 4
Improper or Incorrect Procedure or Method 4 4
Intermittent Shock/Stimulation 4 4
Unintended Electrical Shock 4 4
Data Problem 3 3
Device Dislodged or Dislocated 3 3
Vibration 3 3
Material Puncture/Hole 3 3
Material Erosion 3 3
Material Perforation 2 2
Use of Device Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Low impedance 2 2
Unintended Movement 2 2
Unexpected Therapeutic Results 2 2
Display or Visual Feedback Problem 2 2
Loose or Intermittent Connection 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 195 195
Pain 181 181
Electric Shock 178 178
Insufficient Information 154 154
Vomiting 129 129
Nausea 127 127
No Known Impact Or Consequence To Patient 113 113
Unspecified Infection 89 89
Complaint, Ill-Defined 58 58
Therapeutic Response, Decreased 56 56
Therapeutic Effects, Unexpected 48 48
Discomfort 47 47
Abdominal Pain 42 42
Failure of Implant 39 39
Paresis 31 31
Malaise 29 29
Erosion 26 26
Weight Changes 22 22
Internal Organ Perforation 21 21
Pocket Erosion 20 20
Burning Sensation 20 20
Seroma 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Undesired Nerve Stimulation 13 13
Constipation 11 11
Muscle Spasm(s) 10 10
Erythema 10 10
Abdominal Distention 10 10
Sepsis 10 10
Cramp(s) /Muscle Spasm(s) 9 9
Swelling/ Edema 9 9
Obstruction/Occlusion 8 8
Scar Tissue 8 8
Swelling 8 8
Diarrhea 8 8
Foreign Body In Patient 8 8
Bacterial Infection 7 7
Device Embedded In Tissue or Plaque 6 6
Implant Pain 6 6
Wound Dehiscence 6 6
Fluid Discharge 6 6
Dehydration 6 6
Twitching 6 6
Fever 6 6
Skin Infection 5 5
Hypersensitivity/Allergic reaction 5 5
Anxiety 5 5
Foreign Body Reaction 5 5
No Code Available 5 5
Hernia 5 5

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