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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)
2020 2021 2022 2023 2024 2025
23 20 14 19 20 17

MDR Year MDR Reports MDR Events
2020 546 546
2021 560 562
2022 784 791
2023 922 931
2024 773 775
2025 745 745

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 849 849
Over-Sensing 452 453
Premature Discharge of Battery 379 380
Appropriate Term/Code Not Available 239 240
Signal Artifact/Noise 216 217
Failure to Interrogate 212 212
Pacing Problem 208 210
Failure to Capture 195 195
High Capture Threshold 185 187
High impedance 184 185
Inappropriate/Inadequate Shock/Stimulation 171 171
Under-Sensing 167 168
Impedance Problem 159 160
Device Dislodged or Dislocated 148 148
Pacemaker Found in Back-Up Mode 140 141
Fracture 127 127
Device Sensing Problem 118 118
No Pacing 112 112
Capturing Problem 108 108
Incorrect Measurement 92 92
Break 88 88
Failure to Disconnect 84 85
Insufficient Information 82 82
Low impedance 73 73
Loose or Intermittent Connection 70 71
Defective Device 65 66
Data Problem 59 60
Incorrect, Inadequate or Imprecise Result or Readings 57 57
Battery Problem 56 56
Mechanical Problem 52 52
Decreased Sensitivity 51 51
Connection Problem 48 49
Electrical /Electronic Property Problem 45 46
Difficult to Remove 42 45
Interrogation Problem 39 39
Positioning Problem 29 29
Unstable Capture Threshold 26 26
Output Problem 25 25
Misconnection 25 25
Electromagnetic Interference 20 20
Communication or Transmission Problem 19 19
Inappropriate or Unexpected Reset 18 18
Use of Device Problem 18 18
Intermittent Capture 18 18
Material Integrity Problem 17 18
No Apparent Adverse Event 15 15
Therapeutic or Diagnostic Output Failure 15 15
Display or Visual Feedback Problem 14 14
Contamination of Device Ingredient or Reagent 14 14
Wireless Communication Problem 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2313 2331
Unspecified Infection 557 557
Insufficient Information 271 271
No Known Impact Or Consequence To Patient 199 199
Shock from Patient Lead(s) 162 162
No Consequences Or Impact To Patient 123 123
Arrhythmia 104 105
Syncope/Fainting 95 95
Heart Failure/Congestive Heart Failure 66 66
Dizziness 60 60
Cardiac Arrest 54 54
Pericardial Effusion 53 53
Pneumothorax 50 50
Discomfort 46 46
Cardiac Perforation 46 46
Cardiac Tamponade 45 45
Sepsis 44 44
Bacterial Infection 44 44
Pocket Erosion 43 43
Endocarditis 43 43
Bradycardia 39 39
Dyspnea 39 40
Tachycardia 37 37
Erosion 36 36
Hematoma 33 33
Tricuspid Valve Insufficiency/ Regurgitation 27 27
Stroke/CVA 25 25
Death 25 25
Fatigue 25 25
Undesired Nerve Stimulation 25 25
Asystole 25 25
Hemorrhage/Bleeding 25 25
Thrombosis/Thrombus 24 24
Pain 23 23
Chest Pain 22 22
No Code Available 22 22
Ventricular Fibrillation 22 22
Obstruction/Occlusion 21 21
Device Overstimulation of Tissue 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Electric Shock 19 19
Failure of Implant 19 19
Hemothorax 19 19
Atrial Fibrillation 16 16
Swelling/ Edema 16 16
Perforation 16 16
Myocardial Infarction 15 15
Heart Block 15 15
Fever 15 15
No Information 14 14

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