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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device device, removal, pacemaker electrode, percutaneous
Product CodeMFA
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
2 5 6 3 1 1

MDR Year MDR Reports MDR Events
2016 90 90
2017 96 96
2018 77 77
2019 65 65
2020 77 199
2021 57 2863

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 276 2716
Insufficient Information 61 61
Device Operates Differently Than Expected 21 21
Break 18 384
Fracture 9 9
Device Inoperable 7 7
Failure to Advance 7 7
Difficult to Remove 6 6
Appropriate Term/Code Not Available 6 6
Mechanical Jam 5 5
Use of Device Problem 4 4
Hole In Material 4 4
Difficult to Advance 4 4
Kinked 3 3
Pocket Stimulation 3 3
Positioning Problem 3 3
Sticking 3 3
Crack 3 3
Material Split, Cut or Torn 3 3
Temperature Problem 2 2
Bent 2 2
Detachment of Device or Device Component 2 2
Split 2 2
Physical Resistance 2 2
Material Perforation 2 2
Microbial Contamination of Device 2 2
Material Separation 2 2
Thermal Decomposition of Device 2 2
Contamination 2 2
Difficult to Insert 2 2
Material Deformation 2 2
Material Integrity Problem 2 2
Extrusion 1 1
Device Contamination with Chemical or Other Material 1 1
Malposition of Device 1 1
Improper or Incorrect Procedure or Method 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure To Adhere Or Bond 1 1
Entrapment of Device 1 1
Decrease in Pressure 1 1
Misassembled 1 1
Occlusion Within Device 1 1
Scratched Material 1 1
Unintended Movement 1 1
Device Slipped 1 1
Smoking 1 1
Retraction Problem 1 1
Out-Of-Box Failure 1 1
Obstruction of Flow 1 1
Cut In Material 1 1
Positioning Failure 1 1
Difficult to Flush 1 1
Mechanical Problem 1 1
Nonstandard Device 1 1
Overheating of Device 1 123
Deformation Due to Compressive Stress 1 1
Separation Failure 1 1
Human-Device Interface Problem 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Physical Property Issue 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Iatrogenic Source 181 425
Great Vessel Perforation 127 1957
Death 124 246
Perforation of Vessels 107 1815
Low Blood Pressure/ Hypotension 97 97
Injury 59 59
Pericardial Effusion 50 660
Unspecified Infection 35 35
Radiation Exposure, Unintended 23 145
Cardiac Perforation 22 388
Hemorrhage/Bleeding 21 21
Laceration(s) 20 20
Atrial Perforation 17 17
Excessive Tear Production 15 15
Cardiac Tamponade 14 136
No Known Impact Or Consequence To Patient 12 12
Vascular Dissection 11 133
Perforation 11 11
Tissue Damage 11 11
No Consequences Or Impact To Patient 6 6
Nerve Damage 5 5
Blood Loss 5 5
No Code Available 4 4
Pleural Effusion 4 126
Ventricular Tachycardia 4 4
Unintended Radiation Exposure 4 370
Rupture 3 3
Exsanguination 3 3
Hematoma 3 125
Bacterial Infection 3 3
Cardiac Arrest 3 3
Hemothorax 3 3
Burning Sensation 3 125
Vascular System (Circulation), Impaired 3 3
Foreign Body In Patient 2 2
Fistula 2 2
Tricuspid Regurgitation 2 2
Pneumothorax 2 2
Pocket Erosion 2 2
Burn(s) 2 2
Hypovolemia 2 2
Respiratory Acidosis 1 1
Low Cardiac Output 1 1
Cardiopulmonary Arrest 1 1
High Blood Pressure/ Hypertension 1 1
Sepsis 1 1
Thrombosis 1 1
Occlusion 1 1
No Clinical Signs, Symptoms or Conditions 1 123
Foreign Body Embolism 1 1
Vaso-Vagal Response 1 1
Superficial (First Degree) Burn 1 1
Tachycardia 1 1
Internal Organ Perforation 1 1
Pain 1 1
Radiation Overdose 1 1
Adhesion(s) 1 1
Embolism 1 1
Embolus 1 1
Eye Injury 1 1
Twiddlers Syndrome 1 1
Ventricular Fibrillation 1 1
Hypoglycemia 1 1
Burn, Thermal 1 1
Mitral Perforation 1 1
Impaired Healing 1 1
Obstruction/Occlusion 1 123
Brain Injury 1 1
Cusp Tear 1 1
Tricuspid Valve Insufficiency/ Regurgitation 1 1
Device Embedded In Tissue or Plaque 1 1

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