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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)
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 15 52 45 19 23 20 14 19 2

MDR Year MDR Reports MDR Events
2014 5603 5603
2015 1021 1021
2016 540 540
2017 1047 1047
2018 2071 2071
2019 1799 1799
2020 546 546
2021 560 560
2022 784 784
2023 947 947
2024 195 195

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2482 2482
Pacemaker Found in Back-Up Mode 2161 2161
Over-Sensing 1439 1439
Device Dislodged or Dislocated 933 933
Device Operates Differently Than Expected 892 892
Premature Discharge of Battery 793 793
Failure to Capture 762 762
Signal Artifact/Noise 643 643
High Capture Threshold 561 561
Failure to Interrogate 550 550
High impedance 514 514
Pacing Problem 428 428
Under-Sensing 360 360
Connection Problem 348 348
Appropriate Term/Code Not Available 329 329
Device Sensing Problem 297 297
Low impedance 280 280
Device Displays Incorrect Message 278 278
Impedance Problem 277 277
Capturing Problem 276 276
Fracture 272 272
Difficult to Insert 269 269
Inappropriate/Inadequate Shock/Stimulation 255 255
Mechanical Problem 237 237
Break 237 237
Premature Elective Replacement Indicator 227 227
Failure to Sense 195 195
Telemetry Discrepancy 159 159
Incorrect Measurement 151 151
Battery Problem 140 140
No Pacing 138 138
Output Problem 134 134
No Device Output 126 126
Intermittent Capture 114 114
Data Problem 112 112
Insufficient Information 111 111
Decreased Sensitivity 105 105
Inappropriate or Unexpected Reset 85 85
Positioning Problem 80 80
Reset Problem 78 78
Difficult to Remove 74 74
Misconnection 74 74
Loose or Intermittent Connection 74 74
Unstable Capture Threshold 71 71
Failure to Disconnect 66 66
Communication or Transmission Problem 65 65
Nonstandard Device 63 63
Electrical /Electronic Property Problem 49 49
Defective Device 47 47
Sensing Intermittently 46 46
Incorrect, Inadequate or Imprecise Result or Readings 43 43
Invalid Sensing 42 42
Unable to Obtain Readings 40 40
Loss of Data 40 40
Material Integrity Problem 39 39
Premature End-of-Life Indicator 37 37
Low Sensing Threshold 37 37
Retraction Problem 36 36
Electromagnetic Interference 36 36
Difficult to Interrogate 35 35
Wireless Communication Problem 32 32
Out-Of-Box Failure 30 30
Pacing Inadequately 29 29
Activation, Positioning or Separation Problem 28 28
Ambient Noise Problem 28 28
Interrogation Problem 26 26
Programming Issue 25 25
Migration or Expulsion of Device 25 25
Positioning Failure 24 24
Use of Device Problem 24 24
Protective Measures Problem 20 20
Defibrillation/Stimulation Problem 18 18
Fitting Problem 17 17
Battery Problem: High Impedance 17 17
Battery Impedance Issue 15 15
No Apparent Adverse Event 15 15
Pacing Asynchronously 15 15
Degraded 14 14
Therapeutic or Diagnostic Output Failure 14 14
Device-Device Incompatibility 14 14
Electronic Property Issue 14 14
Migration 13 13
Display or Visual Feedback Problem 13 13
Pacing Intermittently 13 13
Separation Failure 12 12
Pocket Stimulation 12 12
Noise, Audible 12 12
Missing Test Results 12 12
Material Deformation 11 11
Contamination of Device Ingredient or Reagent 11 11
Detachment of Device or Device Component 10 10
High Sensing Threshold 10 10
Device Alarm System 10 10
Low Battery 9 9
Failure to Transmit Record 9 9
Material Twisted/Bent 9 9
Device Contamination with Body Fluid 8 8
Component Missing 8 8
Cut In Material 7 7
Inaccurate Synchronization 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8470 8471
No Clinical Signs, Symptoms or Conditions 1546 1546
Unspecified Infection 1523 1523
Death 502 503
No Consequences Or Impact To Patient 270 270
Shock from Patient Lead(s) 245 245
Syncope 229 229
Insufficient Information 204 204
Muscle Stimulation 192 192
Dizziness 187 187
No Patient Involvement 169 169
Fatigue 165 165
Bradycardia 134 134
Dyspnea 133 133
Pericardial Effusion 130 130
Pocket Erosion 129 129
Cardiac Arrest 122 122
Discomfort 115 115
No Information 114 114
Arrhythmia 114 114
No Code Available 113 113
Cardiac Perforation 108 108
Chest Pain 107 107
Complaint, Ill-Defined 106 106
Hematoma 104 104
Pain 83 83
Pneumothorax 80 80
Cardiac Tamponade 79 79
Erosion 71 71
Syncope/Fainting 69 69
Endocarditis 68 68
Sepsis 67 67
Twiddlers Syndrome 63 63
Palpitations 60 60
Atrial Fibrillation 56 56
Ventricular Fibrillation 54 54
Ventricular Tachycardia 54 54
Undesired Nerve Stimulation 52 52
Swelling 49 49
Tachycardia 49 49
Fever 41 41
Fall 38 38
Bacterial Infection 35 35
Low Blood Pressure/ Hypotension 34 34
Complete Heart Block 34 34
Perforation 31 31
Heart Failure 30 30
Stroke/CVA 29 29
Wound Dehiscence 28 28
Hemothorax 25 25
Weakness 25 25
Exit Block 24 24
Pleural Effusion 23 23
Occlusion 23 23
Heart Failure/Congestive Heart Failure 21 21
Vascular Dissection 20 20
Electric Shock 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Myocardial Infarction 18 18
Inflammation 17 17
Septic Shock 17 17
Thrombosis 17 17
Device Overstimulation of Tissue 16 16
Failure of Implant 16 16
Fainting 16 16
Atrial Flutter 16 16
Hemorrhage/Bleeding 15 15
Nausea 15 15
Loss of consciousness 15 15
Asystole 14 14
Tricuspid Valve Insufficiency/ Regurgitation 14 14
Pulmonary Embolism 14 14
Chest Tightness/Pressure 13 13
Hypersensitivity/Allergic reaction 11 11
Non specific EKG/ECG Changes 11 11
Purulent Discharge 11 11
Staphylococcus Aureus 11 11
Thrombus 11 11
Twitching 10 10
Obstruction/Occlusion 10 10
Thrombosis/Thrombus 10 10
Heart Block 9 9
Edema 9 9
High Blood Pressure/ Hypertension 9 9
Chills 8 8
Shock 8 8
Post Operative Wound Infection 8 8
Malaise 8 8
Sudden Cardiac Death 8 8
Respiratory Failure 7 7
Blood Loss 7 7
Injury 7 7
Collapse 7 7
Swelling/ Edema 7 7
Presyncope 6 6
Cardiogenic Shock 6 6
Diminished Pulse Pressure 6 6
Foreign Body In Patient 6 6
Skin Irritation 6 6
Great Vessel Perforation 6 6

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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