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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, pacing and cardioversion, temporary, epicardial
Definition The System is indicated for use in postoperative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion. Epicardial defibrillation electrodes can be implanted up to 7 days.
Product CodeNHW
Regulation Number 870.3680
Device Class 2

MDR Year MDR Reports MDR Events
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 2 2

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