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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 12

MDR Year MDR Reports MDR Events
2021 561 563
2022 784 791
2023 922 931
2024 773 775
2025 817 817
2026 593 593

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 927 927
Over-Sensing 475 476
Premature Discharge of Battery 366 367
Appropriate Device Problem Term/Code Not Available 265 266
Signal Artifact/Noise 225 226
Pacing Problem 222 224
Failure to Capture 202 202
Failure to Interrogate 195 195
Inappropriate/Inadequate Shock/Stimulation 191 191
High Capture Threshold 183 185
High impedance 180 181
Under-Sensing 169 170
Device Dislodged or Dislocated 153 153
Impedance Problem 151 152
Device Sensing Problem 128 128
Fracture 118 118
Capturing Problem 106 106
Pacemaker Found in Back-Up Mode 105 106
Insufficient Device Problem Information 102 102
No Pacing 93 93
Low impedance 86 86
Incorrect Measurement 86 86
Failure to Disconnect 79 80
Break 74 74
Loose or Intermittent Connection 68 69
Incorrect, Inadequate or Imprecise Result or Readings 68 68
Unexpected Mode Switch 63 63
Defective Device 59 60
Interrogation Problem 55 55
Data Problem 52 53
Battery Problem 52 52
Connection Problem 51 52
Decreased Sensitivity 50 50
Electrical /Electronic Property Problem 43 44
Difficult to Remove 39 42
Mechanical Problem 36 36
Positioning Problem 29 29
Unstable Capture Threshold 22 22
Inappropriate or Unexpected Reset 20 20
Output Problem 20 20
Material Integrity Problem 19 20
Use of Device Problem 18 18
Communication or Transmission Problem 17 17
Electromagnetic Interference 17 17
Wireless Communication Problem 16 16
No Apparent Adverse Event 16 16
Intermittent Capture 16 16
Display or Visual Feedback Problem 14 14
Pacing Asynchronously 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 2620 2638
Unspecified Infection 608 608
Insufficient Information 335 335
Shock from Patient Lead(s) 189 189
Syncope/Fainting 105 105
Arrhythmia 100 101
Heart Failure/Congestive Heart Failure 84 84
Cardiac Arrest 71 71
Sepsis 64 64
Pneumothorax 64 64
Pericardial Effusion 63 63
Bacterial Infection 57 57
Dizziness 56 56
Cardiac Perforation 53 53
Endocarditis 50 50
Discomfort 44 44
Cardiac Tamponade 44 44
Dyspnea 41 42
Bradycardia 40 40
Pocket Erosion 39 39
Tachycardia 39 39
Erosion 38 38
Hematoma 36 36
Tricuspid Valve Insufficiency/ Regurgitation 34 34
Thrombosis/Thrombus 34 34
Asystole 32 32
Hemorrhage/Blood Loss/Bleeding 30 30
Stroke/CVA 27 27
Chest Pain 26 26
Device Overstimulation of Tissue 25 25
Medical device site infection 25 25
Undesired Nerve Stimulation 24 24
Obstruction/Occlusion 24 24
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 23 23
Fatigue 22 22
Myocardial Infarction 22 22
Swelling/ Edema 21 21
Pain 21 21
Ventricular Fibrillation 20 20
Hemothorax 20 20
Heart Block 19 19
Failure of Implant 18 18
Electric Shock 17 17
Fever 16 16
Cardiogenic Shock 16 16
Pulmonary Embolism 16 16
Atrial Fibrillation 16 16
Wound Dehiscence 15 15
Low Blood Pressure/ Hypotension 15 15
Presyncope 15 15

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