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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)
2019 2020 2021 2022 2023 2024
3 1 1 0 1 1

MDR Year MDR Reports MDR Events
2019 65 65
2020 77 199
2021 83 3011
2022 60 60
2023 55 55
2024 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 325 2887
Material Separation 19 19
Break 19 385
Deformation Due to Compressive Stress 7 7
Material Split, Cut or Torn 6 6
Mechanical Jam 3 3
Entrapment of Device 3 3
Fracture 3 3
Crack 2 2
Material Puncture/Hole 2 2
Material Perforation 2 2
Material Deformation 2 2
Use of Device Problem 1 1
Human-Device Interface Problem 1 1
Overheating of Device 1 123
Temperature Problem 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Great Vessel Perforation 239 2069
Iatrogenic Source 132 376
Perforation of Vessels 116 1824
Pericardial Effusion 65 675
Cardiac Perforation 63 429
Death 44 166
Unintended Radiation Exposure 37 403
Radiation Exposure, Unintended 16 138
Atrial Perforation 16 16
Pleural Effusion 12 134
Cardiac Tamponade 8 130
Low Blood Pressure/ Hypotension 6 6
No Clinical Signs, Symptoms or Conditions 5 127
Hemorrhage/Bleeding 4 4
Hemothorax 4 4
Hematoma 3 125
No Known Impact Or Consequence To Patient 3 3
Burning Sensation 3 125
Laceration(s) 3 3
Ventricular Tachycardia 2 2
Vascular Dissection 2 124
Embolism/Embolus 2 124
Foreign Body Embolism 2 2
Tricuspid Regurgitation 2 2
No Consequences Or Impact To Patient 2 2
Superficial (First Degree) Burn 1 1
Stroke/CVA 1 1
Brain Injury 1 1
Tricuspid Valve Insufficiency/ Regurgitation 1 1
Perforation 1 1
Mitral Perforation 1 1
Obstruction/Occlusion 1 123
Low Cardiac Output 1 1
Burn(s) 1 1
Thrombosis 1 1
Pseudoaneurysm 1 1
Embolus 1 1

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