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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 2

MDR Year MDR Reports MDR Events
2020 546 546
2021 560 560
2022 784 784
2023 948 948
2024 811 811
2025 78 78

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 729 729
Over-Sensing 368 368
Premature Discharge of Battery 338 338
Failure to Interrogate 194 194
Failure to Capture 179 179
Signal Artifact/Noise 179 179
Pacing Problem 178 178
Appropriate Term/Code Not Available 173 173
High Capture Threshold 154 154
High impedance 152 152
Under-Sensing 150 150
Impedance Problem 142 142
Pacemaker Found in Back-Up Mode 141 141
Inappropriate/Inadequate Shock/Stimulation 133 133
Device Dislodged or Dislocated 124 124
Fracture 100 100
No Pacing 99 99
Device Sensing Problem 97 97
Capturing Problem 93 93
Incorrect Measurement 87 87
Insufficient Information 73 73
Failure to Disconnect 72 72
Break 70 70
Low impedance 64 64
Loose or Intermittent Connection 64 64
Data Problem 58 58
Defective Device 53 53
Incorrect, Inadequate or Imprecise Result or Readings 51 51
Decreased Sensitivity 46 46
Battery Problem 45 45
Mechanical Problem 45 45
Electrical /Electronic Property Problem 43 43
Connection Problem 40 40
Difficult to Remove 38 38
Interrogation Problem 31 31
Positioning Problem 26 26
Misconnection 25 25
Unstable Capture Threshold 25 25
Output Problem 22 22
Intermittent Capture 20 20
Electromagnetic Interference 17 17
Inappropriate or Unexpected Reset 17 17
Communication or Transmission Problem 17 17
Material Integrity Problem 16 16
Use of Device Problem 15 15
No Apparent Adverse Event 14 14
Therapeutic or Diagnostic Output Failure 13 13
Display or Visual Feedback Problem 13 13
Wireless Communication Problem 12 12
Pacing Asynchronously 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1958 1958
Unspecified Infection 469 469
Insufficient Information 237 237
No Known Impact Or Consequence To Patient 199 199
No Consequences Or Impact To Patient 123 123
Shock from Patient Lead(s) 118 118
Arrhythmia 94 94
Syncope/Fainting 84 84
Dizziness 52 52
Cardiac Arrest 41 41
Discomfort 40 40
Pocket Erosion 40 40
Cardiac Tamponade 39 39
Dyspnea 38 38
Pneumothorax 37 37
Pericardial Effusion 37 37
Bradycardia 36 36
Heart Failure/Congestive Heart Failure 36 36
Sepsis 35 35
Cardiac Perforation 34 34
Bacterial Infection 32 32
Endocarditis 31 31
Tachycardia 29 29
Erosion 28 28
Hematoma 26 26
Death 25 25
Fatigue 23 23
No Code Available 22 22
Ventricular Fibrillation 21 21
Asystole 21 21
Pain 21 21
Tricuspid Valve Insufficiency/ Regurgitation 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Chest Pain 20 20
Electric Shock 20 20
Undesired Nerve Stimulation 19 19
Stroke/CVA 19 19
Hemothorax 17 17
Device Overstimulation of Tissue 17 17
Hemorrhage/Bleeding 17 17
Thrombosis/Thrombus 16 16
Obstruction/Occlusion 16 16
Failure of Implant 15 15
No Information 14 14
Perforation 14 14
Myocardial Infarction 14 14
Swelling/ Edema 13 13
Syncope 12 12
Heart Block 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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