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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 left ventricular (lv) pacemaker electrode
Definition Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart.
Product CodeOJX
Device Class 3

Premarket Approvals (PMA)
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
16 11 27 19 24 21 19 19 9 11 0

MDR Year MDR Reports MDR Events
2014 3004 3004
2015 3724 3724
2016 3030 3030
2017 3294 3294
2018 3979 3979
2019 3926 3926
2020 2776 2776
2021 2869 2869
2022 2947 2947
2023 4469 4469
2024 929 929

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8777 8777
Device Dislodged or Dislocated 8442 8442
High Capture Threshold 6203 6203
Failure to Capture 5079 5079
High impedance 2556 2556
Capturing Problem 1821 1821
Appropriate Term/Code Not Available 1449 1449
Activation, Positioning or Separation Problem 1407 1407
Positioning Problem 1174 1174
Break 884 884
Low impedance 827 827
Impedance Problem 809 809
Fracture 735 735
Difficult to Insert 468 468
Unstable Capture Threshold 440 440
Difficult to Remove 417 417
Intermittent Capture 402 402
Over-Sensing 339 339
Insufficient Information 323 323
Pacing Problem 300 300
Material Integrity Problem 264 264
Device Operates Differently Than Expected 180 180
Ambient Noise Problem 171 171
Signal Artifact/Noise 168 168
Device Sensing Problem 139 139
Therapy Delivered to Incorrect Body Area 124 124
Pocket Stimulation 116 116
Failure to Sense 106 106
Failure to Advance 105 105
Separation Failure 102 102
Difficult To Position 92 92
Connection Problem 88 88
Mechanical Problem 86 86
Therapeutic or Diagnostic Output Failure 77 77
Device Contamination with Body Fluid 75 75
Inappropriate/Inadequate Shock/Stimulation 75 75
Use of Device Problem 71 71
Electrical /Electronic Property Problem 65 65
High Sensing Threshold 62 62
No Pacing 60 60
Accessory Incompatible 59 59
Device Handling Problem 56 56
Under-Sensing 55 55
Defective Device 54 54
Stretched 49 49
Improper or Incorrect Procedure or Method 48 48
Difficult to Advance 43 43
Difficult or Delayed Positioning 35 35
Positioning Failure 35 35
Pacing Inadequately 30 30
Detachment of Device or Device Component 29 29
Material Twisted/Bent 29 29
Output Problem 25 25
Malposition of Device 25 25
Retraction Problem 25 25
Cut In Material 24 24
Material Separation 21 21
Material Deformation 21 21
Failure to Disconnect 20 20
Kinked 19 19
Loose or Intermittent Connection 18 18
Migration or Expulsion of Device 18 18
Nonstandard Device 18 18
Patient-Device Incompatibility 18 18
Product Quality Problem 18 18
Device Contamination with Chemical or Other Material 17 17
Device Damaged by Another Device 16 16
Detachment Of Device Component 15 15
Bent 14 14
Defective Component 14 14
Migration 14 14
Material Split, Cut or Torn 14 14
Structural Problem 13 13
Deformation Due to Compressive Stress 12 12
Naturally Worn 12 12
Human-Device Interface Problem 11 11
Device-Device Incompatibility 11 11
Shelf Life Exceeded 10 10
Defibrillation/Stimulation Problem 9 9
Component Missing 9 9
Collapse 9 9
Physical Resistance/Sticking 9 9
Patient Device Interaction Problem 8 8
Partial Blockage 8 8
Material Erosion 8 8
Misconnection 8 8
Material Puncture/Hole 8 8
Low Sensing Threshold 8 8
Inadequacy of Device Shape and/or Size 7 7
Loss of Threshold 7 7
Electromagnetic Interference 7 7
Premature Discharge of Battery 7 7
Complete Blockage 7 7
No Apparent Adverse Event 7 7
Programming Issue 6 6
Contamination 6 6
Entrapment of Device 6 6
Device Expiration Issue 6 6
Difficult to Flush 6 6
Degraded 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13673 13673
No Clinical Signs, Symptoms or Conditions 6672 6672
Unspecified Infection 4267 4267
Muscle Stimulation 2100 2100
Undesired Nerve Stimulation 1969 1969
Death 1284 1284
No Consequences Or Impact To Patient 957 957
Device Overstimulation of Tissue 728 728
Insufficient Information 726 726
Dyspnea 448 448
No Code Available 302 302
Sepsis 298 298
Discomfort 272 272
Twiddlers Syndrome 269 269
Endocarditis 248 248
Pericardial Effusion 224 224
Pocket Erosion 219 219
Vascular Dissection 209 209
Erosion 197 197
Chest Pain 196 196
Fatigue 162 162
Pain 152 152
Dizziness 148 148
Bacterial Infection 147 147
Hematoma 138 138
Erythema 126 126
Heart Failure 124 124
Fever 123 123
Complaint, Ill-Defined 121 121
Wound Dehiscence 118 118
Cardiac Arrest 117 117
Cardiac Tamponade 99 99
Fall 98 98
Pneumothorax 97 97
Cardiac Perforation 92 92
Swelling/ Edema 92 92
Arrhythmia 84 84
Syncope/Fainting 83 83
Swelling 80 80
Syncope 79 79
Purulent Discharge 69 69
Low Blood Pressure/ Hypotension 69 69
Ventricular Fibrillation 68 68
Congestive Heart Failure 65 65
Failure of Implant 64 64
Hiccups 61 61
Exit Block 61 61
Twitching 61 61
Palpitations 60 60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 59 59
Heart Failure/Congestive Heart Failure 58 58
Ventricular Tachycardia 56 56
Thrombosis 55 55
Twiddlers Syndrome 55 55
Pleural Effusion 54 54
Perforation 53 53
Bradycardia 53 53
Septic Shock 49 49
Tachycardia 48 48
Atrial Fibrillation 47 47
Shock from Patient Lead(s) 45 45
Obstruction/Occlusion 42 42
Weakness 42 42
Occlusion 40 40
Perforation of Vessels 37 37
Thrombosis/Thrombus 37 37
Fluid Discharge 36 36
Drug Resistant Bacterial Infection 36 36
No Information 35 35
Impaired Healing 31 31
Inflammation 31 31
Nausea 31 31
Muscle Weakness 30 30
Thrombus 30 30
Chills 26 26
Cardiomyopathy 23 23
Pneumonia 22 22
Vomiting 20 20
Cardiogenic Shock 20 20
Stenosis 19 19
Foreign Body In Patient 19 19
Asystole 19 19
Renal Failure 19 19
Hypersensitivity/Allergic reaction 17 17
Edema 17 17
Heart Block 17 17
Cardiopulmonary Arrest 16 16
Pulmonary Edema 16 16
Myocardial Infarction 15 15
Non specific EKG/ECG Changes 15 15
Malaise 15 15
Sleep Dysfunction 15 15
Loss of consciousness 14 14
Respiratory Failure 14 14
Necrosis 14 14
Muscle Spasm(s) 14 14
Staphylococcus Aureus 14 14
Pulmonary Embolism 13 13
Presyncope 13 13
Lethargy 12 12

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