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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)
2017 2018 2019 2020 2021 2022
52 45 19 23 20 12

MDR Year MDR Reports MDR Events
2017 1047 1047
2018 2073 2073
2019 1801 1801
2020 547 547
2021 580 580
2022 785 785

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1814 1814
Device Dislodged or Dislocated 798 798
Over-Sensing 699 699
Signal Artifact/Noise 568 568
Failure to Capture 511 511
High Capture Threshold 386 386
Premature Discharge of Battery 337 337
High impedance 286 286
Pacemaker Found in Back-Up Mode 232 232
Pacing Problem 215 215
Failure to Interrogate 212 212
Under-Sensing 201 201
Break 197 197
Appropriate Term/Code Not Available 196 196
Device Sensing Problem 192 192
Fracture 177 177
Low impedance 160 160
Inappropriate/Inadequate Shock/Stimulation 152 152
Capturing Problem 149 149
Impedance Problem 144 144
Failure to Sense 132 132
No Pacing 112 112
Decreased Sensitivity 93 93
Data Problem 93 93
Mechanical Problem 90 90
Incorrect Measurement 70 70
Connection Problem 69 69
Misconnection 64 64
Intermittent Capture 56 56
Battery Problem 52 52
Unstable Capture Threshold 49 49
Failure to Disconnect 49 49
Loose or Intermittent Connection 45 45
Difficult to Remove 44 44
Positioning Problem 43 43
Difficult to Insert 41 41
Output Problem 39 39
Communication or Transmission Problem 37 37
Device Operates Differently Than Expected 37 37
Defective Device 36 36
Retraction Problem 36 36
Low Sensing Threshold 36 36
Insufficient Information 34 34
Inappropriate or Unexpected Reset 32 32
Electrical /Electronic Property Problem 29 29
Incorrect, Inadequate or Imprecise Result or Readings 28 28
Material Integrity Problem 27 27
Premature Elective Replacement Indicator 24 24
Positioning Failure 24 24
Electromagnetic Interference 23 23
Wireless Communication Problem 23 23
Device Displays Incorrect Message 22 22
Interrogation Problem 21 21
Telemetry Discrepancy 19 19
Invalid Sensing 18 18
Activation, Positioning or Separation Problem 17 17
Reset Problem 17 17
Fitting Problem 14 14
Ambient Noise Problem 14 14
Use of Device Problem 13 13
Migration 13 13
Sensing Intermittently 12 12
Separation Failure 12 12
Battery Problem: High Impedance 11 11
Migration or Expulsion of Device 10 10
Pacing Intermittently 9 9
Material Twisted/Bent 9 9
Protective Measures Problem 9 9
Unable to Obtain Readings 9 9
Defibrillation/Stimulation Problem 9 9
Pacing Asynchronously 9 9
No Apparent Adverse Event 8 8
Contamination of Device Ingredient or Reagent 8 8
Material Deformation 8 8
Electronic Property Issue 7 7
Pacing Inadequately 7 7
Detachment of Device or Device Component 7 7
Degraded 6 6
Inaccurate Synchronization 6 6
High Sensing Threshold 6 6
Incorrect Device Or Component Shipped 6 6
Device Contamination with Body Fluid 6 6
Device-Device Incompatibility 5 5
Therapy Delivered to Incorrect Body Area 5 5
Pocket Stimulation 5 5
Device Contamination with Chemical or Other Material 5 5
Missing Test Results 5 5
Failure to Deliver Shock/Stimulation 5 5
Failure to Charge 5 5
No Device Output 5 5
Failure to Transmit Record 5 5
Device Markings/Labelling Problem 5 5
Unauthorized Access to Computer System 4 4
Delayed Charge Time 4 4
Difficult or Delayed Positioning 4 4
Display or Visual Feedback Problem 4 4
Noise, Audible 4 4
Incorrect Interpretation of Signal 4 4
Application Program Version or Upgrade Problem 4 4
Difficult to Interrogate 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2915 2915
Unspecified Infection 1147 1147
No Clinical Signs, Symptoms or Conditions 945 945
Death 340 341
No Consequences Or Impact To Patient 177 177
Shock from Patient Lead(s) 140 140
Dizziness 115 115
Pericardial Effusion 108 108
Syncope 105 105
No Information 95 95
Pocket Erosion 90 90
Dyspnea 88 88
Arrhythmia 85 85
Chest Pain 83 83
Cardiac Perforation 78 78
Muscle Stimulation 67 67
Bradycardia 66 66
Discomfort 62 62
Cardiac Arrest 58 58
Pneumothorax 58 58
Hematoma 58 58
Twiddlers Syndrome 57 57
Cardiac Tamponade 54 54
Endocarditis 49 49
No Code Available 49 49
Complaint, Ill-Defined 48 48
Erosion 46 46
Syncope/Fainting 45 45
Pain 43 43
Sepsis 41 41
Palpitations 39 39
Atrial Fibrillation 38 38
Swelling 38 38
Fever 37 37
Fatigue 35 35
Undesired Nerve Stimulation 35 35
No Patient Involvement 33 33
Tachycardia 30 30
Insufficient Information 30 30
Low Blood Pressure/ Hypotension 30 30
Ventricular Tachycardia 29 29
Ventricular Fibrillation 28 28
Complete Heart Block 27 27
Perforation 26 26
Wound Dehiscence 25 25
Fall 23 23
Occlusion 21 21
Heart Failure 20 20
Weakness 17 17
Pleural Effusion 16 16
Hemothorax 16 16
Inflammation 14 14
Stroke/CVA 13 13
Exit Block 13 13
Vascular Dissection 12 12
Bacterial Infection 11 11
Device Overstimulation of Tissue 11 11
Thrombosis 10 10
Hemorrhage/Bleeding 10 10
Nausea 9 9
Electric Shock 9 9
Obstruction/Occlusion 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Failure of Implant 9 9
High Blood Pressure/ Hypertension 8 8
Non specific EKG/ECG Changes 8 8
Chest Tightness/Pressure 8 8
Septic Shock 8 8
Myocardial Infarction 8 8
Edema 8 8
Asystole 7 7
Heart Block 7 7
Thrombus 7 7
Heart Failure/Congestive Heart Failure 7 7
Sudden Cardiac Death 7 7
Tricuspid Valve Insufficiency/ Regurgitation 6 6
Purulent Discharge 6 6
Cellulitis 6 6
Great Vessel Perforation 6 6
Pulmonary Embolism 6 6
Atrial Flutter 6 6
Chills 6 6
Respiratory Failure 6 6
Hypersensitivity/Allergic reaction 5 5
Thrombosis/Thrombus 5 5
Diminished Pulse Pressure 5 5
Post Operative Wound Infection 5 5
Staphylococcus Aureus 5 5
Erythema 5 5
Fainting 5 5
Therapeutic Effects, Unexpected 4 4
Perforation of Vessels 4 4
Seizures 4 4
Pneumonia 4 4
Headache 4 4
Vomiting 4 4
Twiddlers Syndrome 4 4
Mitral Regurgitation 4 4
Cardiomyopathy 4 4
Loss of consciousness 4 4

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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