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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device permanent defibrillator electrodes
Definition Permanent defibrillator electrodes are used with compatible implantable cardioverter defibrillators (ICD) and cardiac rhythm therapy-defibrillators (CRT-D) to sense the cardiac rhythm and to deliver high energy therapy to the heart when tachycardia is detected. Some transvenous models can also be used for pacing the right ventricle.
Product CodeNVY
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
12 10 12 12 9 8

MDR Year MDR Reports MDR Events
2021 8060 8067
2022 7638 7655
2023 10442 10461
2024 9366 9391
2025 11640 11641
2026 5784 5785

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 12784 12812
High impedance 12026 12040
Adverse Event Without Identified Device or Use Problem 7769 7774
Device Dislodged or Dislocated 4772 4779
Signal Artifact/Noise 4294 4305
Failure to Capture 4089 4094
Inappropriate/Inadequate Shock/Stimulation 3639 3644
Capturing Problem 3615 3620
Fracture 3046 3048
Low impedance 2756 2758
Device Sensing Problem 2545 2548
Ambient Noise Problem 2519 2519
Break 2389 2395
High Capture Threshold 2310 2313
Impedance Problem 2116 2119
Under-Sensing 1693 1693
Pacing Problem 1136 1141
Difficult to Fold, Unfold or Collapse 1040 1040
Insufficient Device Problem Information 961 962
Defective Device 884 895
Decreased Sensitivity 609 610
Naturally Worn 594 594
Failure to Sense 517 517
Use of Device Problem 514 515
Retraction Problem 493 493
Failure to Read Input Signal 457 457
Failure to Convert Rhythm 349 351
Intermittent Capture 274 274
Therapy Delivered to Incorrect Body Area 261 261
No Apparent Adverse Event 260 262
Material Integrity Problem 250 250
Positioning Problem 245 247
Failure to Deliver Shock/Stimulation 211 211
Failure to Advance 198 198
Mechanical Problem 192 193
Appropriate Device Problem Term/Code Not Available 180 181
Material Twisted/Bent 174 174
Unstable Capture Threshold 161 161
Nonstandard Device 151 151
Difficult to Remove 130 131
Therapeutic or Diagnostic Output Failure 108 108
Connection Problem 96 96
Charging Problem 92 92
Failure to Disconnect 89 89
Defibrillation/Stimulation Problem 89 89
Detachment of Device or Device Component 81 81
Unexpected Therapeutic Results 69 69
No Pacing 61 61
Product Quality Problem 53 53
Activation, Positioning or Separation Problem 51 51

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 36572 36626
Unspecified Infection 6642 6645
Insufficient Information 2715 2719
Shock from Patient Lead(s) 2358 2359
Discomfort 1107 1109
Cardiac Perforation 738 739
Arrhythmia 596 597
Sepsis 496 496
Pocket Erosion 368 368
Syncope/Fainting 354 354
Electric Shock 289 292
Dizziness 262 262
Failure of Implant 245 245
Bacterial Infection 244 244
Pericardial Effusion 222 224
Ventricular Fibrillation 185 185
Asystole 179 179
Twiddlers Syndrome 175 176
Perforation 170 170
Dyspnea 153 153
No Code Available 152 152
Endocarditis 149 149
Pain 148 148
Erosion 131 131
Chest Pain 128 128
Calcium Deposits/Calcification 127 127
Bradycardia 124 124
Swelling/ Edema 117 117
Fever 116 116
No Consequences Or Impact To Patient 114 114
Wound Dehiscence 113 113
Erythema 113 113
Tachycardia 104 105
Purulent Discharge 98 98
Foreign Body In Patient 96 96
Low Blood Pressure/ Hypotension 96 98
Bacteremia 95 95
Device Overstimulation of Tissue 93 95
Cardiac Arrest 85 85
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 79 80
Hematoma 77 77
Cardiac Tamponade 70 70
Heart Failure/Congestive Heart Failure 69 69
No Known Impact Or Consequence To Patient 69 69
Fatigue 69 69
Fall 62 62
Medical device site infection 53 53
Valvular Insufficiency/ Regurgitation 53 53
Obstruction/Occlusion 49 50
Fluid Discharge 48 48

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation I Aug-20-2025
2 Boston Scientific Corporation II Oct-31-2022
3 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Dec-16-2021
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