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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, electrode recording, or probe, electrode recording
Regulation Description Electrode recording catheter or electrode recording probe.
Product CodeDRF
Regulation Number 870.1220
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONICK, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
CATHRX, LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMRICOR MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
7 3 1 2 1 0

MDR Year MDR Reports MDR Events
2021 625 625
2022 613 615
2023 685 686
2024 623 625
2025 514 514
2026 159 159

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 952 954
Material Twisted/Bent 516 517
Patient Device Interaction Problem 389 389
Material Deformation 266 266
Entrapment of Device 163 165
Fracture 118 118
Material Integrity Problem 115 115
Signal Artifact/Noise 102 102
Compatibility Problem 83 83
Communication or Transmission Problem 76 76
Mechanical Problem 71 71
Difficult to Remove 67 67
Material Separation 59 60
Contamination /Decontamination Problem 50 50
Detachment of Device or Device Component 49 49
Break 43 43
Display or Visual Feedback Problem 41 41
Activation, Positioning or Separation Problem 38 38
Fluid/Blood Leak 36 36
Material Protrusion/Extrusion 34 34
Mechanical Jam 30 30
Material Perforation 29 29
Coagulation in Device or Device Ingredient 28 28
Device Contamination with Body Fluid 28 28
Difficult to Insert 27 27
Leak/Splash 25 25
Insufficient Information 25 25
Device-Device Incompatibility 24 24
Obstruction of Flow 23 23
Positioning Problem 23 23
Material Frayed 22 22
Defective Device 22 22
Delivered as Unsterile Product 21 21
Manufacturing, Packaging or Shipping Problem 20 20
Improper or Incorrect Procedure or Method 19 19
Tear, Rip or Hole in Device Packaging 18 18
Improper Flow or Infusion 17 17
Device Contamination with Chemical or Other Material 15 15
Failure to Sense 14 15
Packaging Problem 13 13
Electrical Shorting 12 12
Contamination 12 12
Use of Device Problem 12 12
Appropriate Term/Code Not Available 11 11
Material Puncture/Hole 10 10
Connection Problem 10 10
Output Problem 9 9
Physical Resistance/Sticking 9 9
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Material Split, Cut or Torn 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1733 1735
Cardiac Tamponade 477 477
Pericardial Effusion 318 318
Cardiac Perforation 221 222
Low Blood Pressure/ Hypotension 193 193
Stroke/CVA 101 101
Heart Block 84 84
Insufficient Information 77 77
Hemorrhage/Bleeding 60 60
Cardiac Arrest 54 54
Fistula 52 52
Hematoma 44 44
Pseudoaneurysm 42 42
Thrombosis/Thrombus 41 41
Arrhythmia 40 40
Tachycardia 40 40
Unspecified Tissue Injury 33 33
Non specific EKG/ECG Changes 32 32
Foreign Body In Patient 31 32
Chest Pain 29 29
Transient Ischemic Attack 28 28
Perforation 28 28
Air Embolism 23 23
Bradycardia 23 24
Hemoptysis 23 23
Atrial Fibrillation 21 21
Ischemia Stroke 21 21
Embolism/Embolus 20 21
Vascular Dissection 19 19
Pericarditis 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Atrial Flutter 15 15
Nerve Damage 15 15
Heart Failure/Congestive Heart Failure 13 13
Perforation of Vessels 13 13
Ventricular Fibrillation 13 13
Myocardial Infarction 13 13
Mitral Valve Insufficiency/ Regurgitation 12 12
Pulmonary Valve Stenosis 12 12
Inflammation 12 12
Paralysis 12 12
Rupture 12 12
Sepsis 10 10
Dyspnea 9 9
Pulmonary Embolism 8 8
Pneumonia 8 8
Physical Entrapment 8 8
Asystole 8 8
Fever 8 8
Hypoxia 8 8

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