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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Definition Drug eluting permanent RV or RA pacemaker electrodes are used with compatible pacemakers or implantable cardioverter defibrillators (ICD) or cardiac rhythm therapy (CRT) devices to deliver pacing pulses to the heart.
Product CodeNVN
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
10 10 11 19 7 5 10 62 67 86 56 69 60 43 38 8

MDR Year MDR Reports MDR Events
2014 9885 9885
2015 10137 10137
2016 9391 9391
2017 11614 11614
2018 11519 11519
2019 16872 16872
2020 16529 16529
2021 17756 17756
2022 18200 18200
2023 24999 24999
2024 9369 9369

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 30159 30159
Adverse Event Without Identified Device or Use Problem 28489 28489
Device Dislodged or Dislocated 24148 24148
Failure to Capture 18353 18353
High Capture Threshold 18213 18213
Signal Artifact/Noise 17000 17000
High impedance 13579 13579
Break 8796 8796
Low impedance 8301 8301
Capturing Problem 7013 7013
Under-Sensing 6817 6817
Fracture 6570 6570
Pacing Problem 5978 5978
Device Sensing Problem 5066 5066
Failure to Sense 3537 3537
Impedance Problem 3395 3395
Material Integrity Problem 3034 3034
Ambient Noise Problem 2661 2661
Mechanical Problem 2417 2417
Insufficient Information 2389 2389
Positioning Problem 2270 2270
Defective Device 1853 1853
Intermittent Capture 1819 1819
Difficult to Fold, Unfold or Collapse 1369 1369
Decreased Sensitivity 1260 1260
Appropriate Term/Code Not Available 1123 1123
Unstable Capture Threshold 1071 1071
Difficult to Insert 988 988
Retraction Problem 971 971
No Apparent Adverse Event 965 965
Use of Device Problem 898 898
Device Operates Differently Than Expected 789 789
Failure to Read Input Signal 752 752
Material Twisted/Bent 623 623
Difficult to Remove 558 558
Electrical /Electronic Property Problem 519 519
Therapy Delivered to Incorrect Body Area 500 500
Failure to Advance 484 484
Low Sensing Threshold 465 465
Off-Label Use 423 423
No Pacing 412 412
Activation, Positioning or Separation Problem 388 388
Positioning Failure 378 378
Difficult To Position 358 358
Connection Problem 340 340
Human-Device Interface Problem 326 326
Pocket Stimulation 285 285
Pacing Intermittently 272 272
Failure to Disconnect 263 263
Sensing Intermittently 237 237
Inappropriate/Inadequate Shock/Stimulation 231 231
Naturally Worn 227 227
High Sensing Threshold 197 197
Therapeutic or Diagnostic Output Failure 176 176
Stretched 156 156
Patient-Device Incompatibility 148 148
Failure to Select Signal 140 140
Defective Component 134 134
Invalid Sensing 134 134
Bent 130 130
Product Quality Problem 118 118
Migration 117 117
Degraded 116 116
Output Problem 113 113
Pacemaker Found in Back-Up Mode 108 108
Structural Problem 107 107
Detachment of Device or Device Component 103 103
Electromagnetic Interference 88 88
Noise, Audible 87 87
Electronic Property Issue 81 81
Contamination /Decontamination Problem 79 79
Separation Failure 78 78
Loose or Intermittent Connection 78 78
Device Abrasion From Instrument Or Another Object 72 72
Kinked 69 69
Contamination of Device Ingredient or Reagent 69 69
Device Contamination with Chemical or Other Material 68 68
Difficult to Advance 67 67
Material Deformation 61 61
Device-Device Incompatibility 60 60
Device Contamination with Body Fluid 58 58
Malposition of Device 57 57
Pacing Inadequately 56 56
Migration or Expulsion of Device 56 56
Accessory Incompatible 56 56
Collapse 51 51
Unexpected Therapeutic Results 49 49
Difficult or Delayed Positioning 48 48
Material Split, Cut or Torn 48 48
Device Handling Problem 44 44
Device Contaminated at the User Facility 42 42
Device Contamination With Biological Material 41 41
Device Damaged by Another Device 39 39
Improper or Incorrect Procedure or Method 38 38
Deformation Due to Compressive Stress 36 36
Material Erosion 33 33
Patient Device Interaction Problem 30 30
Cut In Material 28 28
Pacing Asynchronously 28 28
Material Separation 28 28

