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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 20

MDR Year MDR Reports MDR Events
2014 4603 4603
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 3808 3808

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 12156 12156
Device Operates Differently Than Expected 12100 12100
Failure to Deliver Energy 9206 9206
Insufficient Information 7476 7476
Migration or Expulsion of Device 7232 7232
Inappropriate/Inadequate Shock/Stimulation 5123 5123
Unintended Collision 4393 4393
Break 3735 3735
Communication or Transmission Problem 3564 3564
Energy Output Problem 3093 3093
Battery Problem 3059 3059
Therapy Delivered to Incorrect Body Area 3011 3011
Electromagnetic Compatibility Problem 2944 2944
High impedance 2681 2681
Device Displays Incorrect Message 2415 2415
Failure to Interrogate 2306 2306
Electromagnetic Interference 2167 2167
Intermittent Continuity 1579 1579
Malposition of Device 1548 1548
Patient Device Interaction Problem 1057 1057
Connection Problem 964 964
Overheating of Device 902 902
Impedance Problem 856 856
Unstable 795 795
Device Or Device Fragments Location Unknown 725 725
Pocket Stimulation 690 690
Positioning Problem 687 687
Low Battery 657 657
Unexpected Therapeutic Results 607 607
Premature Discharge of Battery 594 594
Charging Problem 593 593
Data Problem 463 463
Material Deformation 435 435
Disconnection 405 405
Difficult to Remove 376 376
Low impedance 361 361
Environmental Compatibility Problem 243 243
No Device Output 242 242
Application Program Problem 225 225
Display or Visual Feedback Problem 220 220
Energy Output To Patient Tissue Incorrect 199 199
Human-Device Interface Problem 186 186
Appropriate Term/Code Not Available 179 179
Device Contamination with Chemical or Other Material 162 162
Loss of Data 161 161
Delayed Charge Time 156 156
Inadequate Instructions for Non-Healthcare Professional 147 147
Shipping Damage or Problem 146 146
Improper Device Output 141 141
Peeled/Delaminated 135 135

Patient Problems MDRs with this Patient Problem Events in those MDRs
Therapeutic Effects, Unexpected 12655 12655
Pain 11575 11575
Therapeutic Response, Decreased 8660 8660
No Known Impact Or Consequence To Patient 8596 8596
Incontinence 8207 8207
Complaint, Ill-Defined 6730 6730
No Clinical Signs, Symptoms or Conditions 6632 6632
Discomfort 5916 5916
Insufficient Information 5148 5148
Electric Shock 5077 5077
Urinary Retention 4609 4609
Urinary Frequency 4328 4328
Undesired Nerve Stimulation 3599 3599
Unspecified Infection 3220 3220
Urinary Tract Infection 2460 2460
Micturition Urgency 2047 2047
Device Overstimulation of Tissue 2025 2025
Burning Sensation 1862 1862
Device Embedded In Tissue or Plaque 1163 1163
Sleep Dysfunction 1104 1104
Ambulation Difficulties 1002 1002
Constipation 962 962
Diarrhea 922 922
Hemorrhage/Bleeding 880 880
Swelling 676 676
Malaise 597 597
Numbness 507 507
Erythema 466 466
Dysuria 448 448
Fluid Discharge 442 442
Tingling 439 439
Abdominal Pain 435 435
Muscle Spasm(s) 435 435
Itching Sensation 358 358
Wound Dehiscence 355 355
Pocket Erosion 350 350
Urinary Incontinence 331 331
Weight Changes 298 298
Nausea 298 298
Bruise/Contusion 260 260
Failure of Implant 252 252
Fever 246 246
Cramp(s) 243 243
Cramp(s) /Muscle Spasm(s) 240 240
Scar Tissue 237 237
Fall 234 234
Swelling/ Edema 230 230
Bacterial Infection 228 228
Post Operative Wound Infection 226 226
No Code Available 217 217

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation II Sep-06-2024
2 Medtronic Neuromodulation II Aug-10-2023
3 Medtronic Neuromodulation II Apr-22-2022
4 Medtronic Neuromodulation II Nov-24-2021
5 Medtronic Neuromodulation II Jun-07-2019
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