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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, electrical, implantable, for incontinence
Definition PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))
Product CodeEZW
Regulation Number 876.5270
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
12 24 26 19 17 23 20 27 27 19 24 43 34 46 32 8

MDR Year MDR Reports MDR Events
2014 4602 4602
2015 5976 5976
2016 7080 7080
2017 8095 8095
2018 5737 5737
2019 4772 4772
2020 4118 4118
2021 4479 4479
2022 4318 4318
2023 5056 5056
2024 1338 1338

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 12100 12100
Adverse Event Without Identified Device or Use Problem 11552 11552
Failure to Deliver Energy 8972 8972
Insufficient Information 6882 6882
Migration or Expulsion of Device 6845 6845
Inappropriate/Inadequate Shock/Stimulation 4917 4917
Unintended Collision 4220 4220
Break 3559 3559
Communication or Transmission Problem 3343 3343
Therapy Delivered to Incorrect Body Area 2934 2934
Battery Problem 2920 2920
Energy Output Problem 2854 2854
Electromagnetic Compatibility Problem 2820 2820
High impedance 2551 2551
Device Displays Incorrect Message 2415 2415
Failure to Interrogate 2137 2137
Electromagnetic Interference 2079 2079
Intermittent Continuity 1547 1547
Malposition of Device 1461 1461
Patient Device Interaction Problem 990 990
Connection Problem 934 934
Overheating of Device 863 863
Impedance Problem 825 825
Unstable 756 756
Device Or Device Fragments Location Unknown 725 725
Positioning Problem 665 665
Pocket Stimulation 661 661
Low Battery 657 657
Unexpected Therapeutic Results 607 607
Premature Discharge of Battery 541 541
Charging Problem 534 534
Data Problem 417 417
Material Deformation 415 415
Disconnection 381 381
Low impedance 356 356
Difficult to Remove 339 339
Environmental Compatibility Problem 240 240
No Device Output 236 236
Application Program Problem 225 225
Display or Visual Feedback Problem 204 204
Energy Output To Patient Tissue Incorrect 199 199
Human-Device Interface Problem 182 182
Appropriate Term/Code Not Available 178 178
Device Contamination with Chemical or Other Material 159 159
Loss of Data 154 154
Inadequate Instructions for Non-Healthcare Professional 147 147
Delayed Charge Time 144 144
Shipping Damage or Problem 142 142
Improper Device Output 141 141
Peeled/Delaminated 135 135
Unable to Obtain Readings 108 108
Vibration 105 105
Therapeutic or Diagnostic Output Failure 79 79
Difficult to Insert 73 73
Migration 72 72
Ambient Noise Problem 68 68
Material Twisted/Bent 59 59
Use of Device Problem 58 58
Stretched 57 57
Device Difficult to Program or Calibrate 55 55
Labelling, Instructions for Use or Training Problem 54 54
Failure to Power Up 52 52
Noise, Audible 48 48
Improper or Incorrect Procedure or Method 46 46
Shelf Life Exceeded 39 39
Degraded 38 38
Compatibility Problem 37 37
Patient-Device Incompatibility 35 35
Electro-Static Discharge 34 34
Component Missing 33 33
Inadequacy of Device Shape and/or Size 31 31
Failure to Charge 27 27
Bent 21 21
Material Perforation 20 20
Mechanical Problem 17 17
Loss of Power 15 15
Entrapment of Device 15 15
Device Inoperable 14 14
Material Integrity Problem 14 14
Unintended Movement 13 13
Device Dislodged or Dislocated 13 13
Device Markings/Labelling Problem 12 12
Defective Device 12 12
Fracture 12 12
Use of Incorrect Control/Treatment Settings 11 11
Loose or Intermittent Connection 11 11
Detachment of Device or Device Component 11 11
Wireless Communication Problem 11 11
Output Problem 11 11
Lack of Effect 11 11
Unauthorized Access to Computer System 10 10
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Unsealed Device Packaging 9 9
Contamination 9 9
Material Protrusion/Extrusion 9 9
Device Sensing Problem 8 8
Inadequate or Insufficient Training 8 8
Defective Component 7 7
Activation, Positioning or Separation Problem 7 7
Self-Activation or Keying 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
Therapeutic Effects, Unexpected 12655 12655
Pain 11113 11113
Therapeutic Response, Decreased 8660 8660
No Known Impact Or Consequence To Patient 8596 8596
Incontinence 7802 7802
Complaint, Ill-Defined 6730 6730
No Clinical Signs, Symptoms or Conditions 5710 5710
Discomfort 5693 5693
Electric Shock 4871 4871
Insufficient Information 4498 4498
Urinary Retention 4456 4456
Urinary Frequency 4207 4207
Undesired Nerve Stimulation 3497 3497
Unspecified Infection 3075 3075
Urinary Tract Infection 2435 2435
Micturition Urgency 1983 1983
Device Overstimulation of Tissue 1960 1960
Burning Sensation 1800 1800
Device Embedded In Tissue or Plaque 1100 1100
Sleep Dysfunction 1063 1063
Ambulation Difficulties 967 967
Constipation 924 924
Diarrhea 885 885
Hemorrhage/Bleeding 833 833
Swelling 676 676
Malaise 574 574
Numbness 482 482
Erythema 454 454
Tingling 439 439
Muscle Spasm(s) 435 435
Fluid Discharge 427 427
Dysuria 427 427
Abdominal Pain 426 426
Itching Sensation 341 341
Pocket Erosion 337 337
Wound Dehiscence 328 328
Urinary Incontinence 291 291
Weight Changes 289 289
Nausea 289 289
Bruise/Contusion 252 252
Fever 243 243
Cramp(s) 243 243
Fall 230 230
Scar Tissue 227 227
Failure of Implant 223 223
Post Operative Wound Infection 219 219
No Code Available 217 217
Bacterial Infection 216 216
Anxiety 210 210
Nerve Damage 206 206
Cramp(s) /Muscle Spasm(s) 205 205
Distress 204 204
Fatigue 203 203
Inflammation 202 202
Irritation 201 201
Swelling/ Edema 198 198
Hypersensitivity/Allergic reaction 197 197
Impaired Healing 192 192
Purulent Discharge 178 178
Staphylococcus Aureus 177 177
Headache 167 167
Shaking/Tremors 165 165
Dizziness 159 159
Twitching 156 156
Paresthesia 152 152
Hematuria 150 150
Foreign Body Reaction 145 145
Flatus 140 140
Vomiting 136 136
Muscular Rigidity 131 131
Rash 123 123
Muscle Weakness 116 116
Abdominal Distention 116 116
Hematoma 113 113
Seizures 111 111
Loss of consciousness 103 103
Fungal Infection 102 102
Erosion 102 102
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 100 100
Weakness 95 95
Cognitive Changes 94 94
Seroma 93 93
Confusion/ Disorientation 82 82
Alteration In Body Temperature 82 82
Abscess 80 80
Dehydration 80 80
Skin Irritation 78 78
Fecal Incontinence 77 77
High Blood Pressure/ Hypertension 75 75
Sepsis 71 71
Skin Erosion 68 68
Test Result 67 67
Injury 66 66
Depression 65 65
Prolapse 65 65
Skin Inflammation/ Irritation 65 65
Irritability 63 63
Chills 62 62
Emotional Changes 61 61
Stroke/CVA 57 57

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation II Aug-10-2023
2 Medtronic Neuromodulation II Apr-22-2022
3 Medtronic Neuromodulation II Nov-24-2021
4 Medtronic Neuromodulation II Jun-07-2019
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