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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, tibial, electrical, implantable, for urinary incontinence
Definition Implanted electrical stimulator, including implanted power source, for treatment of overactive bladder or symptoms of overactive bladder through electrical stimulation of the tibial nerve.
Product CodeQPT
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 4 2 0 7 5

MDR Year MDR Reports MDR Events
2022 1 1
2023 11 11
2024 9 9
2025 7 7
2026 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 32 32
Use of Device Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Post Operative Wound Infection 24 24
Fluid Discharge 5 5
Swelling/ Edema 5 5
Erythema 5 5
Unspecified Infection 4 4
Burning Sensation 3 3
Hypersensitivity/Allergic reaction 3 3
Purulent Discharge 3 3
Impaired Healing 2 2
Skin Inflammation/ Irritation 2 2
Cellulitis 2 2
Wound Dehiscence 1 1
Discomfort 1 1
Pain 1 1
Insufficient Information 1 1
Skin Infection 1 1

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