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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 11

MDR Year MDR Reports MDR Events
2017 1047 1047
2018 2073 2073
2019 1801 1801
2020 547 547
2021 580 580
2022 721 721

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1800 1800
Device Dislodged or Dislocated 797 797
Over-Sensing 693 693
Signal Artifact/Noise 567 567
Failure to Capture 509 509
High Capture Threshold 384 384
Premature Discharge of Battery 331 331
High impedance 282 282
Pacemaker Found in Back-Up Mode 228 228
Pacing Problem 213 213
Failure to Interrogate 207 207
Under-Sensing 198 198
Break 197 197
Appropriate Term/Code Not Available 192 192
Device Sensing Problem 190 190
Fracture 174 174
Low impedance 158 158
Inappropriate/Inadequate Shock/Stimulation 147 147
Capturing Problem 146 146
Impedance Problem 139 139
Failure to Sense 132 132
No Pacing 110 110
Data Problem 93 93
Decreased Sensitivity 92 92
Mechanical Problem 88 88
Incorrect Measurement 69 69
Connection Problem 69 69
Misconnection 64 64
Intermittent Capture 56 56
Battery Problem 52 52
Unstable Capture Threshold 49 49
Failure to Disconnect 47 47
Loose or Intermittent Connection 43 43
Difficult to Remove 43 43
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
Low Sensing Threshold 36 36
Retraction Problem 36 36
Defective Device 35 35
Insufficient Information 33 33
Inappropriate or Unexpected Reset 32 32
Electrical /Electronic Property Problem 28 28
Material Integrity Problem 27 27
Incorrect, Inadequate or Imprecise Result or Readings 26 26
Premature Elective Replacement Indicator 24 24
Positioning Failure 24 24
Wireless Communication Problem 23 23
Electromagnetic Interference 22 22
Device Displays Incorrect Message 22 22
Interrogation Problem 20 20
Telemetry Discrepancy 19 19
Invalid Sensing 18 18
Reset Problem 17 17
Activation, Positioning or Separation Problem 16 16
Ambient Noise Problem 14 14
Fitting 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
Unable to Obtain Readings 9 9
Pacing Intermittently 9 9
Pacing Asynchronously 9 9
Defibrillation/Stimulation Problem 9 9
Material Twisted/Bent 9 9
Protective Measures Problem 9 9
Material Deformation 8 8
No Apparent Adverse Event 8 8
Contamination of Device Ingredient or Reagent 8 8
Detachment of Device or Device Component 7 7
Pacing Inadequately 7 7
Electronic Property Issue 7 7
Incorrect Device Or Component Shipped 6 6
Degraded 6 6
High Sensing Threshold 6 6
Inaccurate Synchronization 6 6
Device Contamination with Body Fluid 6 6
Therapy Delivered to Incorrect Body Area 5 5
Device Markings/Labelling Problem 5 5
Device-Device Incompatibility 5 5
Failure to Deliver Shock/Stimulation 5 5
Failure to Charge 5 5
No Device Output 5 5
Pocket Stimulation 5 5
Failure to Transmit Record 5 5
Device Contamination with Chemical or Other Material 5 5
Missing Test Results 5 5
Unauthorized Access to Computer System 4 4
Noise, Audible 4 4
Difficult to Interrogate 4 4
Detachment Of Device Component 4 4
Difficult or Delayed Positioning 4 4
Display or Visual Feedback Problem 4 4
Delayed Charge Time 4 4
Application Program Version or Upgrade Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2915 2915
Unspecified Infection 1146 1146
No Clinical Signs, Symptoms or Conditions 895 895
Death 340 341
No Consequences Or Impact To Patient 177 177
Shock from Patient Lead(s) 135 135
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
Hematoma 58 58
Cardiac Arrest 57 57
Pneumothorax 57 57
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
Swelling 38 38
Atrial Fibrillation 38 38
Fever 37 37
Fatigue 35 35
Undesired Nerve Stimulation 35 35
No Patient Involvement 33 33
Low Blood Pressure/ Hypotension 30 30
Tachycardia 29 29
Ventricular Tachycardia 29 29
Ventricular Fibrillation 28 28
Complete Heart Block 27 27
Insufficient Information 27 27
Perforation 25 25
Wound Dehiscence 25 25
Fall 22 22
Occlusion 21 21
Heart Failure 20 20
Weakness 17 17
Hemothorax 16 16
Pleural Effusion 15 15
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
Failure of Implant 9 9
Nausea 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Electric Shock 9 9
Obstruction/Occlusion 9 9
Chest Tightness/Pressure 8 8
Myocardial Infarction 8 8
Septic Shock 8 8
High Blood Pressure/ Hypertension 8 8
Non specific EKG/ECG Changes 8 8
Edema 8 8
Thrombus 7 7
Sudden Cardiac Death 7 7
Heart Failure/Congestive Heart Failure 7 7
Asystole 6 6
Respiratory Failure 6 6
Great Vessel Perforation 6 6
Chills 6 6
Pulmonary Embolism 6 6
Atrial Flutter 6 6
Cellulitis 6 6
Purulent Discharge 6 6
Fainting 5 5
Erythema 5 5
Hypersensitivity/Allergic reaction 5 5
Staphylococcus Aureus 5 5
Post Operative Wound Infection 5 5
Diminished Pulse Pressure 5 5
Heart Block 5 5
Tricuspid Valve Insufficiency/ Regurgitation 5 5
Twiddlers Syndrome 4 4
Thrombosis/Thrombus 4 4
Loss of consciousness 4 4
Seizures 4 4
Therapeutic Effects, Unexpected 4 4
Mitral Regurgitation 4 4
Perforation of Vessels 4 4
Vomiting 4 4
Headache 4 4
Cardiomyopathy 4 4
Embolism 3 3

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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