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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 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 265 265
Insufficient Information 211 211
Inappropriate/Inadequate Shock/Stimulation 167 167
Migration or Expulsion of Device 109 109
Battery Problem 89 89
High impedance 66 66
Break 54 54
Electromagnetic Compatibility Problem 52 52
Patient Device Interaction Problem 45 45
Premature Discharge of Battery 43 43
Impedance Problem 42 42
Unstable 33 33
Energy Output Problem 32 32
Failure to Deliver Energy 25 25
Electromagnetic Interference 20 20
Malposition of Device 17 17
Unintended Collision 14 14
Entrapment of Device 14 14
Intermittent Continuity 12 12
Positioning Problem 12 12
Material Deformation 11 11
Communication or Transmission Problem 11 11
Failure to Interrogate 11 11
Overheating of Device 10 10
Pocket Stimulation 9 9
Disconnection 9 9
Appropriate Term/Code Not Available 9 9
Connection Problem 8 8
Environmental Compatibility Problem 6 6
Therapy Delivered to Incorrect Body Area 6 6
Degraded 5 5
Human-Device Interface Problem 5 5
Intermittent Shock/Stimulation 4 4
Unintended Electrical Shock 4 4
Improper or Incorrect Procedure or Method 4 4
Material Puncture/Hole 3 3
Vibration 3 3
Data Problem 3 3
Patient-Device Incompatibility 3 3
Device Dislodged or Dislocated 3 3
Device Contamination with Chemical or Other Material 2 2
Unintended Movement 2 2
Noise, Audible 2 2
Material Perforation 2 2
Low impedance 2 2
Use of Device Problem 2 2
Unexpected Therapeutic Results 2 2
Display or Visual Feedback Problem 2 2
Material Erosion 2 2
Corroded 1 1
Loose or Intermittent Connection 1 1
Misassembled 1 1
No Device Output 1 1
Difficult to Remove 1 1
Shipping Damage or Problem 1 1
Defibrillation/Stimulation Problem 1 1
Device Difficult to Program or Calibrate 1 1
Peeled/Delaminated 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Migration 1 1
Device Fell 1 1
Therapeutic or Diagnostic Output Failure 1 1
Battery Problem: Low Impedance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 181 181
No Clinical Signs, Symptoms or Conditions 181 181
Electric Shock 169 169
Insufficient Information 150 150
Vomiting 129 129
Nausea 126 126
No Known Impact Or Consequence To Patient 113 113
Unspecified Infection 83 83
Complaint, Ill-Defined 58 58
Therapeutic Response, Decreased 56 56
Therapeutic Effects, Unexpected 48 48
Discomfort 46 46
Abdominal Pain 42 42
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
Undesired Nerve Stimulation 13 13
Constipation 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Abdominal Distention 10 10
Sepsis 10 10
Erythema 10 10
Muscle Spasm(s) 10 10
Swelling/ Edema 9 9
Cramp(s) /Muscle Spasm(s) 9 9
Foreign Body In Patient 8 8
Obstruction/Occlusion 8 8
Diarrhea 8 8
Swelling 8 8
Scar Tissue 8 8
Bacterial Infection 7 7
Wound Dehiscence 6 6
Dehydration 6 6
Fever 6 6
Twitching 6 6
Fluid Discharge 6 6
Device Embedded In Tissue or Plaque 6 6
No Code Available 5 5
Skin Infection 5 5
Hernia 5 5
Anxiety 5 5
Foreign Body Reaction 5 5
Hypersensitivity/Allergic reaction 5 5
Hematoma 4 4
Inflammation 4 4
Failure of Implant 4 4
Adhesion(s) 4 4
Bruise/Contusion 4 4
Implant Pain 4 4
Post Operative Wound Infection 4 4
Shaking/Tremors 4 4
Sleep Dysfunction 4 4
Ambulation Difficulties 4 4
Impaired Healing 4 4
Loss of consciousness 3 3
Abdominal Cramps 3 3
Twiddlers Syndrome 3 3
Cellulitis 3 3
Incontinence 3 3
Hemorrhage/Bleeding 3 3
Ulcer 3 3
Urinary Frequency 3 3
Staphylococcus Aureus 3 3
Shock 3 3
Rash 2 2
Headache 2 2
Device Overstimulation of Tissue 2 2
Distress 2 2
Hypoglycemia 2 2
Muscle Weakness 2 2
Necrosis 2 2
Abscess 2 2
Eructate 2 2
Purulent Discharge 2 2
Unspecified Gastrointestinal Problem 2 2
External Prosthetic Device Pain 2 2
Injury 2 2
Cancer 2 2
Bowel Perforation 2 2
Tissue Breakdown 1 1
Lethargy 1 1
Fibrosis 1 1
Convulsion/Seizure 1 1
Neuralgia 1 1
Paresthesia 1 1
Suicidal Ideation 1 1
Depression 1 1
Irritability 1 1
Numbness 1 1
Coma 1 1
Cognitive Changes 1 1
Confusion/ Disorientation 1 1
Post Traumatic Wound Infection 1 1
Diaphoresis 1 1
Prolapse 1 1

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