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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device acute coronary syndrome event detector
Definition Detect Acute Coronary Syndrome events and prompt the patient to seek medical attention.
Product CodeQBI
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
3 2 1 3 0 0

MDR Year MDR Reports MDR Events
2023 9 9
2024 12 12
2025 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Discharge of Battery 25 25
Premature Elective Replacement Indicator 1 1
Insufficient Information 1 1
Battery Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Detachment of Device or Device Component 1 1
Installation-Related Problem 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 41 41
No Clinical Signs, Symptoms or Conditions 11 11
Bacterial Infection 2 2
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Angel Medical Systems, Inc. II Feb-11-2025
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