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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 0

MDR Year MDR Reports MDR Events
2018 3979 3979
2019 3929 3929
2020 2776 2776
2021 2869 2869
2022 2954 2954

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5156 5156
Device Dislodged or Dislocated 3709 3709
High Capture Threshold 2975 2975
Failure to Capture 2285 2285
High impedance 1228 1228
Capturing Problem 1004 1004
Activation, Positioning or Separation Problem 757 757
Low impedance 445 445
Positioning Problem 440 440
Appropriate Term/Code Not Available 437 437
Impedance Problem 394 394
Break 368 368
Fracture 322 322
Unstable Capture Threshold 226 226
Difficult to Insert 194 194
Intermittent Capture 186 186
Material Integrity Problem 166 166
Difficult to Remove 160 160
Over-Sensing 141 141
Pacing Problem 121 121
Ambient Noise Problem 111 111
Signal Artifact/Noise 97 97
Separation Failure 88 88
Therapy Delivered to Incorrect Body Area 81 81
Insufficient Information 73 73
Failure to Advance 51 51
Device Sensing Problem 48 48
Failure to Sense 47 47
Pocket Stimulation 42 42
Use of Device Problem 36 36
Electrical /Electronic Property Problem 36 36
Under-Sensing 33 33
Device Contamination with Body Fluid 30 30
Mechanical Problem 30 30
Connection Problem 28 28
Improper or Incorrect Procedure or Method 28 28
No Pacing 27 27
Stretched 27 27
Accessory Incompatible 22 22
High Sensing Threshold 20 20
Material Twisted/Bent 19 19
Detachment of Device or Device Component 19 19
Positioning Failure 15 15
Device Handling Problem 14 14
Defective Device 14 14
Device Operates Differently Than Expected 13 13
Material Split, Cut or Torn 12 12
Naturally Worn 11 11
Difficult to Advance 11 11
Loose or Intermittent Connection 11 11
Failure to Disconnect 11 11
Inappropriate/Inadequate Shock/Stimulation 10 10
Material Deformation 9 9
Retraction Problem 9 9
Malposition of Device 8 8
Physical Resistance/Sticking 8 8
Patient-Device Incompatibility 7 7
Pacing Inadequately 6 6
Migration 6 6
Device Contamination with Chemical or Other Material 6 6
Difficult To Position 6 6
Flushing Problem 5 5
No Apparent Adverse Event 5 5
Deformation Due to Compressive Stress 5 5
Low Sensing Threshold 5 5
Detachment Of Device Component 5 5
Material Separation 5 5
Device Damaged by Another Device 5 5
Human-Device Interface Problem 4 4
Migration or Expulsion of Device 4 4
Decreased Sensitivity 4 4
Difficult or Delayed Positioning 4 4
Premature Discharge of Battery 4 4
Difficult to Flush 4 4
Premature Activation 3 3
Microbial Contamination of Device 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Fragmentation 3 3
Bent 3 3
Misconnection 3 3
Device-Device Incompatibility 3 3
Fitting Problem 3 3
Unexpected Therapeutic Results 3 3
Loss of Threshold 2 2
Battery Problem 2 2
Contamination of Device Ingredient or Reagent 2 2
Peeled/Delaminated 2 2
Contamination 2 2
Inadequacy of Device Shape and/or Size 2 2
Product Quality Problem 2 2
Complete Blockage 2 2
Electromagnetic Interference 2 2
Material Too Rigid or Stiff 2 2
Material Protrusion/Extrusion 2 2
Device Markings/Labelling Problem 2 2
Device Displays Incorrect Message 2 2
Misassembled 2 2
Entrapment of Device 2 2
Material Erosion 2 2
Component Missing 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 3908 3908
Unspecified Infection 2942 2942
Undesired Nerve Stimulation 940 940
Muscle Stimulation 787 787
No Consequences Or Impact To Patient 750 750
Device Overstimulation of Tissue 430 430
Death 348 348
Dyspnea 214 214
Pocket Erosion 152 152
Endocarditis 146 146
Sepsis 141 141
Discomfort 140 140
Erosion 140 140
Twiddlers Syndrome 111 111
Pericardial Effusion 96 96
Bacterial Infection 82 82
Hematoma 79 79
Chest Pain 79 79
Fatigue 71 71
Vascular Dissection 70 70
Fever 69 69
Wound Dehiscence 68 68
Dizziness 65 65
Insufficient Information 61 61
Pain 59 59
Erythema 56 56
No Code Available 55 55
Cardiac Arrest 50 50
Pneumothorax 46 46
Cardiac Perforation 46 46
Arrhythmia 45 45
Swelling 45 45
Heart Failure 44 44
Complaint, Ill-Defined 44 44
Cardiac Tamponade 42 42
Swelling/ Edema 41 41
Syncope 38 38
Hiccups 36 36
Twitching 36 36
Syncope/Fainting 35 35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 35 35
Fall 34 34
Heart Failure/Congestive Heart Failure 34 34
Low Blood Pressure/ Hypotension 32 32
Twiddlers Syndrome 30 30
No Information 30 30
Pleural Effusion 29 29
Septic Shock 28 28
Obstruction/Occlusion 26 26
Ventricular Fibrillation 26 26
Purulent Discharge 25 25
Palpitations 24 24
Congestive Heart Failure 22 22
Occlusion 22 22
Perforation 21 21
Tachycardia 21 21
Weakness 20 20
Thrombosis 20 20
Ventricular Tachycardia 20 20
Bradycardia 20 20
Inflammation 19 19
Chills 18 18
Fluid Discharge 18 18
Thrombosis/Thrombus 17 17
Impaired Healing 17 17
Perforation of Vessels 17 17
Muscle Weakness 16 16
Cardiogenic Shock 16 16
Drug Resistant Bacterial Infection 15 15
Exit Block 14 14
Non specific EKG/ECG Changes 13 13
Failure of Implant 12 12
Atrial Fibrillation 12 12
Thrombus 11 11
Sleep Dysfunction 11 11
Hypersensitivity/Allergic reaction 11 11
Nausea 11 11
Pulmonary Edema 10 10
Muscle Spasm(s) 10 10
Discharge 10 10
Cardiopulmonary Arrest 10 10
Pneumonia 10 10
Vomiting 9 9
Stenosis 9 9
High Blood Pressure/ Hypertension 9 9
Shock from Patient Lead(s) 9 9
Heart Block 9 9
Necrosis 8 8
Edema 8 8
Renal Failure 8 8
Therapeutic Effects, Unexpected 8 8
Abscess 8 8
Presyncope 7 7
Asystole 6 6
Hypoxia 6 6
Myocardial Infarction 6 6
Cellulitis 6 6
Malaise 6 6
Cardiomyopathy 6 6

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