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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 102 102

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 769 769
Device Operates Differently Than Expected 554 554
Inappropriate/Inadequate Shock/Stimulation 427 427
Insufficient Information 281 281
Migration or Expulsion of Device 261 261
High impedance 200 200
Electromagnetic Compatibility Problem 158 158
Break 147 147
Battery Problem 134 134
Premature Discharge of Battery 108 108
Failure to Deliver Energy 99 99
Unstable 93 93
Low Battery 89 89
Impedance Problem 88 88
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
Appropriate Term/Code Not Available 24 24
Device Displays Incorrect Message 20 20
Connection Problem 15 15
Low impedance 15 15
Human-Device Interface Problem 13 13
Environmental Compatibility Problem 13 13
Shipping Damage or Problem 11 11
Device Contamination with Chemical or Other Material 11 11
Shelf Life Exceeded 10 10
Degraded 10 10
Unexpected Therapeutic Results 9 9
Material Erosion 8 8
Energy Output To Patient Tissue Incorrect 7 7
Vibration 6 6
Noise, Audible 6 6
Patient-Device Incompatibility 5 5
No Device Output 5 5
Electro-Static Discharge 5 5
Device Dislodged or Dislocated 5 5
Migration 5 5

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 444 444
Electric Shock 426 426
Complaint, Ill-Defined 401 401
Therapeutic Response, Decreased 391 391
Therapeutic Effects, Unexpected 323 323
No Clinical Signs, Symptoms or Conditions 197 197
Unspecified Infection 184 184
Abdominal Pain 178 178
Insufficient Information 157 157
Malaise 146 146
Discomfort 143 143
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
Failure of Implant 43 43
Swelling 41 41
Seroma 41 41
Diarrhea 40 40
Hernia 39 39
Muscle Spasm(s) 36 36
Pocket Erosion 35 35
Dehydration 29 29
Staphylococcus Aureus 25 25
Hemorrhage/Bleeding 24 24
Scar Tissue 24 24
Fever 22 22
Sepsis 21 21
Sleep Dysfunction 21 21
Abdominal Cramps 20 20
Test Result 20 20
Wound Dehiscence 19 19
Erythema 19 19
Bacterial Infection 19 19
Foreign Body In Patient 18 18
Twitching 18 18
Ambulation Difficulties 18 18
Urinary Tract Infection 18 18
Adhesion(s) 18 18
Twiddlers Syndrome 18 18
Headache 17 17

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