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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 right ventricular (rv) or right atrial (ra) pacemaker electrodes
Definition Drug eluting permanent RV or RA pacemaker electrodes are used with compatible pacemakers or implantable cardioverter defibrillators (ICD) or cardiac rhythm therapy (CRT) devices to deliver pacing pulses to the heart.
Product CodeNVN
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
86 56 69 60 43 4

MDR Year MDR Reports MDR Events
2018 11519 11519
2019 16874 16874
2020 16530 16530
2021 17760 17760
2022 18207 18207
2023 2872 2872

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 17259 17259
Over-Sensing 15136 15136
Signal Artifact/Noise 13435 13435
Device Dislodged or Dislocated 12766 12766
High Capture Threshold 10275 10275
Failure to Capture 9732 9732
High impedance 7395 7395
Break 5039 5039
Low impedance 4283 4283
Capturing Problem 3690 3690
Pacing Problem 3513 3513
Under-Sensing 3313 3313
Fracture 3292 3292
Device Sensing Problem 2749 2749
Failure to Sense 1820 1820
Mechanical Problem 1817 1817
Positioning Problem 1528 1528
Material Integrity Problem 1458 1458
Impedance Problem 1405 1405
Defective Device 1280 1280
Ambient Noise Problem 1276 1276
Insufficient Information 916 916
Intermittent Capture 915 915
Difficult to Fold, Unfold or Collapse 799 799
Decreased Sensitivity 717 717
Appropriate Term/Code Not Available 650 650
Retraction Problem 613 613
Use of Device Problem 573 573
Unstable Capture Threshold 567 567
Difficult to Insert 538 538
No Apparent Adverse Event 502 502
Failure to Read Input Signal 431 431
Low Sensing Threshold 417 417
Material Twisted/Bent 380 380
Therapy Delivered to Incorrect Body Area 368 368
Difficult to Remove 322 322
Failure to Advance 314 314
Electrical /Electronic Property Problem 294 294
No Pacing 255 255
Off-Label Use 224 224
Pacing Intermittently 213 213
Activation, Positioning or Separation Problem 203 203
Naturally Worn 192 192
Pocket Stimulation 174 174
Failure to Disconnect 171 171
Failure to Select Signal 140 140
Patient-Device Incompatibility 139 139
Connection Problem 131 131
Stretched 100 100
Sensing Intermittently 100 100
Migration 93 93
Inappropriate/Inadequate Shock/Stimulation 82 82
High Sensing Threshold 82 82
Degraded 72 72
Positioning Failure 72 72
Device Operates Differently Than Expected 65 65
Contamination /Decontamination Problem 59 59
Separation Failure 58 58
Detachment of Device or Device Component 57 57
Electromagnetic Interference 45 45
Accessory Incompatible 43 43
Contamination of Device Ingredient or Reagent 42 42
Device-Device Incompatibility 38 38
Device Contamination with Body Fluid 35 35
Device Contamination with Chemical or Other Material 33 33
Loose or Intermittent Connection 31 31
Human-Device Interface Problem 30 30
Unexpected Therapeutic Results 29 29
Material Split, Cut or Torn 29 29
Material Deformation 29 29
Device Handling Problem 24 24
Improper or Incorrect Procedure or Method 24 24
Deformation Due to Compressive Stress 23 23
Difficult to Advance 22 22
Collapse 21 21
Noise, Audible 20 20
Device Contaminated at the User Facility 17 17
Migration or Expulsion of Device 17 17
Pacing Inadequately 16 16
Incorrect Measurement 15 15
Pacing Asynchronously 15 15
Difficult To Position 14 14
Bent 13 13
Material Separation 13 13
Defective Component 13 13
Fitting Problem 12 12
Malposition of Device 11 11
Device Abrasion From Instrument Or Another Object 11 11
Misassembled 11 11
Product Quality Problem 10 10
Dent in Material 9 9
Incorrect Interpretation of Signal 8 8
Material Too Rigid or Stiff 8 8
Loss of Threshold 7 7
Electronic Property Issue 7 7
Device Damaged by Another Device 7 7
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Misconnection 7 7
Data Problem 7 7
Output Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28237 28237
No Known Impact Or Consequence To Patient 25212 25212
Unspecified Infection 12621 12622
No Consequences Or Impact To Patient 4871 4871
No Code Available 2816 2816
Sepsis 1887 1887
Cardiac Perforation 1467 1467
Death 1263 1263
Dizziness 1202 1202
Discomfort 981 981
Pocket Erosion 922 922
No Information 745 745
Insufficient Information 738 738
Pericardial Effusion 636 636
Bradycardia 613 613
Syncope 593 593
Arrhythmia 584 584
Dyspnea 540 540
Syncope/Fainting 518 518
Chest Pain 484 484
Muscle Stimulation 461 461
Twiddlers Syndrome 448 449
Perforation 429 429
Pain 335 335
Bacterial Infection 333 333
Endocarditis 302 302
Fatigue 285 285
Undesired Nerve Stimulation 240 240
Twiddlers Syndrome 207 207
Erosion 199 199
Fall 195 195
Cardiac Tamponade 182 182
Fever 180 180
Cardiac Arrest 177 177
Hematoma 171 171
Device Overstimulation of Tissue 164 164
Complaint, Ill-Defined 159 159
Wound Dehiscence 144 144
Asystole 138 138
Palpitations 136 136
Low Blood Pressure/ Hypotension 127 127
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 122 122
Pneumothorax 116 116
Tachycardia 91 91
Heart Block 91 91
Atrial Fibrillation 89 89
Swelling 85 85
Purulent Discharge 79 79
Non specific EKG/ECG Changes 76 76
Inflammation 73 73
Swelling/ Edema 72 72
Foreign Body In Patient 69 69
Complete Heart Block 67 67
Hypersensitivity/Allergic reaction 66 66
Pleural Effusion 64 64
Obstruction/Occlusion 61 61
Heart Failure/Congestive Heart Failure 59 59
Staphylococcus Aureus 58 58
Shock from Patient Lead(s) 57 57
Fluid Discharge 56 56
Therapeutic Effects, Unexpected 56 56
Atrial Perforation 55 55
Exit Block 53 53
Weakness 51 51
Occlusion 51 51
Ventricular Fibrillation 50 50
Hemorrhage/Bleeding 49 49
Ventricular Tachycardia 48 48
Presyncope 48 48
Erythema 44 44
Vascular Dissection 40 40
Septic Shock 37 37
Congestive Heart Failure 35 35
Nausea 32 32
High Blood Pressure/ Hypertension 31 31
No Patient Involvement 30 30
Valvular Insufficiency/ Regurgitation 29 29
Thrombosis 29 29
Muscle Weakness 28 28
Heart Failure 28 28
Thrombosis/Thrombus 27 27
Loss of consciousness 25 25
Respiratory Failure 24 24
Failure of Implant 24 24
Cardiopulmonary Arrest 22 22
Abscess 22 22
Hemothorax 20 20
Edema 20 20
Necrosis 20 20
Vomiting 19 19
Cardiomyopathy 19 19
Tricuspid Valve Insufficiency/ Regurgitation 19 19
Unspecified Heart Problem 19 19
Anxiety 18 18
Chest Tightness/Pressure 18 18
Malaise 18 18
Impaired Healing 18 18
Cellulitis 18 18
Perforation of Vessels 18 18
Tricuspid Regurgitation 18 18

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