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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)
2018 2019 2020 2021 2022 2023
45 19 23 20 14 16

MDR Year MDR Reports MDR Events
2018 2071 2071
2019 1799 1799
2020 546 546
2021 560 560
2022 784 784
2023 609 609

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1681 1681
Device Dislodged or Dislocated 629 629
Over-Sensing 622 622
Signal Artifact/Noise 542 542
Failure to Capture 437 437
Premature Discharge of Battery 336 336
High Capture Threshold 330 330
High impedance 261 261
Pacemaker Found in Back-Up Mode 248 248
Failure to Interrogate 214 214
Pacing Problem 210 210
Under-Sensing 198 198
Appropriate Term/Code Not Available 185 185
Device Sensing Problem 172 172
Break 161 161
Impedance Problem 153 153
Fracture 150 150
Inappropriate/Inadequate Shock/Stimulation 137 137
Low impedance 136 136
Capturing Problem 124 124
No Pacing 113 113
Failure to Sense 95 95
Data Problem 94 94
Insufficient Information 79 79
Incorrect Measurement 79 79
Decreased Sensitivity 74 74
Mechanical Problem 69 69
Connection Problem 65 65
Misconnection 61 61
Failure to Disconnect 55 55
Battery Problem 53 53
Loose or Intermittent Connection 52 52
Intermittent Capture 44 44
Unstable Capture Threshold 40 40
Difficult to Remove 39 39
Defective Device 39 39
Communication or Transmission Problem 38 38
Positioning Problem 38 38
Output Problem 37 37
Incorrect, Inadequate or Imprecise Result or Readings 37 37
Difficult to Insert 36 36
Low Sensing Threshold 34 34
Inappropriate or Unexpected Reset 30 30
Electrical /Electronic Property Problem 30 30
Wireless Communication Problem 26 26
Retraction Problem 25 25
Electromagnetic Interference 23 23
Material Integrity Problem 22 22
Interrogation Problem 21 21
Premature Elective Replacement Indicator 19 19
Telemetry Discrepancy 18 18
Use of Device Problem 17 17
Device Displays Incorrect Message 16 16
Fitting Problem 14 14
Device Operates Differently Than Expected 14 14
Therapeutic or Diagnostic Output Failure 14 14
Migration 13 13
Sensing Intermittently 12 12
Separation Failure 12 12
Pacing Asynchronously 12 12
Positioning Failure 10 10
High Sensing Threshold 10 10
Invalid Sensing 10 10
No Apparent Adverse Event 10 10
Material Twisted/Bent 9 9
Noise, Audible 9 9
Activation, Positioning or Separation Problem 9 9
Contamination of Device Ingredient or Reagent 9 9
Migration or Expulsion of Device 9 9
Pacing Intermittently 9 9
Display or Visual Feedback Problem 8 8
Battery Problem: High Impedance 8 8
Reset Problem 8 8
Detachment of Device or Device Component 7 7
Inaccurate Synchronization 7 7
Defibrillation/Stimulation Problem 6 6
Incorrect Device Or Component Shipped 6 6
Failure to Deliver Shock/Stimulation 6 6
Therapy Delivered to Incorrect Body Area 6 6
Unable to Obtain Readings 6 6
Pacing Inadequately 5 5
Nonstandard Device 5 5
Failure to Charge 5 5
Device-Device Incompatibility 5 5
Protective Measures Problem 5 5
Unauthorized Access to Computer System 4 4
Missing Test Results 4 4
Material Deformation 4 4
Device Markings/Labelling Problem 4 4
Ambient Noise Problem 4 4
Application Program Version or Upgrade Problem 4 4
Device Contamination with Body Fluid 4 4
Device Alarm System 4 4
Degraded 4 4
Difficult or Delayed Positioning 4 4
Difficult to Interrogate 4 4
No Device Output 4 4
Failure to Transmit Record 4 4
Incorrect Interpretation of Signal 4 4
Failure to Advance 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2344 2344
No Clinical Signs, Symptoms or Conditions 1209 1209
Unspecified Infection 1063 1063
Death 251 251
Insufficient Information 165 165
No Consequences Or Impact To Patient 162 162
Shock from Patient Lead(s) 122 122
Dizziness 113 113
Pocket Erosion 92 92
Arrhythmia 86 86
Syncope 85 85
Pericardial Effusion 85 85
No Information 75 75
Dyspnea 75 75
Chest Pain 66 66
Discomfort 60 60
Bradycardia 59 59
Syncope/Fainting 59 59
Hematoma 56 56
Cardiac Arrest 52 52
Twiddlers Syndrome 50 50
Cardiac Perforation 50 50
Muscle Stimulation 46 46
Pneumothorax 44 44
No Code Available 44 44
Endocarditis 42 42
Erosion 41 41
Cardiac Tamponade 41 41
Complaint, Ill-Defined 40 40
Sepsis 37 37
Pain 36 36
Undesired Nerve Stimulation 33 33
Palpitations 32 32
Swelling 31 31
Fatigue 31 31
Atrial Fibrillation 29 29
Fever 27 27
Tachycardia 25 25
No Patient Involvement 25 25
Ventricular Fibrillation 23 23
Wound Dehiscence 23 23
Low Blood Pressure/ Hypotension 21 21
Fall 19 19
Bacterial Infection 19 19
Ventricular Tachycardia 19 19
Perforation 18 18
Complete Heart Block 18 18
Pleural Effusion 15 15
Stroke/CVA 14 14
Hemothorax 14 14
Electric Shock 13 13
Heart Failure/Congestive Heart Failure 13 13
Tricuspid Valve Insufficiency/ Regurgitation 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Vascular Dissection 12 12
Failure of Implant 12 12
Inflammation 11 11
Device Overstimulation of Tissue 11 11
Occlusion 11 11
Weakness 11 11
Septic Shock 10 10
Hemorrhage/Bleeding 10 10
Asystole 10 10
Heart Failure 9 9
Obstruction/Occlusion 9 9
Purulent Discharge 8 8
Non specific EKG/ECG Changes 8 8
Thrombosis/Thrombus 8 8
Edema 7 7
High Blood Pressure/ Hypertension 7 7
Chest Tightness/Pressure 7 7
Thrombosis 7 7
Post Operative Wound Infection 6 6
Twitching 6 6
Myocardial Infarction 6 6
Nausea 6 6
Pulmonary Embolism 6 6
Foreign Body In Patient 6 6
Diminished Pulse Pressure 5 5
Exit Block 5 5
Respiratory Failure 5 5
Cellulitis 5 5
Loss of consciousness 5 5
Malaise 5 5
Thrombus 5 5
Staphylococcus Aureus 5 5
Therapeutic Effects, Unexpected 4 4
Vomiting 4 4
Chills 4 4
Great Vessel Perforation 4 4
Mitral Regurgitation 4 4
Hypersensitivity/Allergic reaction 4 4
Presyncope 4 4
Heart Block 4 4
Twiddlers Syndrome 4 4
Swelling/ Edema 4 4
Pericarditis 3 3
Fluid Discharge 3 3
Headache 3 3
Muscle Weakness 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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