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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 0 0 0 0 0 4 2 0

MDR Year MDR Reports MDR Events
2022 1 1
2023 11 11
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
Post Operative Wound Infection 16 16
Skin Inflammation/ Irritation 1 1
Cellulitis 1 1
Purulent Discharge 1 1

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