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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 7

MDR Year MDR Reports MDR Events
2022 1 1
2023 11 11
2024 9 9
2025 7 7
2026 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 41 41
Use of Device Problem 3 3
Insufficient Information 1 1
Charging Problem 1 1
Failure to Power Up 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Post Operative Wound Infection 26 26
Unspecified Infection 8 8
Erythema 8 8
Fluid Discharge 7 7
Swelling/ Edema 7 7
Hypersensitivity/Allergic reaction 4 4
Burning Sensation 4 4
Pain 4 4
Wound Dehiscence 3 3
Purulent Discharge 3 3
Cellulitis 3 3
Discomfort 3 3
Impaired Healing 2 2
Skin Infection 2 2
Skin Inflammation/ Irritation 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Inflammation 1 1
Insufficient Information 1 1
Scar Tissue 1 1
Ambulation Difficulties 1 1

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