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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 26

MDR Year MDR Reports MDR Events
2021 4479 4479
2022 4318 4320
2023 5056 5056
2024 5773 5774
2025 7045 7046
2026 2656 2656

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7089 7089
Insufficient Information 6884 6885
Migration or Expulsion of Device 4253 4254
Failure to Deliver Energy 2983 2983
Inappropriate/Inadequate Shock/Stimulation 2769 2769
Communication or Transmission Problem 2574 2574
Energy Output Problem 2516 2516
Battery Problem 2250 2250
Break 1868 1870
Unintended Collision 1836 1836
Failure to Interrogate 1751 1751
Electromagnetic Compatibility Problem 1583 1583
High impedance 1359 1360
Therapy Delivered to Incorrect Body Area 1201 1201
Electromagnetic Interference 1159 1159
Malposition of Device 1086 1086
Charging Problem 875 875
Patient Device Interaction Problem 774 774
Intermittent Continuity 543 543
Unstable 490 490
Overheating of Device 485 485
Data Problem 450 450
Premature Discharge of Battery 449 449
Migration 427 427
Impedance Problem 395 396
Positioning Problem 373 373
Difficult to Remove 367 367
Therapeutic or Diagnostic Output Failure 333 333
Pocket Stimulation 322 322
Connection Problem 299 299
Disconnection 284 284
Material Deformation 233 233
Application Program Problem 202 202
Delayed Charge Time 192 192
Failure to Power Up 169 169
Display or Visual Feedback Problem 159 159
Vibration 137 137
Lack of Effect 91 91
Environmental Compatibility Problem 89 89
No Device Output 85 85
Human-Device Interface Problem 75 75
Fracture 75 75
Low impedance 69 69
Appropriate Term/Code Not Available 68 68
Difficult to Insert 56 56
Failure to Charge 56 56
Loss of Data 52 52
Improper or Incorrect Procedure or Method 45 45
Use of Device Problem 43 43
Noise, Audible 41 41

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10406 10410
Insufficient Information 7794 7794
Pain 5614 5614
Incontinence 3500 3500
Electric Shock 2748 2748
Discomfort 2727 2727
Urinary Retention 2016 2016
Urinary Frequency 1784 1784
Unspecified Infection 1613 1613
Undesired Nerve Stimulation 1457 1457
Burning Sensation 865 865
Urinary Incontinence 795 795
Micturition Urgency 751 751
Device Embedded In Tissue or Plaque 683 683
Device Overstimulation of Tissue 649 649
Sleep Dysfunction 491 491
Urinary Tract Infection 466 466
Ambulation Difficulties 448 448
Hemorrhage/Bleeding 439 439
Constipation 400 400
Swelling/ Edema 361 361
Cramp(s) /Muscle Spasm(s) 355 355
Diarrhea 315 315
Dysuria 270 270
Paresthesia 253 253
Failure of Implant 231 231
Wound Dehiscence 230 230
Fecal Incontinence 229 229
Implant Pain 225 225
Numbness 216 216
Malaise 202 202
Fluid Discharge 194 194
Erythema 186 186
Itching Sensation 157 157
Pocket Erosion 155 155
Weight Changes 155 155
Scar Tissue 134 134
Skin Inflammation/ Irritation 122 122
Bacterial Infection 117 117
Bruise/Contusion 114 114
Nausea 110 110
Inflammation 110 110
Impaired Healing 103 103
Hypersensitivity/Allergic reaction 99 99
Nerve Damage 95 95
Erosion 89 89
Fever 85 85
Hematoma 84 84
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 76 76
Purulent Discharge 76 76

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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