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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 1

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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6470 6470
Insufficient Information 6216 6217
Migration or Expulsion of Device 3902 3903
Failure to Deliver Energy 2758 2758
Inappropriate/Inadequate Shock/Stimulation 2532 2532
Communication or Transmission Problem 2341 2341
Energy Output Problem 2309 2309
Battery Problem 2084 2084
Break 1765 1767
Unintended Collision 1685 1685
Failure to Interrogate 1624 1624
Electromagnetic Compatibility Problem 1360 1360
High impedance 1245 1246
Therapy Delivered to Incorrect Body Area 1059 1059
Electromagnetic Interference 1040 1040
Malposition of Device 981 981
Charging Problem 803 803
Patient Device Interaction Problem 697 697
Intermittent Continuity 478 478
Unstable 448 448
Overheating of Device 439 439
Data Problem 409 409
Premature Discharge of Battery 363 363
Impedance Problem 356 357
Positioning Problem 351 351
Difficult to Remove 340 340
Migration 339 339
Pocket Stimulation 298 298
Connection Problem 278 278
Therapeutic or Diagnostic Output Failure 272 272
Disconnection 239 239
Material Deformation 213 213
Application Program Problem 200 200
Delayed Charge Time 179 179
Display or Visual Feedback Problem 151 151
Failure to Power Up 148 148
Vibration 119 119
Lack of Effect 84 84
Environmental Compatibility Problem 80 80
Human-Device Interface Problem 69 69
No Device Output 69 69
Low impedance 66 66
Appropriate Term/Code Not Available 62 62
Failure to Charge 55 55
Difficult to Insert 52 52
Fracture 51 51
Loss of Data 48 48
Improper or Incorrect Procedure or Method 43 43
Noise, Audible 37 37
Use of Device Problem 36 36

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9461 9465
Insufficient Information 7068 7068
Pain 5115 5115
Incontinence 3232 3232
Electric Shock 2518 2518
Discomfort 2461 2461
Urinary Retention 1830 1830
Urinary Frequency 1591 1591
Unspecified Infection 1493 1493
Undesired Nerve Stimulation 1397 1397
Burning Sensation 779 779
Urinary Incontinence 681 681
Micturition Urgency 670 670
Device Embedded In Tissue or Plaque 656 656
Device Overstimulation of Tissue 605 605
Sleep Dysfunction 436 436
Urinary Tract Infection 430 430
Ambulation Difficulties 414 414
Hemorrhage/Bleeding 410 410
Constipation 374 374
Swelling/ Edema 332 332
Cramp(s) /Muscle Spasm(s) 325 325
Diarrhea 303 303
Dysuria 238 238
Paresthesia 230 230
Failure of Implant 230 230
Wound Dehiscence 200 200
Numbness 195 195
Malaise 193 193
Fecal Incontinence 191 191
Implant Pain 185 185
Fluid Discharge 178 178
Erythema 174 174
Pocket Erosion 148 148
Itching Sensation 146 146
Weight Changes 129 129
Scar Tissue 122 122
Skin Inflammation/ Irritation 111 111
Bacterial Infection 107 107
Bruise/Contusion 105 105
Nausea 103 103
Impaired Healing 99 99
Inflammation 92 92
Hypersensitivity/Allergic reaction 91 91
Nerve Damage 85 85
Erosion 81 81
Hematoma 81 81
Fever 76 76
Purulent Discharge 73 73
Post Operative Wound Infection 69 69

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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