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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)
2018 2019 2020 2021 2022 2023 2024 2025 2026
45 19 23 20 14 19 20 19 13

MDR Year MDR Reports MDR Events
2018 2070 2073
2019 1799 1800
2020 546 546
2021 561 563
2022 784 791
2023 922 931
2024 773 775
2025 817 817
2026 656 656

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2194 2194
Over-Sensing 929 930
Device Dislodged or Dislocated 727 727
Signal Artifact/Noise 692 693
Failure to Capture 541 541
Premature Discharge of Battery 509 510
High Capture Threshold 438 440
Appropriate Device Problem Term/Code Not Available 385 386
High impedance 373 374
Pacing Problem 324 326
Failure to Interrogate 301 301
Under-Sensing 281 282
Inappropriate/Inadequate Shock/Stimulation 263 263
Pacemaker Found in Back-Up Mode 255 257
Device Sensing Problem 248 248
Impedance Problem 239 240
Fracture 227 227
Break 207 207
Low impedance 189 189
Capturing Problem 184 184
No Pacing 155 155
Insufficient Device Problem Information 127 127
Data Problem 120 121
Incorrect Measurement 117 117
Decreased Sensitivity 100 100
Failure to Sense 98 98
Connection Problem 94 95
Failure to Disconnect 92 93
Mechanical Problem 87 87
Battery Problem 85 85
Loose or Intermittent Connection 79 80
Incorrect, Inadequate or Imprecise Result or Readings 78 78
Defective Device 73 74
Interrogation Problem 67 67
Unexpected Mode Switch 66 66
Misconnection 63 63
Difficult to Remove 56 59
Electrical /Electronic Property Problem 55 56
Intermittent Capture 55 55
Unstable Capture Threshold 51 51
Positioning Problem 51 51
Communication or Transmission Problem 46 46
Inappropriate or Unexpected Reset 43 43
Output Problem 41 41
Wireless Communication Problem 38 38
Difficult to Insert 36 36
Material Integrity Problem 36 37
Low Sensing Threshold 34 34
Electromagnetic Interference 27 27
Retraction Problem 25 25

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2719 2738
No Known Impact Or Consequence To Patient 2343 2344
Unspecified Infection 1426 1426
Insufficient Information 343 343
Shock from Patient Lead(s) 252 252
Death 251 251
No Consequences Or Impact To Patient 162 162
Arrhythmia 139 140
Dizziness 133 135
Pericardial Effusion 127 127
Pocket Erosion 114 114
Syncope/Fainting 108 108
Cardiac Arrest 103 103
Pneumothorax 100 100
Dyspnea 97 98
Cardiac Perforation 92 92
Heart Failure/Congestive Heart Failure 88 88
Bradycardia 86 86
Sepsis 85 85
Chest Pain 84 84
Syncope 84 86
Endocarditis 80 80
Discomfort 79 80
Hematoma 77 77
No Information 75 75
Cardiac Tamponade 72 72
Bacterial Infection 66 66
Erosion 63 63
Pain 50 50
Twiddlers Syndrome 50 50
Tachycardia 49 49
Muscle Stimulation 46 46
Fatigue 45 45
Undesired Nerve Stimulation 45 45
No Code Available 44 44
Fever 42 42
Complaint, Ill-Defined 40 40
Atrial Fibrillation 39 39
Wound Dehiscence 38 38
Ventricular Fibrillation 38 38
Thrombosis/Thrombus 36 36
Tricuspid Valve Insufficiency/ Regurgitation 35 35
Hemorrhage/Blood Loss/Bleeding 35 35
Palpitations 34 34
Asystole 32 32
Stroke/CVA 32 32
Hemothorax 32 32
Swelling 31 31
Low Blood Pressure/ Hypotension 30 30
Medical device site infection 27 27

Recalls
Manufacturer Recall Class Date Posted
1 St Jude Medical Inc. II Jun-12-2018
2 St. Jude Medical, Cardiac Rhythm Management Division II Aug-02-2022
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