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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)
2019 2020 2021 2022 2023 2024
15 13 12 10 12 2

MDR Year MDR Reports MDR Events
2019 8321 8321
2020 8018 8018
2021 8054 8054
2022 7627 7627
2023 10436 10436
2024 2974 2974

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 11151 11151
High impedance 8643 8643
Adverse Event Without Identified Device or Use Problem 7405 7405
Signal Artifact/Noise 4864 4864
Device Dislodged or Dislocated 4480 4480
Failure to Capture 3790 3790
Inappropriate/Inadequate Shock/Stimulation 3490 3490
High Capture Threshold 3154 3154
Break 2666 2666
Fracture 2608 2608
Capturing Problem 2601 2601
Low impedance 2438 2438
Ambient Noise Problem 2183 2183
Device Sensing Problem 2126 2126
Impedance Problem 1729 1729
Under-Sensing 1241 1241
Pacing Problem 752 752
Difficult to Fold, Unfold or Collapse 703 703
Insufficient Information 622 622
Defective Device 594 594
Naturally Worn 529 529
Failure to Sense 516 516
Retraction Problem 443 443
Decreased Sensitivity 433 433
Low Sensing Threshold 374 374
Use of Device Problem 358 358
Intermittent Capture 269 269
Material Integrity Problem 238 238
Failure to Deliver Shock/Stimulation 218 218
Failure to Convert Rhythm 213 213
Therapy Delivered to Incorrect Body Area 186 186
Failure to Read Input Signal 171 171
No Apparent Adverse Event 170 170
Appropriate Term/Code Not Available 161 161
Failure to Advance 150 150
Unstable Capture Threshold 143 143
Nonstandard Device 135 135
Material Twisted/Bent 134 134
Therapeutic or Diagnostic Output Failure 120 120
No Pacing 116 116
Difficult to Remove 110 110
Positioning Problem 109 109
Difficult to Insert 103 103
Mechanical Problem 101 101
Connection Problem 77 77
Positioning Failure 74 74
Failure to Disconnect 64 64
Activation, Positioning or Separation Problem 61 61
High Sensing Threshold 58 58
Failure to Select Signal 56 56
Charging Problem 55 55
Pocket Stimulation 53 53
Defibrillation/Stimulation Problem 51 51
Detachment of Device or Device Component 51 51
Product Quality Problem 50 50
Patient-Device Incompatibility 45 45
Unexpected Therapeutic Results 43 43
Output Problem 42 42
Electrical /Electronic Property Problem 37 37
Incorrect Interpretation of Signal 35 35
Defective Component 34 34
Sensing Intermittently 33 33
Migration 33 33
Pacing Intermittently 31 31
Loose or Intermittent Connection 30 30
Protective Measures Problem 28 28
Electromagnetic Interference 24 24
Separation Failure 24 24
Pacing Inadequately 20 20
Energy Output Problem 20 20
Malposition of Device 19 19
Noise, Audible 18 18
Contamination of Device Ingredient or Reagent 17 17
Off-Label Use 17 17
Degraded 17 17
Collapse 14 14
Pacemaker Found in Back-Up Mode 13 13
Device Contamination with Body Fluid 12 12
Device Displays Incorrect Message 11 11
Migration or Expulsion of Device 11 11
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Display or Visual Feedback Problem 10 10
Material Deformation 10 10
Stretched 9 9
Improper or Incorrect Procedure or Method 9 9
Incorrect Measurement 8 8
Accessory Incompatible 8 8
Patient Device Interaction Problem 8 8
Pacing Asynchronously 7 7
Loss of Threshold 7 7
Device-Device Incompatibility 7 7
Difficult to Advance 7 7
Device Contamination with Chemical or Other Material 7 7
Contamination /Decontamination Problem 6 6
Output below Specifications 6 6
Battery Problem 6 6
Device Alarm System 6 6
Data Problem 6 6
Material Split, Cut or Torn 6 6
Misassembled 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20072 20072
No Known Impact Or Consequence To Patient 8703 8703
Unspecified Infection 6008 6008
Shock from Patient Lead(s) 2299 2299
Insufficient Information 2165 2165
No Consequences Or Impact To Patient 1569 1569
Discomfort 849 849
Sepsis 815 815
Cardiac Perforation 728 728
No Code Available 721 721
Therapeutic Effects, Unexpected 599 599
Arrhythmia 415 415
Pocket Erosion 370 370
Death 353 353
Electric Shock 276 276
Dizziness 236 236
Syncope/Fainting 235 235
Twiddlers Syndrome 219 219
Pericardial Effusion 206 206
No Information 194 194
Bacterial Infection 177 177
Endocarditis 169 169
Ventricular Fibrillation 165 165
Dyspnea 149 149
Failure of Implant 121 121
Chest Pain 109 109
Syncope 108 108
Muscle Stimulation 105 105
Fever 105 105
Perforation 105 105
Pain 103 103
Erosion 97 97
Bradycardia 94 94
Low Blood Pressure/ Hypotension 92 92
Twiddlers Syndrome 83 83
Asystole 78 78
Hematoma 76 76
Cardiac Arrest 75 75
Undesired Nerve Stimulation 70 70
Fall 68 68
Foreign Body In Patient 68 68
Wound Dehiscence 67 67
Fatigue 66 66
Tachycardia 65 65
Cardiac Tamponade 64 64
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 57 57
Device Overstimulation of Tissue 54 54
Ventricular Tachycardia 53 53
Swelling/ Edema 46 46
Heart Failure/Congestive Heart Failure 43 43
Purulent Discharge 43 43
Staphylococcus Aureus 41 41
Pneumothorax 37 37
Erythema 36 36
Swelling 33 33
Atrial Fibrillation 32 32
Obstruction/Occlusion 31 31
Complaint, Ill-Defined 30 30
Vascular Dissection 28 28
Fluid Discharge 24 24
Thrombosis/Thrombus 22 22
Calcium Deposits/Calcification 21 21
No Patient Involvement 19 19
Hemorrhage/Bleeding 18 18
Hypersensitivity/Allergic reaction 17 17
Palpitations 17 17
Presyncope 16 16
Inflammation 16 16
Pleural Effusion 16 16
Septic Shock 15 15
Abscess 15 15
Valvular Insufficiency/ Regurgitation 15 15
Occlusion 13 13
Impaired Healing 13 13
Non specific EKG/ECG Changes 11 11
Drug Resistant Bacterial Infection 11 11
Complete Heart Block 11 11
Stroke/CVA 10 10
Muscle Weakness 10 10
Perforation of Vessels 10 10
Cardiogenic Shock 10 10
Heart Failure 9 9
Nausea 9 9
Pulmonary Embolism 9 9
Congestive Heart Failure 8 8
Edema 8 8
Necrosis 8 8
High Blood Pressure/ Hypertension 8 8
Vomiting 8 8
Thrombosis 8 8
Exit Block 8 8
Heart Block 8 8
Embolism/Embolus 8 8
Tricuspid Valve Insufficiency/ Regurgitation 7 7
Implant Pain 7 7
Discharge 7 7
Chills 7 7
Loss of consciousness 7 7
Anxiety 7 7
Cellulitis 7 7

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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