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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 2

MDR Year MDR Reports MDR Events
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 1136 1136
Over-Sensing 487 487
Signal Artifact/Noise 396 396
Premature Discharge of Battery 325 325
Device Dislodged or Dislocated 304 304
Failure to Capture 277 277
High Capture Threshold 234 234
Pacemaker Found in Back-Up Mode 208 208
Failure to Interrogate 206 206
High impedance 194 194
Pacing Problem 192 192
Under-Sensing 166 166
Appropriate Term/Code Not Available 155 155
Impedance Problem 135 135
Inappropriate/Inadequate Shock/Stimulation 127 127
Device Sensing Problem 120 120
Fracture 116 116
No Pacing 108 108
Break 106 106
Capturing Problem 97 97
Low impedance 91 91
Data Problem 85 85
Incorrect Measurement 83 83
Insufficient Information 71 71
Failure to Disconnect 64 64
Loose or Intermittent Connection 59 59
Decreased Sensitivity 58 58
Mechanical Problem 52 52
Misconnection 50 50
Connection Problem 50 50
Battery Problem 45 45
Defective Device 45 45
Incorrect, Inadequate or Imprecise Result or Readings 40 40
Difficult to Remove 39 39
Positioning Problem 38 38
Electrical /Electronic Property Problem 36 36
Unstable Capture Threshold 32 32
Intermittent Capture 30 30
Wireless Communication Problem 28 28
Communication or Transmission Problem 26 26
Failure to Sense 25 25
Interrogation Problem 25 25
Output Problem 24 24
Inappropriate or Unexpected Reset 22 22
Electromagnetic Interference 20 20
Low Sensing Threshold 19 19
Use of Device Problem 18 18
Material Integrity Problem 16 16
Therapeutic or Diagnostic Output Failure 14 14
No Apparent Adverse Event 13 13
Telemetry Discrepancy 13 13
Pacing Asynchronously 13 13
Premature Elective Replacement Indicator 13 13
Difficult to Insert 12 12
Contamination of Device Ingredient or Reagent 11 11
Migration 11 11
Activation, Positioning or Separation Problem 9 9
Separation Failure 9 9
Display or Visual Feedback Problem 8 8
Retraction Problem 8 8
Therapy Delivered to Incorrect Body Area 7 7
Inaccurate Synchronization 7 7
Pacing Intermittently 7 7
Fitting Problem 7 7
Detachment of Device or Device Component 7 7
Reset Problem 7 7
Noise, Audible 7 7
Packaging Problem 6 6
Failure to Read Input Signal 6 6
Sensing Intermittently 6 6
Failure to Charge 6 6
Failure to Deliver Shock/Stimulation 5 5
Material Twisted/Bent 5 5
Battery Problem: High Impedance 5 5
Device-Device Incompatibility 5 5
Device Markings/Labelling Problem 4 4
Electromagnetic Compatibility Problem 4 4
High Sensing Threshold 4 4
Device Contamination with Body Fluid 4 4
Device Displays Incorrect Message 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Unauthorized Access to Computer System 4 4
Protective Measures Problem 4 4
Unable to Obtain Readings 4 4
Migration or Expulsion of Device 4 4
Pacing Inadequately 3 3
Off-Label Use 3 3
Defibrillation/Stimulation Problem 3 3
Difficult or Delayed Positioning 3 3
Device Alarm System 3 3
Nonstandard Device 3 3
Missing Test Results 3 3
Unexpected Therapeutic Results 3 3
Environmental Compatibility Problem 3 3
Delayed Charge Time 3 3
Improper or Incorrect Procedure or Method 2 2
Component Missing 2 2
Malposition of Device 2 2
Application Program Version or Upgrade Problem 2 2
Failure to Advance 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1546 1546
No Known Impact Or Consequence To Patient 1276 1276
Unspecified Infection 706 706
Insufficient Information 201 201
No Consequences Or Impact To Patient 129 129
Death 123 123
Shock from Patient Lead(s) 110 110
Arrhythmia 83 83
Dizziness 83 83
Pocket Erosion 72 72
Syncope/Fainting 68 68
Discomfort 51 51
Syncope 51 51
Dyspnea 49 49
Bradycardia 42 42
Cardiac Arrest 36 36
Hematoma 35 35
Pericardial Effusion 35 35
No Information 34 34
Erosion 33 33
Cardiac Tamponade 32 32
Sepsis 31 31
Cardiac Perforation 30 30
Endocarditis 29 29
Fatigue 29 29
No Code Available 29 29
Undesired Nerve Stimulation 28 28
Pain 28 28
Tachycardia 28 28
Chest Pain 27 27
Bacterial Infection 26 26
Pneumothorax 25 25
Twiddlers Syndrome 23 23
Muscle Stimulation 21 21
Heart Failure/Congestive Heart Failure 21 21
Ventricular Fibrillation 19 19
Electric Shock 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Swelling 16 16
Wound Dehiscence 15 15
Atrial Fibrillation 15 15
Fall 14 14
Device Overstimulation of Tissue 14 14
Asystole 14 14
Tricuspid Valve Insufficiency/ Regurgitation 14 14
Stroke/CVA 13 13
Hemothorax 12 12
Palpitations 12 12
Perforation 11 11
Low Blood Pressure/ Hypotension 11 11
Failure of Implant 11 11
Hemorrhage/Bleeding 10 10
No Patient Involvement 10 10
Vascular Dissection 10 10
Thrombosis/Thrombus 10 10
Heart Block 9 9
Complaint, Ill-Defined 9 9
Obstruction/Occlusion 9 9
Fever 9 9
Purulent Discharge 9 9
Pulmonary Embolism 9 9
Pleural Effusion 8 8
Occlusion 8 8
Myocardial Infarction 8 8
Complete Heart Block 8 8
Heart Failure 8 8
Non specific EKG/ECG Changes 7 7
Swelling/ Edema 7 7
Presyncope 6 6
Foreign Body In Patient 6 6
Edema 6 6
Hypersensitivity/Allergic reaction 6 6
Twitching 6 6
Septic Shock 6 6
Loss of consciousness 6 6
Post Operative Wound Infection 5 5
Ventricular Tachycardia 5 5
Inflammation 5 5
High Blood Pressure/ Hypertension 4 4
Laceration(s) 4 4
Mitral Regurgitation 4 4
Abscess 4 4
Atrial Flutter 4 4
Malaise 4 4
Respiratory Failure 4 4
Pericarditis 4 4
Twiddlers Syndrome 4 4
Drug Resistant Bacterial Infection 3 3
Weakness 3 3
Burning Sensation 3 3
Great Vessel Perforation 3 3
Rupture 3 3
Cardiogenic Shock 3 3
Thrombosis 3 3
Muscle Weakness 3 3
Cyanosis 3 3
Foreign Body Reaction 3 3
Bone Fracture(s) 2 2
Headache 2 2
Fistula 2 2

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