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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 left ventricular (lv) pacemaker electrode
Definition Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart.
Product CodeOJX
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
24 21 19 19 9 3

MDR Year MDR Reports MDR Events
2018 3979 3979
2019 3929 3929
2020 2776 2776
2021 2869 2869
2022 2955 2955
2023 478 478

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5307 5307
Device Dislodged or Dislocated 3777 3777
High Capture Threshold 3073 3073
Failure to Capture 2340 2340
High impedance 1269 1269
Capturing Problem 1058 1058
Activation, Positioning or Separation Problem 787 787
Low impedance 464 464
Positioning Problem 454 454
Appropriate Term/Code Not Available 445 445
Impedance Problem 410 410
Break 382 382
Fracture 331 331
Unstable Capture Threshold 237 237
Difficult to Insert 194 194
Intermittent Capture 191 191
Material Integrity Problem 174 174
Difficult to Remove 165 165
Over-Sensing 145 145
Pacing Problem 127 127
Ambient Noise Problem 115 115
Signal Artifact/Noise 99 99
Separation Failure 88 88
Therapy Delivered to Incorrect Body Area 83 83
Insufficient Information 74 74
Failure to Advance 53 53
Device Sensing Problem 50 50
Failure to Sense 48 48
Pocket Stimulation 42 42
Electrical /Electronic Property Problem 38 38
Use of Device Problem 36 36
Under-Sensing 35 35
Device Contamination with Body Fluid 33 33
Mechanical Problem 31 31
Stretched 29 29
Improper or Incorrect Procedure or Method 29 29
Connection Problem 29 29
No Pacing 28 28
Accessory Incompatible 22 22
Material Twisted/Bent 20 20
High Sensing Threshold 20 20
Detachment of Device or Device Component 19 19
Device Handling Problem 18 18
Defective Device 17 17
Positioning Failure 15 15
Material Split, Cut or Torn 13 13
Device Operates Differently Than Expected 13 13
Naturally Worn 11 11
Difficult to Advance 11 11
Failure to Disconnect 11 11
Loose or Intermittent Connection 11 11
Inappropriate/Inadequate Shock/Stimulation 10 10
Retraction Problem 9 9
Material Deformation 9 9
Physical Resistance/Sticking 8 8
Malposition of Device 8 8
Patient-Device Incompatibility 7 7
Migration 6 6
No Apparent Adverse Event 6 6
Device Contamination with Chemical or Other Material 6 6
Difficult To Position 6 6
Pacing Inadequately 6 6
Migration or Expulsion of Device 5 5
Material Separation 5 5
Flushing Problem 5 5
Detachment Of Device Component 5 5
Device Damaged by Another Device 5 5
Low Sensing Threshold 5 5
Deformation Due to Compressive Stress 5 5
Decreased Sensitivity 4 4
Human-Device Interface Problem 4 4
Difficult or Delayed Positioning 4 4
Premature Discharge of Battery 4 4
Difficult to Flush 4 4
Premature Activation 4 4
Unexpected Therapeutic Results 3 3
Misconnection 3 3
Material Fragmentation 3 3
Bent 3 3
Device-Device Incompatibility 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Fitting Problem 3 3
Microbial Contamination of Device 3 3
Component Missing 2 2
Battery Problem 2 2
Device Markings/Labelling Problem 2 2
Contamination of Device Ingredient or Reagent 2 2
Device Displays Incorrect Message 2 2
Material Protrusion/Extrusion 2 2
Output Problem 2 2
Packaging Problem 2 2
Noise, Audible 2 2
Complete Blockage 2 2
Crack 2 2
Degraded 2 2
Contamination 2 2
Electromagnetic Interference 2 2
Entrapment of Device 2 2
Material Erosion 2 2
Peeled/Delaminated 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5403 5403
No Clinical Signs, Symptoms or Conditions 4199 4199
Unspecified Infection 3031 3031
Undesired Nerve Stimulation 958 958
Muscle Stimulation 787 787
No Consequences Or Impact To Patient 750 750
Device Overstimulation of Tissue 453 453
Death 348 348
Dyspnea 218 218
Pocket Erosion 157 157
Endocarditis 149 149
Sepsis 148 148
Discomfort 146 146
Erosion 143 143
Twiddlers Syndrome 111 111
Pericardial Effusion 100 100
Bacterial Infection 92 92
Chest Pain 85 85
Hematoma 79 79
Fatigue 72 72
Insufficient Information 71 71
Vascular Dissection 71 71
Fever 70 70
Dizziness 70 70
Wound Dehiscence 69 69
Pain 61 61
Erythema 57 57
No Code Available 55 55
Cardiac Arrest 50 50
Arrhythmia 47 47
Cardiac Perforation 47 47
Pneumothorax 46 46
Swelling 45 45
Complaint, Ill-Defined 44 44
Heart Failure 44 44
Cardiac Tamponade 42 42
Swelling/ Edema 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 39 39
Syncope/Fainting 38 38
Syncope 38 38
Hiccups 36 36
Twitching 36 36
Fall 35 35
Low Blood Pressure/ Hypotension 34 34
Heart Failure/Congestive Heart Failure 34 34
Twiddlers Syndrome 33 33
No Information 30 30
Septic Shock 30 30
Pleural Effusion 30 30
Ventricular Fibrillation 27 27
Obstruction/Occlusion 27 27
Purulent Discharge 25 25
Palpitations 24 24
Tachycardia 23 23
Perforation 22 22
Occlusion 22 22
Congestive Heart Failure 22 22
Bradycardia 20 20
Inflammation 20 20
Ventricular Tachycardia 20 20
Thrombosis 20 20
Weakness 20 20
Fluid Discharge 20 20
Thrombosis/Thrombus 20 20
Chills 18 18
Impaired Healing 18 18
Muscle Weakness 18 18
Perforation of Vessels 17 17
Drug Resistant Bacterial Infection 17 17
Cardiogenic Shock 16 16
Atrial Fibrillation 14 14
Exit Block 14 14
Non specific EKG/ECG Changes 13 13
Failure of Implant 12 12
Sleep Dysfunction 12 12
Hypersensitivity/Allergic reaction 11 11
Thrombus 11 11
Nausea 11 11
Pneumonia 11 11
Necrosis 10 10
Muscle Spasm(s) 10 10
Pulmonary Edema 10 10
Discharge 10 10
Cardiopulmonary Arrest 10 10
Shock from Patient Lead(s) 10 10
Heart Block 9 9
High Blood Pressure/ Hypertension 9 9
Stenosis 9 9
Vomiting 9 9
Renal Failure 8 8
Therapeutic Effects, Unexpected 8 8
Edema 8 8
Abscess 8 8
Presyncope 8 8
Asystole 8 8
Cellulitis 7 7
Hypoxia 7 7
Cardiomyopathy 6 6
Staphylococcus Aureus 6 6
Myocardial Infarction 6 6

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