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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
2014 413 413
2015 300 300
2016 377 377
2017 438 438
2018 325 325
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 753 753
Device Operates Differently Than Expected 554 554
Inappropriate/Inadequate Shock/Stimulation 424 424
Migration or Expulsion of Device 261 261
Insufficient Information 257 257
High impedance 197 197
Electromagnetic Compatibility Problem 158 158
Break 147 147
Battery Problem 133 133
Premature Discharge of Battery 107 107
Failure to Deliver Energy 99 99
Unstable 93 93
Low Battery 89 89
Impedance Problem 87 87
Electromagnetic Interference 70 70
Unintended Collision 70 70
Malposition of Device 64 64
Patient Device Interaction Problem 59 59
Energy Output Problem 54 54
Pocket Stimulation 44 44
Communication or Transmission Problem 41 41
Intermittent Continuity 40 40
Overheating of Device 39 39
Material Deformation 37 37
Failure to Interrogate 34 34
Positioning Problem 32 32
Therapy Delivered to Incorrect Body Area 29 29
Entrapment of Device 26 26
Device Or Device Fragments Location Unknown 26 26
Disconnection 25 25
Device Displays Incorrect Message 20 20
Low impedance 15 15
Connection Problem 15 15
Environmental Compatibility Problem 13 13
Human-Device Interface Problem 13 13
Appropriate Term/Code Not Available 13 13
Device Contamination with Chemical or Other Material 11 11
Shipping Damage or Problem 11 11
Degraded 10 10
Shelf Life Exceeded 10 10
Unexpected Therapeutic Results 9 9
Material Erosion 7 7
Energy Output To Patient Tissue Incorrect 7 7
Vibration 6 6
Noise, Audible 6 6
Electro-Static Discharge 5 5
Device Dislodged or Dislocated 5 5
Display or Visual Feedback Problem 5 5
No Device Output 5 5
Improper or Incorrect Procedure or Method 4 4
Intermittent Shock/Stimulation 4 4
Patient-Device Incompatibility 4 4
Unintended Electrical Shock 4 4
Data Problem 4 4
Ambient Noise Problem 3 3
Loss of Data 3 3
Material Twisted/Bent 3 3
Device Difficult to Program or Calibrate 3 3
Material Puncture/Hole 3 3
Unable to Obtain Readings 3 3
Difficult to Remove 3 3
Peeled/Delaminated 2 2
Improper Device Output 2 2
Compatibility Problem 2 2
Material Perforation 2 2
Device Inoperable 2 2
Use of Device Problem 2 2
Unintended Movement 2 2
Therapeutic or Diagnostic Output Failure 1 1
Unauthorized Access to Computer System 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Migration 1 1
Device Fell 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Battery Problem: Low Impedance 1 1
Output Problem 1 1
Detachment of Device or Device Component 1 1
Misassembled 1 1
Nonstandard Device 1 1
Defibrillation/Stimulation Problem 1 1
Failure to Read Input Signal 1 1
Inadequacy of Device Shape and/or Size 1 1
Corroded 1 1
Bent 1 1
Computer Software Problem 1 1
Loose or Intermittent Connection 1 1
Grounding Malfunction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 508 508
Pain 477 477
Vomiting 468 468
Nausea 443 443
Electric Shock 417 417
Complaint, Ill-Defined 401 401
Therapeutic Response, Decreased 391 391
Therapeutic Effects, Unexpected 323 323
No Clinical Signs, Symptoms or Conditions 183 183
Abdominal Pain 178 178
Unspecified Infection 178 178
Insufficient Information 153 153
Malaise 146 146
Discomfort 142 142
Paresis 138 138
Weight Changes 98 98
Undesired Nerve Stimulation 72 72
Erosion 68 68
No Code Available 64 64
Burning Sensation 63 63
Internal Organ Perforation 56 56
Constipation 54 54
Abdominal Distention 44 44
Obstruction/Occlusion 44 44
Seroma 41 41
Swelling 41 41
Diarrhea 40 40
Hernia 39 39
Muscle Spasm(s) 36 36
Pocket Erosion 35 35
Dehydration 29 29
Staphylococcus Aureus 25 25
Scar Tissue 24 24
Hemorrhage/Bleeding 24 24
Fever 22 22
Sepsis 21 21
Sleep Dysfunction 21 21
Abdominal Cramps 20 20
Test Result 20 20
Erythema 19 19
Bacterial Infection 19 19
Wound Dehiscence 19 19
Adhesion(s) 18 18
Urinary Tract Infection 18 18
Twiddlers Syndrome 18 18
Twitching 18 18
Foreign Body In Patient 18 18
Ambulation Difficulties 18 18
Device Embedded In Tissue or Plaque 17 17
Headache 17 17
Fluid Discharge 16 16
Hematoma 15 15
Device Overstimulation of Tissue 15 15
Weakness 14 14
Inflammation 13 13
Chest Pain 13 13
Cognitive Changes 13 13
Impaired Healing 13 13
Purulent Discharge 12 12
High Blood Pressure/ Hypertension 11 11
Pyrosis/Heartburn 11 11
Foreign Body Reaction 11 11
Cramp(s) 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Swelling/ Edema 10 10
Cramp(s) /Muscle Spasm(s) 10 10
Loss of consciousness 10 10
Disability 10 10
Hypersensitivity/Allergic reaction 10 10
Low Blood Pressure/ Hypotension 10 10
Dyspnea 10 10
Dysphagia/ Odynophagia 9 9
Dizziness 9 9
Tachycardia 9 9
Post Operative Wound Infection 9 9
Depression 9 9
Anxiety 9 9
Distress 9 9
No Information 9 9
Injury 8 8
Seizures 8 8
Skin Erosion 8 8
Necrosis 8 8
Death 8 8
Abscess 8 8
Bruise/Contusion 8 8
Failure of Implant 8 8
Fall 8 8
Eructate 7 7
Shock 7 7
Urinary Retention 7 7
Urinary Frequency 7 7
Lethargy 7 7
Ulcer 6 6
Tingling 6 6
Electrolyte Imbalance 6 6
Thrombosis 6 6
Rash 6 6
Muscle Weakness 6 6
Stroke/CVA 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation II Oct-29-2009
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