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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 1 1 1 2 2 2 0 1 1 2 1 5 7 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 3 3
2017 4 4
2018 5 5
2019 10 10
2020 1 1
2021 6 6
2022 5 5
2023 3 3
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 29 29
Defective Device 4 4
Use of Device Problem 2 2
Protective Measures Problem 1 1
Appropriate Term/Code Not Available 1 1
Explosion 1 1
Failure to Conduct 1 1
Display or Visual Feedback Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation 12 12
No Known Impact Or Consequence To Patient 4 4
Atrial Perforation 3 3
Cardiac Perforation 3 3
Pulmonary Valve Stenosis 3 3
Hemorrhage/Bleeding 3 3
Tissue Damage 3 3
Great Vessel Perforation 3 3
No Consequences Or Impact To Patient 2 2
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Blood Loss 1 1
Cardiac Tamponade 1 1
Hernia 1 1
Stenosis 1 1
Stroke/CVA 1 1
Thrombus 1 1

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