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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 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 266 266
Insufficient Information 217 217
Inappropriate/Inadequate Shock/Stimulation 170 170
Migration or Expulsion of Device 109 109
Battery Problem 90 90
High impedance 66 66
Break 54 54
Electromagnetic Compatibility Problem 52 52
Patient Device Interaction Problem 45 45
Impedance Problem 43 43
Premature Discharge of Battery 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
Unintended Collision 14 14
Entrapment of Device 14 14
Intermittent Continuity 12 12
Positioning Problem 12 12
Communication or Transmission Problem 11 11
Material Deformation 11 11
Failure to Interrogate 11 11
Overheating of Device 10 10
Pocket Stimulation 9 9
Disconnection 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
Patient-Device Incompatibility 4 4
Improper or Incorrect Procedure or Method 4 4
Unintended Electrical Shock 4 4
Migration 3 3
Data Problem 3 3
Device Dislodged or Dislocated 3 3
Material Erosion 3 3
Material Puncture/Hole 3 3
Vibration 3 3
Use of Device Problem 2 2
Unexpected Therapeutic Results 2 2
Display or Visual Feedback Problem 2 2
Material Perforation 2 2
Low impedance 2 2
Device Contamination with Chemical or Other Material 2 2
Noise, Audible 2 2
Unintended Movement 2 2
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Device Fell 1 1
Therapeutic or Diagnostic Output Failure 1 1
Battery Problem: Low Impedance 1 1
Biocompatibility 1 1
Corroded 1 1
Failure to Deliver Shock/Stimulation 1 1
Loose or Intermittent Connection 1 1
Misassembled 1 1
Device Difficult to Program or Calibrate 1 1
Device Appears to Trigger Rejection 1 1
Difficult to Remove 1 1
Shipping Damage or Problem 1 1
Defibrillation/Stimulation Problem 1 1
Peeled/Delaminated 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 184 184
Pain 181 181
Electric Shock 173 173
Insufficient Information 153 153
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 47 47
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
Failure of Implant 18 18
Seroma 17 17
Undesired Nerve Stimulation 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Constipation 11 11
Abdominal Distention 10 10
Sepsis 10 10
Muscle Spasm(s) 10 10
Erythema 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
Implant Pain 6 6
Skin Infection 5 5
No Code Available 5 5
Hernia 5 5
Anxiety 5 5
Foreign Body Reaction 5 5
Hypersensitivity/Allergic reaction 5 5
Hematoma 4 4
Inflammation 4 4
Adhesion(s) 4 4
Bruise/Contusion 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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