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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 0

MDR Year MDR Reports MDR Events
2019 65 65
2020 77 199
2021 83 3011
2022 60 60
2023 55 55
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 304 2866
Break 19 385
Material Separation 10 10
Material Split, Cut or Torn 6 6
Deformation Due to Compressive Stress 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
Human-Device Interface Problem 1 1
Sharp Edges 1 1
Temperature Problem 1 1
Use of Device Problem 1 1
Overheating of Device 1 123

Patient Problems MDRs with this Patient Problem Events in those MDRs
Great Vessel Perforation 221 2051
Iatrogenic Source 132 376
Perforation of Vessels 110 1818
Pericardial Effusion 61 671
Cardiac Perforation 59 425
Death 44 166
Unintended Radiation Exposure 28 394
Atrial Perforation 16 16
Radiation Exposure, Unintended 16 138
Pleural Effusion 10 132
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
Laceration(s) 3 3
Burning Sensation 3 125
Hematoma 3 125
No Known Impact Or Consequence To Patient 3 3
Vascular Dissection 2 124
Embolism/Embolus 2 124
Foreign Body Embolism 2 2
No Consequences Or Impact To Patient 2 2
Tricuspid Regurgitation 2 2
Ventricular Tachycardia 2 2
Thrombosis 1 1
Brain Injury 1 1
Perforation 1 1
Embolus 1 1
Burn(s) 1 1
Stroke/CVA 1 1
Tricuspid Valve Insufficiency/ Regurgitation 1 1
Obstruction/Occlusion 1 123
Low Cardiac Output 1 1
Mitral Perforation 1 1
Pseudoaneurysm 1 1
Superficial (First Degree) Burn 1 1

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