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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pulse-generator, pacemaker, external
Regulation Description External pacemaker pulse generator.
Product CodeDTE
Regulation Number 870.3600
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LIFETECH CARDIO MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOLO PACE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1092 1092
2021 899 899
2022 833 833
2023 650 650
2024 621 621
2025 142 142

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 977 977
Mechanical Problem 668 668
No Display/Image 618 618
Display or Visual Feedback Problem 391 391
Calibration Problem 380 380
Output Problem 287 287
Device Sensing Problem 223 223
Failure to Power Up 218 218
Unexpected Shutdown 211 211
Use of Device Problem 208 208
Break 201 201
No Device Output 189 189
Material Integrity Problem 135 135
Corroded 125 125
Component Missing 115 115
Battery Problem 90 90
Contamination 81 81
Electrical /Electronic Property Problem 73 73
Failure to Capture 63 63
Loose or Intermittent Connection 53 53
Crack 46 46
Capturing Problem 42 42
Power Problem 36 36
Insufficient Information 24 24
Moisture Damage 24 24
Pacing Intermittently 21 21
Failure to Sense 18 18
Adverse Event Without Identified Device or Use Problem 18 18
Failure to Shut Off 13 13
Pacing Problem 13 13
Under-Sensing 12 12
Inadequate User Interface 12 12
Intermittent Capture 12 12
Output below Specifications 9 9
Blocked Connection 8 8
Output above Specifications 8 8
Failure to Calibrate 7 7
Over-Sensing 7 7
Contamination /Decontamination Problem 6 6
Difficult to Insert 6 6
Device Difficult to Program or Calibrate 6 6
Data Problem 5 5
Operating System Becomes Nonfunctional 5 5
Circuit Failure 5 5
Noise, Audible 5 5
Application Program Freezes, Becomes Nonfunctional 4 4
Failure of Device to Self-Test 4 4
No Pacing 4 4
Defective Device 4 4
Sensing Intermittently 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3259 3259
No Patient Involvement 727 727
No Known Impact Or Consequence To Patient 126 126
No Consequences Or Impact To Patient 97 97
Cardiac Arrest 41 41
Ventricular Fibrillation 32 32
Asystole 21 21
Arrhythmia 17 17
Tachycardia 16 16
Heart Block 9 9
Loss of consciousness 9 9
Bradycardia 6 6
Insufficient Information 5 5
Non specific EKG/ECG Changes 4 4
Superficial (First Degree) Burn 4 4
R On T Phenomenon 4 4
Low Blood Pressure/ Hypotension 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Information 3 3
Injury 3 3
Erythema 3 3
Diaphoresis 2 2
Low Oxygen Saturation 2 2
Dizziness 2 2
Skin Inflammation/ Irritation 2 2
Abrasion 2 2
Pericardial Effusion 2 2
Blister 2 2
Pneumonia 2 2
Bruise/Contusion 1 1
Respiratory Failure 1 1
Atrial Flutter 1 1
Hemorrhage/Bleeding 1 1
Unspecified Heart Problem 1 1
Ectopic Heartbeat 1 1
Skin Tears 1 1
Hypoxia 1 1
Shaking/Tremors 1 1
Sudden Cardiac Death 1 1
Stenosis 1 1
Dyspnea 1 1
Cardiopulmonary Arrest 1 1
Discomfort 1 1
Septic Shock 1 1
Cardiac Perforation 1 1
Pallor 1 1
Burn(s) 1 1
Cardiac Tamponade 1 1
Skin Discoloration 1 1
Device Overstimulation of Tissue 1 1

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