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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implanted phrenic nerve stimulator for central sleep apnea
Definition The device is intended to stimulate the phrenic nerve to produce diaphragm movement during sleep.
Product CodePSR
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
1 1 2 0 1 0

MDR Year MDR Reports MDR Events
2022 2 2
2025 6 6
2026 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 28 28
Compatibility Problem 2 2
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Post Operative Wound Infection 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Hematoma 3 3
Thrombosis/Thrombus 3 3
Pocket Erosion 3 3
Pain 2 2
Sleep Dysfunction 1 1
Weight Changes 1 1
Fatigue 1 1
Failure of Implant 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Chest Pain 1 1
Dyspnea 1 1
Swelling/ Edema 1 1

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