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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implantable pacemaker pulse-generator
Regulation Description Implantable pacemaker pulse generator.
Product CodeDXY
Regulation Number 870.3610
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
20 14 19 20 19 11

MDR Year MDR Reports MDR Events
2021 561 563
2022 784 791
2023 922 931
2024 773 775
2025 818 818
2026 519 519

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 914 914
Over-Sensing 470 471
Premature Discharge of Battery 355 356
Appropriate Device Problem Term/Code Not Available 265 266
Signal Artifact/Noise 222 223
Pacing Problem 217 219
Failure to Capture 200 200
Failure to Interrogate 195 195
Inappropriate/Inadequate Shock/Stimulation 186 186
High Capture Threshold 177 179
High impedance 176 177
Under-Sensing 167 168
Impedance Problem 149 150
Device Dislodged or Dislocated 143 143
Device Sensing Problem 128 128
Fracture 116 116
Pacemaker Found in Back-Up Mode 105 106
Capturing Problem 104 104
Insufficient Device Problem Information 98 98
No Pacing 93 93
Incorrect Measurement 86 86
Low impedance 84 84
Failure to Disconnect 77 78
Break 72 72
Loose or Intermittent Connection 67 68
Incorrect, Inadequate or Imprecise Result or Readings 65 65
Unexpected Mode Switch 60 60
Defective Device 59 60
Battery Problem 51 51
Data Problem 51 52
Connection Problem 50 51
Interrogation Problem 50 50
Decreased Sensitivity 48 48
Electrical /Electronic Property Problem 41 42
Difficult to Remove 39 42
Mechanical Problem 36 36
Positioning Problem 29 29
Unstable Capture Threshold 22 22
Output Problem 20 20
Inappropriate or Unexpected Reset 20 20
Material Integrity Problem 19 20
Use of Device Problem 18 18
Communication or Transmission Problem 17 17
Electromagnetic Interference 17 17
Intermittent Capture 16 16
Wireless Communication Problem 15 15
No Apparent Adverse Event 15 15
Pacing Asynchronously 14 14
Display or Visual Feedback Problem 14 14
Contamination of Device Ingredient or Reagent 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2575 2593
Unspecified Infection 602 602
Insufficient Information 331 331
Shock from Patient Lead(s) 185 185
Syncope/Fainting 103 103
Arrhythmia 99 100
Heart Failure/Congestive Heart Failure 78 78
Cardiac Arrest 71 71
Sepsis 64 64
Pericardial Effusion 62 62
Pneumothorax 60 60
Bacterial Infection 57 57
Dizziness 56 56
Cardiac Perforation 52 52
Endocarditis 50 50
Discomfort 44 44
Cardiac Tamponade 42 42
Dyspnea 41 42
Bradycardia 40 40
Erosion 38 38
Pocket Erosion 38 38
Tachycardia 37 37
Hematoma 35 35
Thrombosis/Thrombus 34 34
Tricuspid Valve Insufficiency/ Regurgitation 33 33
Asystole 32 32
Hemorrhage/Blood Loss/Bleeding 29 29
Stroke/CVA 27 27
Chest Pain 26 26
Obstruction/Occlusion 24 24
Undesired Nerve Stimulation 24 24
Device Overstimulation of Tissue 23 23
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 23 23
Fatigue 22 22
Pain 21 21
Myocardial Infarction 21 21
Medical device site infection 21 21
Hemothorax 20 20
Swelling/ Edema 20 20
Heart Block 19 19
Ventricular Fibrillation 19 19
Failure of Implant 18 18
Electric Shock 17 17
Pulmonary Embolism 16 16
Fever 16 16
Cardiogenic Shock 16 16
Low Blood Pressure/ Hypotension 15 15
Wound Dehiscence 15 15
Atrial Fibrillation 15 15
Purulent Discharge 15 15

Recalls
Manufacturer Recall Class Date Posted
1 St. Jude Medical, Cardiac Rhythm Management Division II Aug-02-2022
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