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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device surgical cardiac ablation device, for treatment of atrial fibrillation
Definition Surgical cardiac ablation for the treatment of atrial fibrillation.
Product CodeOCM
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
1 2 1 5 7 2

MDR Year MDR Reports MDR Events
2019 10 10
2020 1 1
2021 6 6
2022 5 5
2023 3 3
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 23 23
Defective Device 4 4
Use of Device Problem 2 2
Explosion 1 1
Labelling, Instructions for Use or Training Problem 1 1
Appropriate Term/Code Not Available 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation 6 6
No Known Impact Or Consequence To Patient 3 3
Cardiac Perforation 3 3
Pulmonary Valve Stenosis 3 3
Stroke/CVA 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Insufficient Information 2 2
Great Vessel Perforation 2 2
No Consequences Or Impact To Patient 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pericardial Effusion 1 1
Cardiac Tamponade 1 1
Pericarditis 1 1
Ventricular Fibrillation 1 1
Hernia 1 1
Heart Failure/Congestive Heart Failure 1 1
Stenosis 1 1
Hemorrhage/Bleeding 1 1
Thrombus 1 1
Ischemia Stroke 1 1

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