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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 12

MDR Year MDR Reports MDR Events
2020 546 546
2021 560 560
2022 784 784
2023 948 948
2024 807 807
2025 368 368

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 791 791
Over-Sensing 404 404
Premature Discharge of Battery 357 357
Failure to Interrogate 203 203
Appropriate Term/Code Not Available 203 203
Pacing Problem 196 196
Signal Artifact/Noise 195 195
Failure to Capture 188 188
High Capture Threshold 171 171
High impedance 170 170
Inappropriate/Inadequate Shock/Stimulation 159 159
Under-Sensing 158 158
Impedance Problem 150 150
Pacemaker Found in Back-Up Mode 141 141
Device Dislodged or Dislocated 133 133
Fracture 114 114
No Pacing 106 106
Device Sensing Problem 106 106
Capturing Problem 103 103
Incorrect Measurement 89 89
Failure to Disconnect 79 79
Insufficient Information 79 79
Break 79 79
Loose or Intermittent Connection 69 69
Low impedance 69 69
Data Problem 60 60
Defective Device 58 58
Incorrect, Inadequate or Imprecise Result or Readings 56 56
Battery Problem 49 49
Decreased Sensitivity 47 47
Mechanical Problem 47 47
Electrical /Electronic Property Problem 44 44
Connection Problem 41 41
Difficult to Remove 41 41
Interrogation Problem 35 35
Positioning Problem 27 27
Unstable Capture Threshold 25 25
Misconnection 25 25
Output Problem 23 23
Intermittent Capture 20 20
Electromagnetic Interference 19 19
Inappropriate or Unexpected Reset 18 18
Communication or Transmission Problem 18 18
Material Integrity Problem 16 16
No Apparent Adverse Event 15 15
Use of Device Problem 15 15
Therapeutic or Diagnostic Output Failure 13 13
Wireless Communication Problem 13 13
Display or Visual Feedback Problem 13 13
Contamination of Device Ingredient or Reagent 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2120 2120
Unspecified Infection 513 513
Insufficient Information 251 251
No Known Impact Or Consequence To Patient 199 199
Shock from Patient Lead(s) 145 145
No Consequences Or Impact To Patient 123 123
Arrhythmia 100 100
Syncope/Fainting 87 87
Dizziness 55 55
Heart Failure/Congestive Heart Failure 47 47
Cardiac Arrest 46 46
Discomfort 44 44
Pocket Erosion 43 43
Pericardial Effusion 41 41
Cardiac Tamponade 40 40
Pneumothorax 40 40
Dyspnea 40 40
Cardiac Perforation 39 39
Bacterial Infection 38 38
Bradycardia 38 38
Sepsis 38 38
Endocarditis 34 34
Tachycardia 33 33
Hematoma 32 32
Erosion 31 31
Death 25 25
Tricuspid Valve Insufficiency/ Regurgitation 24 24
Fatigue 23 23
Undesired Nerve Stimulation 22 22
No Code Available 22 22
Pain 22 22
Stroke/CVA 22 22
Chest Pain 22 22
Ventricular Fibrillation 22 22
Asystole 21 21
Electric Shock 21 21
Thrombosis/Thrombus 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Obstruction/Occlusion 18 18
Hemorrhage/Bleeding 17 17
Device Overstimulation of Tissue 17 17
Hemothorax 17 17
Failure of Implant 16 16
Myocardial Infarction 15 15
Perforation 15 15
Swelling/ Edema 14 14
No Information 14 14
Heart Block 12 12
Syncope 12 12
Atrial Fibrillation 11 11

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