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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
2018 325 325
2019 258 258
2020 177 177
2021 188 188
2022 185 185
2023 52 52

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 312 312
Insufficient Information 226 226
Inappropriate/Inadequate Shock/Stimulation 198 198
Migration or Expulsion of Device 138 138
Battery Problem 95 95
High impedance 85 85
Electromagnetic Compatibility Problem 68 68
Device Operates Differently Than Expected 65 65
Break 61 61
Premature Discharge of Battery 50 50
Energy Output Problem 50 50
Impedance Problem 48 48
Unstable 46 46
Failure to Deliver Energy 39 39
Patient Device Interaction Problem 39 39
Electromagnetic Interference 25 25
Malposition of Device 22 22
Intermittent Continuity 20 20
Unintended Collision 20 20
Entrapment of Device 18 18
Material Deformation 18 18
Positioning Problem 16 16
Low Battery 16 16
Overheating of Device 15 15
Therapy Delivered to Incorrect Body Area 12 12
Pocket Stimulation 11 11
Communication or Transmission Problem 11 11
Connection Problem 10 10
Failure to Interrogate 10 10
Disconnection 10 10
Environmental Compatibility Problem 7 7
Appropriate Term/Code Not Available 7 7
Human-Device Interface Problem 6 6
Degraded 6 6
Low impedance 5 5
Device Displays Incorrect Message 5 5
Noise, Audible 4 4
Shipping Damage or Problem 4 4
Vibration 3 3
Improper or Incorrect Procedure or Method 3 3
Unexpected Therapeutic Results 3 3
Data Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Device Dislodged or Dislocated 3 3
Difficult to Remove 2 2
Peeled/Delaminated 2 2
Device Or Device Fragments Location Unknown 2 2
Display or Visual Feedback Problem 2 2
No Device Output 1 1
Corroded 1 1
Material Erosion 1 1
Grounding Malfunction 1 1
Electro-Static Discharge 1 1
Patient-Device Incompatibility 1 1
Ambient Noise Problem 1 1
Detachment of Device or Device Component 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 228 228
No Known Impact Or Consequence To Patient 197 197
Electric Shock 196 196
Vomiting 184 184
Nausea 166 166
No Clinical Signs, Symptoms or Conditions 151 151
Insufficient Information 124 124
Complaint, Ill-Defined 117 117
Therapeutic Response, Decreased 99 99
Therapeutic Effects, Unexpected 97 97
Unspecified Infection 84 84
Abdominal Pain 60 60
Malaise 57 57
Paresis 54 54
Discomfort 52 52
Erosion 37 37
Weight Changes 31 31
Burning Sensation 25 25
Internal Organ Perforation 23 23
Undesired Nerve Stimulation 21 21
Seroma 20 20
No Code Available 20 20
Constipation 19 19
Pocket Erosion 18 18
Diarrhea 14 14
Obstruction/Occlusion 14 14
Swelling 13 13
Foreign Body In Patient 13 13
Abdominal Distention 12 12
Scar Tissue 12 12
Muscle Spasm(s) 12 12
Sepsis 10 10
Fever 10 10
Bacterial Infection 9 9
Swelling/ Edema 9 9
Cramp(s) /Muscle Spasm(s) 9 9
Hernia 9 9
Twitching 8 8
Wound Dehiscence 8 8
Erythema 8 8
Dehydration 7 7
Sleep Dysfunction 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Fluid Discharge 6 6
Device Embedded In Tissue or Plaque 6 6
Ambulation Difficulties 6 6
Dysphagia/ Odynophagia 6 6
Hemorrhage/Bleeding 6 6
Inflammation 5 5
Headache 5 5
Foreign Body Reaction 5 5
Abscess 5 5
Bruise/Contusion 5 5
Staphylococcus Aureus 5 5
Hematoma 5 5
Cognitive Changes 5 5
Loss of consciousness 5 5
Impaired Healing 5 5
Anxiety 5 5
Shaking/Tremors 4 4
Failure of Implant 4 4
Rash 4 4
Urinary Tract Infection 4 4
Adhesion(s) 4 4
Dyspnea 4 4
Eructate 4 4
Purulent Discharge 3 3
Cellulitis 3 3
Irritation 3 3
Hypersensitivity/Allergic reaction 3 3
Hypoglycemia 3 3
Device Overstimulation of Tissue 3 3
Pneumonia 3 3
Tissue Breakdown 3 3
Test Result 3 3
Twiddlers Syndrome 3 3
Ulcer 3 3
Urinary Frequency 3 3
Injury 3 3
Abdominal Cramps 3 3
Post Operative Wound Infection 3 3
Distress 2 2
Cramp(s) 2 2
Viral Infection 2 2
Shock from Patient Lead(s) 2 2
Cancer 2 2
Incontinence 2 2
Twiddlers Syndrome 2 2
Urinary Retention 2 2
Pulmonary Edema 2 2
Seizures 2 2
Low Blood Pressure/ Hypotension 2 2
Hyperglycemia 2 2
Pyrosis/Heartburn 2 2
Chest Pain 2 2
Death 1 1
Calcium Deposits/Calcification 1 1
Edema 1 1
Emotional Changes 1 1
Feeding Problem 1 1

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