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 54741 54741
No Clinical Signs, Symptoms or Conditions 48454 48454
Unspecified Infection 18766 18767
No Consequences Or Impact To Patient 6376 6376
Insufficient Information 3643 3643
Death 3356 3356
No Code Available 3311 3311
Sepsis 2474 2474
Cardiac Perforation 2459 2459
Dizziness 2356 2356
Discomfort 1538 1538
Pocket Erosion 1334 1334
Syncope 1205 1205
Pericardial Effusion 1181 1181
Bradycardia 1101 1101
Muscle Stimulation 1074 1074
Dyspnea 989 989
Arrhythmia 967 967
Syncope/Fainting 945 945
Chest Pain 922 922
No Information 905 905
Twiddlers Syndrome 871 872
Perforation 807 807
Pain 677 677
Fatigue 604 604
Bacterial Infection 575 575
Endocarditis 535 535
Cardiac Arrest 499 499
Undesired Nerve Stimulation 437 437
Fall 436 436
Cardiac Tamponade 387 387
Complaint, Ill-Defined 375 375
Hematoma 345 345
Erosion 340 340
Twiddlers Syndrome 337 337
Asystole 332 332
Fever 304 304
Failure of Implant 294 294
Device Overstimulation of Tissue 290 290
Pneumothorax 261 261
Wound Dehiscence 261 261
Palpitations 261 262
Atrial Fibrillation 253 253
Low Blood Pressure/ Hypotension 235 235
Tachycardia 234 234
Foreign Body In Patient 205 205
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 199 199
Shock from Patient Lead(s) 198 198
Purulent Discharge 176 176
Swelling/ Edema 173 173
Exit Block 153 153
Heart Block 152 152
Staphylococcus Aureus 149 149
Pleural Effusion 141 141
Complete Heart Block 128 128
Heart Failure/Congestive Heart Failure 127 127
Swelling 124 124
Erythema 120 120
Presyncope 118 118
Obstruction/Occlusion 111 111
Inflammation 110 110
Ventricular Fibrillation 107 107
Hypersensitivity/Allergic reaction 103 103
Fainting 103 103
Ventricular Tachycardia 102 102
Atrial Perforation 100 100
Non specific EKG/ECG Changes 100 100
Congestive Heart Failure 93 93
Hemorrhage/Bleeding 93 93
Fluid Discharge 92 92
Weakness 88 88
Heart Failure 84 84
Occlusion 82 82
Loss of consciousness 73 73
Septic Shock 70 70
Thrombosis/Thrombus 68 68
Therapeutic Effects, Unexpected 66 66
Impaired Healing 65 65
Vascular Dissection 62 62
No Patient Involvement 60 60
Nausea 60 60
Thrombosis 55 55
Muscle Weakness 51 51
Unspecified Heart Problem 50 50
High Blood Pressure/ Hypertension 47 47
Perforation of Vessels 46 46
Valvular Insufficiency/ Regurgitation 46 46
Cardiopulmonary Arrest 45 45
Respiratory Failure 43 43
Patient Problem/Medical Problem 43 43
Tricuspid Regurgitation 42 42
Vomiting 42 42
Stroke/CVA 42 42
Cardiomyopathy 41 41
Tricuspid Valve Insufficiency/ Regurgitation 41 41
Atrial Flutter 38 38
Twitching 38 38
Thrombus 37 37
Implant Pain 37 37
Hemothorax 36 36

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