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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, removal, pacemaker electrode, percutaneous
Product CodeMFA
Device Class 3

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

MDR Year MDR Reports MDR Events
2021 83 3011
2022 60 60
2023 55 55
2024 70 70
2025 68 68
2026 85 85

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 357 2919
Material Separation 38 38
Break 12 256
Deformation Due to Compressive Stress 7 7
Entrapment of Device 4 4
Material Split, Cut or Torn 3 3
Material Puncture/Hole 2 2
Material Deformation 2 2
Migration or Expulsion of Device 1 1
Positioning Failure 1 1
Use of Device Problem 1 1
Sharp Edges 1 1
Overheating of Device 1 123

Patient Problems MDRs with this Patient Problem Events in those MDRs
Great Vessel Perforation 252 2082
Perforation of Vessels 106 1814
Pericardial Effusion 101 711
Cardiac Perforation 86 452
Unintended Radiation Exposure 55 421
Pleural Effusion 19 141
Cardiac Tamponade 14 136
No Clinical Signs, Symptoms or Conditions 11 133
Iatrogenic Source 8 252
Hematoma 7 129
Hemorrhage/Blood Loss/Bleeding 7 7
Sepsis 6 6
Stroke/CVA 5 5
Hemothorax 5 5
Pulmonary Embolism 4 4
Paralysis 4 4
Hypovolemic Shock 3 3
Death 3 125
Embolism/Embolus 3 125
Obstruction/Occlusion 3 125
Heart Failure/Congestive Heart Failure 3 3
Laceration(s) 3 3
Low Blood Pressure/ Hypotension 2 2
Pseudoaneurysm 2 2
Dyspnea 2 2
Insufficient Information 2 2
Foreign Body Embolism 2 2
Chest Pain 2 2
Thrombosis/Thrombus 2 2
Multiple Organ Dysfunction Syndrome 2 2
Perforation 2 2
Tricuspid Valve Insufficiency/ Regurgitation 2 2
Vascular Dissection 2 124
Arrhythmia 2 2
Wound Infection 1 1
Burning Sensation 1 123
Ventricular Fibrillation 1 1
Cardiomyopathy 1 1
Low Cardiac Output 1 1
Pulmonary Edema 1 1
Shock 1 1
Swelling/ Edema 1 1
Drug Resistant Bacterial Infection 1 1
Electric Shock 1 1
Fistula 1 1
Cerebral Edema 1 1
Abdominal Pain 1 1

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