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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
Product CodeDXY
Regulation Number 870.3610
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
19 23 20 14 19 9

MDR Year MDR Reports MDR Events
2019 1799 1799
2020 546 546
2021 560 560
2022 784 784
2023 948 948
2024 549 549

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1191 1191
Over-Sensing 525 525
Signal Artifact/Noise 422 422
Premature Discharge of Battery 350 350
Device Dislodged or Dislocated 321 321
Failure to Capture 299 299
High Capture Threshold 251 251
Failure to Interrogate 224 224
High impedance 214 214
Pacemaker Found in Back-Up Mode 210 210
Pacing Problem 210 210
Appropriate Term/Code Not Available 189 189
Under-Sensing 185 185
Impedance Problem 152 152
Inappropriate/Inadequate Shock/Stimulation 145 145
Device Sensing Problem 134 134
Fracture 126 126
No Pacing 117 117
Break 114 114
Capturing Problem 108 108
Low impedance 96 96
Incorrect Measurement 90 90
Data Problem 88 88
Insufficient Information 74 74
Failure to Disconnect 67 67
Decreased Sensitivity 62 62
Loose or Intermittent Connection 60 60
Defective Device 56 56
Mechanical Problem 53 53
Battery Problem 52 52
Incorrect, Inadequate or Imprecise Result or Readings 52 52
Connection Problem 51 51
Misconnection 50 50
Electrical /Electronic Property Problem 44 44
Difficult to Remove 42 42
Positioning Problem 39 39
Unstable Capture Threshold 36 36
Intermittent Capture 34 34
Communication or Transmission Problem 31 31
Wireless Communication Problem 29 29
Failure to Sense 28 28
Output Problem 26 26
Interrogation Problem 26 26
Inappropriate or Unexpected Reset 23 23
Electromagnetic Interference 20 20
Low Sensing Threshold 19 19
Material Integrity Problem 18 18
Use of Device Problem 18 18
No Apparent Adverse Event 15 15
Therapeutic or Diagnostic Output Failure 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1743 1743
No Known Impact Or Consequence To Patient 1276 1276
Unspecified Infection 761 761
Insufficient Information 224 224
No Consequences Or Impact To Patient 129 129
Shock from Patient Lead(s) 129 129
Death 123 123
Arrhythmia 94 94
Dizziness 85 85
Syncope/Fainting 81 81
Pocket Erosion 75 75
Discomfort 53 53
Dyspnea 51 51
Syncope 51 51
Bradycardia 46 46
Cardiac Arrest 43 43
Sepsis 38 38
Cardiac Perforation 37 37
Cardiac Tamponade 37 37
Pericardial Effusion 37 37
Hematoma 37 37
Pneumothorax 36 36
Tachycardia 35 35
Erosion 34 34
No Information 34 34
Endocarditis 32 32
Undesired Nerve Stimulation 31 31
Heart Failure/Congestive Heart Failure 30 30
Pain 30 30
Fatigue 29 29
No Code Available 29 29
Chest Pain 28 28
Bacterial Infection 26 26
Twiddlers Syndrome 23 23
Ventricular Fibrillation 23 23
Muscle Stimulation 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Electric Shock 20 20
Asystole 18 18
Wound Dehiscence 16 16
Swelling 16 16
Tricuspid Valve Insufficiency/ Regurgitation 16 16
Device Overstimulation of Tissue 16 16
Stroke/CVA 16 16
Atrial Fibrillation 16 16
Fall 15 15
Hemothorax 15 15
Myocardial Infarction 14 14
Thrombosis/Thrombus 14 14
Hemorrhage/Bleeding 13 13

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