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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device leadless pacemaker
Definition To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.
Product CodePNJ
Regulation Number 870.3610
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
15 27 37 36 22 9

MDR Year MDR Reports MDR Events
2019 837 837
2020 1147 1147
2021 1479 1479
2022 1712 1712
2023 2627 2627
2024 1007 1007

Device Problems MDRs with this Device Problem Events in those MDRs
High Capture Threshold 1876 1876
Adverse Event Without Identified Device or Use Problem 1498 1498
Failure to Capture 1036 1036
Pacing Problem 1009 1009
Capturing Problem 1005 1005
Positioning Problem 963 963
Use of Device Problem 907 907
Device Dislodged or Dislocated 838 838
Appropriate Term/Code Not Available 595 595
Under-Sensing 562 562
Material Integrity Problem 413 413
Premature Discharge of Battery 408 408
Device Sensing Problem 295 295
Mechanical Problem 289 289
Decreased Sensitivity 267 267
Unstable Capture Threshold 221 221
High impedance 220 220
Leak/Splash 209 209
Failure to Interrogate 195 195
Intermittent Capture 189 189
Stretched 184 184
Impedance Problem 182 182
Activation, Positioning or Separation Problem 159 159
Over-Sensing 135 135
Premature Separation 121 121
Electrical /Electronic Property Problem 114 114
Low impedance 99 99
Deformation Due to Compressive Stress 83 83
Inappropriate or Unexpected Reset 83 83
Communication or Transmission Problem 70 70
Reset Problem 63 63
Coagulation in Device or Device Ingredient 57 57
Incorrect Measurement 56 56
Connection Problem 55 55
Failure to Advance 52 52
Separation Failure 51 51
Insufficient Information 48 48
Output Problem 42 42
Positioning Failure 42 42
Migration or Expulsion of Device 41 41
Incorrect, Inadequate or Imprecise Result or Readings 41 41
Difficult to Flush 39 39
Battery Problem 38 38
Intermittent Communication Failure 37 37
Difficult or Delayed Positioning 36 36
Signal Artifact/Noise 34 34
Break 31 31
Difficult or Delayed Separation 31 31
Material Twisted/Bent 30 30
Interrogation Problem 20 20
Unable to Obtain Readings 19 19
Difficult to Remove 15 15
Failure to Sense 14 14
Fracture 14 14
Material Fragmentation 13 13
Electromagnetic Interference 13 13
Device-Device Incompatibility 13 13
No Apparent Adverse Event 13 13
Data Problem 12 12
Pacing Asynchronously 11 11
Failure to Align 8 8
Defective Device 7 7
Material Deformation 7 7
No Pacing 7 7
Activation Failure 7 7
Device Contamination with Chemical or Other Material 6 6
Loss of Data 4 4
Device Handling Problem 4 4
Device Contaminated During Manufacture or Shipping 3 3
Packaging Problem 3 3
Patient Device Interaction Problem 3 3
Detachment of Device or Device Component 3 3
Device Markings/Labelling Problem 3 3
Therapy Delivered to Incorrect Body Area 3 3
Labelling, Instructions for Use or Training Problem 3 3
Difficult to Insert 2 2
Loose or Intermittent Connection 2 2
Contamination 2 2
Use of Incorrect Control/Treatment Settings 2 2
Human-Device Interface Problem 2 2
Difficult or Delayed Activation 2 2
Computer Operating System Problem 2 2
Sensing Intermittently 2 2
Missing Test Results 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 1 1
Protective Measures Problem 1 1
Operating System Version or Upgrade Problem 1 1
Mechanics Altered 1 1
Migration 1 1
Physical Resistance/Sticking 1 1
Activation Problem 1 1
Unexpected Therapeutic Results 1 1
Failure to Analyze Signal 1 1
High Sensing Threshold 1 1
Obstruction of Flow 1 1
Improper or Incorrect Procedure or Method 1 1
Malposition of Device 1 1
Difficult to Advance 1 1
Collapse 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4451 4451
Pericardial Effusion 896 896
No Known Impact Or Consequence To Patient 778 778
Cardiac Perforation 775 775
Cardiac Tamponade 630 630
Bradycardia 430 430
Low Blood Pressure/ Hypotension 343 343
No Consequences Or Impact To Patient 341 341
Arrhythmia 270 270
Cardiac Arrest 251 251
Dyspnea 201 201
Insufficient Information 158 158
Dizziness 150 150
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 148 148
Syncope/Fainting 137 137
Chest Pain 134 134
Unspecified Infection 134 134
Death 125 125
Tachycardia 114 114
Perforation 106 106
Heart Block 104 104
Discomfort 81 81
Embolism/Embolus 80 80
Thrombosis/Thrombus 77 77
Heart Failure/Congestive Heart Failure 68 68
Hemorrhage/Bleeding 67 67
Fatigue 64 64
Asystole 63 63
Ventricular Fibrillation 59 59
Non specific EKG/ECG Changes 54 54
Hematoma 48 48
Pain 47 47
Sepsis 45 45
Pleural Effusion 37 37
Loss of consciousness 34 34
Fall 34 34
Tricuspid Valve Insufficiency/ Regurgitation 34 34
No Code Available 33 33
Endocarditis 31 31
Cardiomyopathy 31 31
Syncope 30 30
Fever 30 30
Atrial Fibrillation 28 28
Stroke/CVA 26 26
Swelling/ Edema 24 24
Muscle Weakness 23 23
Pulmonary Embolism 22 22
Pseudoaneurysm 22 22
Ventricular Tachycardia 21 21
Thrombus 20 20
Respiratory Failure 19 19
Presyncope 18 18
Heart Failure 18 18
Bacterial Infection 18 18
High Blood Pressure/ Hypertension 18 18
Complete Heart Block 17 17
Myocardial Infarction 16 16
Palpitations 16 16
Hypoxia 15 15
Fistula 15 15
Nausea 13 13
Pericarditis 13 13
Inflammation 12 12
Thrombosis 11 11
Pneumonia 11 11
Low Oxygen Saturation 10 10
Obstruction/Occlusion 10 10
Convulsion/Seizure 10 10
Vascular Dissection 9 9
No Patient Involvement 9 9
Renal Failure 9 9
Device Overstimulation of Tissue 9 9
Headache 9 9
Hemothorax 8 8
Laceration(s) 8 8
Pneumothorax 8 8
Pulmonary Edema 8 8
Perforation of Vessels 8 8
Cardiogenic Shock 8 8
Unspecified Tissue Injury 8 8
Respiratory Arrest 7 7
Exit Block 7 7
Diminished Pulse Pressure 7 7
Malaise 7 7
Septic Shock 7 7
Hypersensitivity/Allergic reaction 7 7
Abdominal Pain 7 7
Atrial Flutter 6 6
Erosion 6 6
Ischemia 6 6
Weight Changes 6 6
Cardiovascular Insufficiency 6 6
Ectopic Heartbeat 5 5
Respiratory Insufficiency 5 5
Sleep Dysfunction 5 5
Anemia 5 5
Shock 5 5
Vomiting 5 5
Tricuspid Regurgitation 5 5
Complaint, Ill-Defined 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical II Apr-29-2024
2 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Sep-09-2019
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