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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
Regulation Description Implanted electrical urinary continence device.
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)
2021 2022 2023 2024 2025 2026
34 46 32 35 36 29

MDR Year MDR Reports MDR Events
2021 4479 4479
2022 4318 4320
2023 5056 5056
2024 5773 5774
2025 7045 7046
2026 3199 3200

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7204 7205
Insufficient Device Problem Information 7010 7011
Migration or Expulsion of Device 4318 4319
Failure to Deliver Energy 3041 3041
Inappropriate/Inadequate Shock/Stimulation 2807 2807
Communication or Transmission Problem 2617 2617
Energy Output Problem 2562 2562
Battery Problem 2279 2279
Break 1891 1893
Unintended Collision 1864 1864
Failure to Interrogate 1777 1777
Electromagnetic Compatibility Problem 1644 1644
High impedance 1386 1387
Therapy Delivered to Incorrect Body Area 1225 1225
Electromagnetic Interference 1187 1187
Malposition of Device 1108 1108
Charging Problem 881 881
Patient Device Interaction Problem 782 782
Intermittent Continuity 556 556
Overheating of Device 497 497
Unstable 495 495
Data Problem 462 462
Premature Discharge of Battery 461 461
Migration 444 444
Impedance Problem 406 407
Positioning Problem 378 378
Difficult to Remove 374 374
Therapeutic or Diagnostic Output Failure 334 334
Extracardiac stimulation 323 323
Connection Problem 307 307
Disconnection 289 289
Material Deformation 241 241
Application Program Problem 201 201
Delayed Charge Time 193 193
Failure to Power Up 170 170
Display or Visual Feedback Problem 160 160
Vibration 138 138
Lack of Effect 94 94
Environmental Compatibility Problem 90 90
No Device Output 90 90
Fracture 77 77
Human-Device Interface Problem 75 75
Low impedance 71 71
Appropriate Device Problem Term/Code Not Available 66 66
Difficult to Insert 57 57
Loss of Data 55 55
Failure to Charge 53 53
Improper or Incorrect Procedure or Method 46 46
Material Twisted/Bent 42 42
Noise, Audible 41 41

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10589 10593
Insufficient Information 7941 7941
Pain 5721 5721
Incontinence 3573 3573
Electric Shock 2793 2793
Discomfort 2786 2786
Urinary Retention 2057 2057
Urinary Frequency / Polyuria 1838 1838
Unspecified Infection 1635 1635
Undesired Nerve Stimulation 1457 1457
Burning Sensation 879 880
Urinary Incontinence 811 811
Micturition Urgency 771 771
Device Embedded In Tissue or Plaque 691 691
Device Overstimulation of Tissue 668 668
Sleep Dysfunction 506 506
Urinary Tract Infection 475 475
Ambulation or Postural Difficulties 454 454
Hemorrhage/Blood Loss/Bleeding 446 446
Constipation 404 404
Swelling/ Edema 373 373
Cramp(s) /Muscle Spasm(s) 366 366
Diarrhea 320 320
Dysuria 274 274
Paresthesia 258 258
Wound Dehiscence 237 237
Fecal Incontinence 237 237
Implant Pain 234 234
Failure of Implant 232 232
Numbness 221 221
Malaise 204 204
Fluid Discharge 197 197
Erythema 187 187
Inappropriate Device Stimulation of Tissue 178 178
Weight Changes 160 160
Itching Sensation 158 158
Pocket Erosion 157 157
Scar Tissue 135 135
Skin Inflammation/ Irritation 123 123
Bruise/Contusion 118 118
Bacterial Infection 117 117
Inflammation 114 114
Nausea 111 111
Impaired Healing 105 105
Hypersensitivity/Allergic reaction 100 100
Nerve Damage 95 95
Erosion 89 89
Fever 87 87
Hematoma 87 87
Purulent Discharge 80 80

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation II Apr-30-2025
2 Medtronic Neuromodulation II Sep-06-2024
3 Medtronic Neuromodulation II Aug-10-2023
4 Medtronic Neuromodulation II Apr-22-2022
5 Medtronic Neuromodulation II Nov-24-2021
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