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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)
2020 2021 2022 2023 2024 2025
19 19 9 11 7 5

MDR Year MDR Reports MDR Events
2020 2776 2776
2021 2869 2873
2022 2947 2962
2023 4468 4482
2024 3395 3399
2025 3160 3160

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5952 5961
High Capture Threshold 3822 3826
Device Dislodged or Dislocated 3065 3071
Failure to Capture 2563 2565
High impedance 1613 1615
Capturing Problem 1581 1586
Impedance Problem 776 777
Activation, Positioning or Separation Problem 662 662
Positioning Problem 592 593
Low impedance 567 568
Fracture 408 408
Unstable Capture Threshold 406 406
Break 360 361
Appropriate Term/Code Not Available 351 357
Insufficient Information 284 286
Intermittent Capture 273 274
Material Integrity Problem 223 223
Pacing Problem 215 216
Over-Sensing 186 187
Ambient Noise Problem 184 184
Therapy Delivered to Incorrect Body Area 143 144
Signal Artifact/Noise 106 106
Device Sensing Problem 90 90
Failure to Advance 88 88
Pocket Stimulation 84 84
Use of Device Problem 83 83
Therapeutic or Diagnostic Output Failure 82 82
Difficult to Remove 68 69
Electrical /Electronic Property Problem 61 61
Inappropriate/Inadequate Shock/Stimulation 60 61
Stretched 59 59
Failure to Sense 44 44
Device Contamination with Body Fluid 42 42
Mechanical Problem 39 39
Defective Device 38 38
Separation Failure 36 36
Under-Sensing 36 37
Connection Problem 32 32
No Pacing 32 32
Output Problem 31 31
Material Twisted/Bent 26 26
High Sensing Threshold 26 26
Improper or Incorrect Procedure or Method 26 26
Device Handling Problem 24 24
Difficult to Insert 23 23
Detachment of Device or Device Component 22 22
Accessory Incompatible 20 20
Product Quality Problem 16 16
Patient Device Interaction Problem 16 16
Failure to Disconnect 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9907 9932
Unspecified Infection 3533 3534
Undesired Nerve Stimulation 996 996
Device Overstimulation of Tissue 947 949
Insufficient Information 806 808
No Known Impact Or Consequence To Patient 743 743
No Consequences Or Impact To Patient 721 721
Discomfort 343 344
Erythema 267 267
Dyspnea 247 248
Sepsis 244 244
Bacterial Infection 235 236
Erosion 231 231
Pocket Erosion 229 229
Swelling/ Edema 197 198
Muscle Stimulation 182 182
Purulent Discharge 177 177
Endocarditis 158 158
Pain 157 157
Fever 154 154
Wound Dehiscence 140 140
Chest Pain 139 139
Dizziness 107 107
Pericardial Effusion 106 107
Syncope/Fainting 105 106
Arrhythmia 101 101
Failure of Implant 95 95
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 90 91
Heart Failure/Congestive Heart Failure 89 89
Twiddlers Syndrome 83 83
Drug Resistant Bacterial Infection 81 81
Hematoma 73 73
Fatigue 72 72
Vascular Dissection 67 67
Obstruction/Occlusion 63 64
Fall 60 60
Twitching 58 58
Fluid Discharge 55 55
Tachycardia 48 48
Death 48 48
Low Blood Pressure/ Hypotension 47 48
Thrombosis/Thrombus 47 48
Bradycardia 47 47
Cardiac Arrest 42 43
Muscle Weakness 41 41
Septic Shock 39 39
Cardiac Perforation 39 39
Cardiac Tamponade 39 39
Hiccups 37 37
Asystole 30 30

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