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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, autonomic nerve, implanted for stroke rehabilitation
Definition Stimulation of the vagus nerve
Product CodeQPY
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 1 1 0 1

MDR Year MDR Reports MDR Events
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Implant Pain 2 2
Unspecified Infection 1 1
Paresis 1 1
Impaired Healing 1 1
Post Operative Wound Infection 1 1
Tissue Breakdown 1 1
Cough 1 1

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