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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device diaphragmatic/phrenic nerve laparoscopically-implanted stimulator
Definition The device is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older.
Product CodeOIR
Device Class 3

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

MDR Year MDR Reports MDR Events
2019 1 1
2021 2 2
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Electrical /Electronic Property Problem 1 1
Electrical Overstress 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Arrhythmia 2 2
Abdominal Pain 1 1
Cardiac Arrest 1 1
Ventricular Fibrillation 1 1
Undesired Nerve Stimulation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Synapse Biomedical Inc I Aug-22-2022
2 Synapse Biomedical Inc III Jul-18-2022
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