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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 3

MDR Year MDR Reports MDR Events
2021 8058 8065
2022 7636 7653
2023 10441 10460
2024 9364 9389
2025 11638 11639
2026 1810 1810

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 11820 11848
High impedance 11141 11155
Adverse Event Without Identified Device or Use Problem 7229 7233
Device Dislodged or Dislocated 4409 4416
Signal Artifact/Noise 3924 3935
Failure to Capture 3851 3856
Capturing Problem 3460 3465
Inappropriate/Inadequate Shock/Stimulation 3390 3395
Fracture 2853 2855
Low impedance 2619 2621
Device Sensing Problem 2419 2422
Ambient Noise Problem 2326 2326
Break 2272 2278
High Capture Threshold 2121 2124
Impedance Problem 2016 2019
Under-Sensing 1550 1550
Pacing Problem 1035 1040
Difficult to Fold, Unfold or Collapse 973 973
Defective Device 896 907
Insufficient Information 850 851
Naturally Worn 580 580
Decreased Sensitivity 515 516
Failure to Sense 497 497
Use of Device Problem 490 491
Retraction Problem 468 468
Failure to Read Input Signal 395 395
Failure to Convert Rhythm 312 314
Intermittent Capture 256 256
Therapy Delivered to Incorrect Body Area 248 248
No Apparent Adverse Event 232 234
Failure to Deliver Shock/Stimulation 201 201
Material Integrity Problem 200 200
Failure to Advance 194 194
Positioning Problem 188 190
Mechanical Problem 161 162
Appropriate Term/Code Not Available 154 155
Material Twisted/Bent 149 149
Nonstandard Device 146 146
Unstable Capture Threshold 146 146
Therapeutic or Diagnostic Output Failure 122 122
Difficult to Remove 117 118
Connection Problem 91 91
Charging Problem 84 84
Output Problem 82 82
Failure to Disconnect 82 82
Defibrillation/Stimulation Problem 75 75
Detachment of Device or Device Component 63 63
No Pacing 62 62
Unexpected Therapeutic Results 58 58
Product Quality Problem 53 53

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33656 33710
Unspecified Infection 6191 6193
Insufficient Information 2635 2639
Shock from Patient Lead(s) 2130 2131
Discomfort 1025 1027
Cardiac Perforation 700 701
Arrhythmia 567 568
Sepsis 477 477
Pocket Erosion 341 341
Syncope/Fainting 328 328
Electric Shock 285 288
Dizziness 243 243
Failure of Implant 234 234
Bacterial Infection 226 226
Pericardial Effusion 195 197
Asystole 161 161
Ventricular Fibrillation 158 158
Twiddlers Syndrome 156 157
No Code Available 152 152
Perforation 146 146
Dyspnea 138 138
Endocarditis 138 138
Pain 128 128
Erosion 114 114
No Consequences Or Impact To Patient 114 114
Chest Pain 111 111
Bradycardia 109 109
Calcium Deposits/Calcification 108 108
Fever 102 102
Swelling/ Edema 100 100
Erythema 99 99
Wound Dehiscence 99 99
Foreign Body In Patient 89 89
Low Blood Pressure/ Hypotension 88 90
Tachycardia 87 88
Purulent Discharge 83 83
Device Overstimulation of Tissue 83 85
Cardiac Arrest 78 78
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 75 76
Hematoma 71 71
No Known Impact Or Consequence To Patient 69 69
Fatigue 67 67
Cardiac Tamponade 65 65
Heart Failure/Congestive Heart Failure 63 63
Fall 51 51
Obstruction/Occlusion 47 48
Valvular Insufficiency/ Regurgitation 47 47
Fluid Discharge 41 41
Pneumothorax 38 39
Atrial Fibrillation 38 38

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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