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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 12

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 2254 2254

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 11779 11779
Failure to Deliver Energy 9075 9075
Insufficient Information 7100 7100
Migration or Expulsion of Device 7016 7016
Inappropriate/Inadequate Shock/Stimulation 4985 4985
Unintended Collision 4292 4292
Break 3630 3630
Communication or Transmission Problem 3417 3417
Battery Problem 2978 2978
Therapy Delivered to Incorrect Body Area 2961 2961
Energy Output Problem 2935 2935
Electromagnetic Compatibility Problem 2867 2867
High impedance 2605 2605
Device Displays Incorrect Message 2415 2415
Failure to Interrogate 2185 2185
Electromagnetic Interference 2120 2120
Intermittent Continuity 1561 1561
Malposition of Device 1487 1487
Patient Device Interaction Problem 1008 1008
Connection Problem 946 946
Overheating of Device 880 880
Impedance Problem 835 835
Unstable 774 774
Device Or Device Fragments Location Unknown 725 725
Positioning Problem 675 675
Pocket Stimulation 671 671
Low Battery 657 657
Unexpected Therapeutic Results 607 607
Premature Discharge of Battery 564 564
Charging Problem 553 553
Data Problem 431 431
Material Deformation 421 421
Disconnection 391 391
Low impedance 359 359
Difficult to Remove 354 354
Environmental Compatibility Problem 242 242
No Device Output 238 238
Application Program Problem 225 225
Display or Visual Feedback Problem 209 209
Energy Output To Patient Tissue Incorrect 199 199
Human-Device Interface Problem 183 183
Appropriate Term/Code Not Available 179 179
Device Contamination with Chemical or Other Material 160 160
Loss of Data 155 155
Inadequate Instructions for Non-Healthcare Professional 147 147
Delayed Charge Time 147 147
Shipping Damage or Problem 143 143
Improper Device Output 141 141
Peeled/Delaminated 135 135
Vibration 112 112
Unable to Obtain Readings 109 109
Therapeutic or Diagnostic Output Failure 105 105
Migration 77 77
Difficult to Insert 74 74
Ambient Noise Problem 68 68
Material Twisted/Bent 60 60
Stretched 58 58
Use of Device Problem 58 58
Device Difficult to Program or Calibrate 55 55
Labelling, Instructions for Use or Training Problem 54 54
Failure to Power Up 53 53
Noise, Audible 49 49
Improper or Incorrect Procedure or Method 46 46
Shelf Life Exceeded 39 39
Degraded 38 38
Electro-Static Discharge 37 37
Compatibility Problem 37 37
Patient-Device Incompatibility 35 35
Component Missing 33 33
Failure to Charge 32 32
Inadequacy of Device Shape and/or Size 31 31
Material Perforation 23 23
Bent 21 21
Mechanical Problem 17 17
Lack of Effect 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
Fracture 13 13
Device Markings/Labelling Problem 12 12
Defective Device 12 12
Unauthorized Access to Computer System 12 12
Wireless Communication Problem 11 11
Output Problem 11 11
Detachment of Device or Device Component 11 11
Use of Incorrect Control/Treatment Settings 11 11
Loose or Intermittent Connection 11 11
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 11283 11283
Therapeutic Response, Decreased 8660 8660
No Known Impact Or Consequence To Patient 8596 8596
Incontinence 7951 7951
Complaint, Ill-Defined 6730 6730
No Clinical Signs, Symptoms or Conditions 6060 6060
Discomfort 5776 5776
Electric Shock 4940 4940
Insufficient Information 4739 4739
Urinary Retention 4511 4511
Urinary Frequency 4251 4251
Undesired Nerve Stimulation 3532 3532
Unspecified Infection 3124 3124
Urinary Tract Infection 2440 2440
Micturition Urgency 2009 2009
Device Overstimulation of Tissue 1975 1975
Burning Sensation 1822 1822
Device Embedded In Tissue or Plaque 1127 1127
Sleep Dysfunction 1077 1077
Ambulation Difficulties 981 981
Constipation 945 945
Diarrhea 903 903
Hemorrhage/Bleeding 851 851
Swelling 676 676
Malaise 583 583
Numbness 495 495
Erythema 456 456
Tingling 439 439
Muscle Spasm(s) 435 435
Dysuria 435 435
Fluid Discharge 431 431
Abdominal Pain 430 430
Itching Sensation 345 345
Pocket Erosion 342 342
Wound Dehiscence 341 341
Urinary Incontinence 308 308
Nausea 295 295
Weight Changes 293 293
Bruise/Contusion 254 254
Fever 244 244
Cramp(s) 243 243
Failure of Implant 242 242
Fall 230 230
Scar Tissue 230 230
Bacterial Infection 222 222
Post Operative Wound Infection 219 219
Cramp(s) /Muscle Spasm(s) 219 219
No Code Available 217 217
Swelling/ Edema 212 212
Anxiety 211 211
Nerve Damage 210 210
Distress 205 205
Inflammation 204 204
Fatigue 204 204
Irritation 201 201
Hypersensitivity/Allergic reaction 199 199
Impaired Healing 198 198
Purulent Discharge 181 181
Staphylococcus Aureus 177 177
Headache 172 172
Paresthesia 167 167
Shaking/Tremors 165 165
Dizziness 163 163
Twitching 157 157
Hematuria 151 151
Foreign Body Reaction 147 147
Flatus 143 143
Vomiting 138 138
Muscular Rigidity 133 133
Rash 123 123
Muscle Weakness 119 119
Abdominal Distention 118 118
Hematoma 117 117
Seizures 111 111
Erosion 105 105
Loss of consciousness 104 104
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 103 103
Fungal Infection 102 102
Seroma 96 96
Weakness 95 95
Cognitive Changes 94 94
Confusion/ Disorientation 82 82
Alteration In Body Temperature 82 82
Dehydration 82 82
Abscess 80 80
Fecal Incontinence 80 80
Skin Irritation 78 78
High Blood Pressure/ Hypertension 75 75
Sepsis 72 72
Skin Erosion 68 68
Test Result 67 67
Injury 66 66
Depression 65 65
Irritability 65 65
Chills 65 65
Prolapse 65 65
Skin Inflammation/ Irritation 65 65
Emotional Changes 61 61
Stroke/CVA 58 58

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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