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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)
2020 2021 2022 2023 2024 2025
13 12 10 12 12 0

MDR Year MDR Reports MDR Events
2020 8018 8018
2021 8056 8056
2022 7628 7628
2023 10438 10438
2024 9358 9358
2025 877 877

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 11077 11077
High impedance 8737 8737
Adverse Event Without Identified Device or Use Problem 6910 6910
Device Dislodged or Dislocated 4220 4220
Signal Artifact/Noise 4190 4190
Failure to Capture 3720 3720
Inappropriate/Inadequate Shock/Stimulation 3256 3256
Capturing Problem 2977 2977
Fracture 2608 2608
Break 2436 2436
High Capture Threshold 2427 2427
Low impedance 2407 2407
Ambient Noise Problem 2193 2193
Device Sensing Problem 2179 2179
Impedance Problem 1750 1750
Under-Sensing 1309 1309
Pacing Problem 842 842
Difficult to Fold, Unfold or Collapse 810 810
Defective Device 711 711
Insufficient Information 648 648
Naturally Worn 565 565
Failure to Sense 527 527
Retraction Problem 447 447
Decreased Sensitivity 429 429
Use of Device Problem 416 416
Failure to Read Input Signal 247 247
Failure to Convert Rhythm 242 242
Intermittent Capture 241 241
Therapy Delivered to Incorrect Body Area 219 219
No Apparent Adverse Event 207 207
Failure to Deliver Shock/Stimulation 199 199
Low Sensing Threshold 195 195
Failure to Advance 175 175
Unstable Capture Threshold 145 145
Material Integrity Problem 143 143
Nonstandard Device 134 134
Material Twisted/Bent 134 134
Appropriate Term/Code Not Available 129 129
Positioning Problem 116 116
Therapeutic or Diagnostic Output Failure 115 115
Difficult to Remove 113 113
Mechanical Problem 96 96
No Pacing 85 85
Connection Problem 77 77
Failure to Disconnect 68 68
Difficult to Insert 68 68
Charging Problem 63 63
Detachment of Device or Device Component 58 58
Positioning Failure 52 52
Activation, Positioning or Separation Problem 52 52

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25109 25109
Unspecified Infection 5826 5826
No Known Impact Or Consequence To Patient 3521 3521
Insufficient Information 2306 2306
Shock from Patient Lead(s) 2055 2055
No Consequences Or Impact To Patient 1349 1349
Discomfort 914 914
Cardiac Perforation 696 696
No Code Available 685 685
Sepsis 630 630
Arrhythmia 487 487
Pocket Erosion 346 346
Electric Shock 291 291
Syncope/Fainting 281 281
Therapeutic Effects, Unexpected 266 266
Dizziness 227 227
Bacterial Infection 201 201
Failure of Implant 193 193
Pericardial Effusion 184 184
Endocarditis 154 154
Dyspnea 152 152
Death 146 146
Ventricular Fibrillation 144 144
Asystole 119 119
Twiddlers Syndrome 117 117
Twiddlers Syndrome 106 106
Pain 105 105
Bradycardia 104 104
Erosion 101 101
Fever 98 98
No Information 89 89
Chest Pain 89 89
Perforation 86 86
Low Blood Pressure/ Hypotension 85 85
Foreign Body In Patient 78 78
Tachycardia 72 72
Cardiac Arrest 72 72
Device Overstimulation of Tissue 70 70
Wound Dehiscence 70 70
Swelling/ Edema 70 70
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 69 69
Fatigue 68 68
Hematoma 64 64
Erythema 64 64
Fall 61 61
Purulent Discharge 61 61
Cardiac Tamponade 58 58
Undesired Nerve Stimulation 56 56
Muscle Stimulation 52 52
Heart Failure/Congestive Heart Failure 49 49

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