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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 620 620
2025 528 528

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 1014 1014
Mechanical Problem 707 707
No Display/Image 678 678
Display or Visual Feedback Problem 423 423
Calibration Problem 418 418
Output Problem 334 334
Device Sensing Problem 251 251
Unexpected Shutdown 239 239
Failure to Power Up 237 237
Use of Device Problem 224 224
No Device Output 221 221
Break 211 211
Material Integrity Problem 138 138
Corroded 126 126
Component Missing 121 121
Battery Problem 108 108
Contamination 81 81
Electrical /Electronic Property Problem 79 79
Failure to Capture 74 74
Loose or Intermittent Connection 58 58
Crack 56 56
Capturing Problem 44 44
Power Problem 40 40
Moisture Damage 27 27
Pacing Intermittently 25 25
Insufficient Information 25 25
Under-Sensing 21 21
Adverse Event Without Identified Device or Use Problem 19 19
Pacing Problem 19 19
Failure to Sense 18 18
Intermittent Capture 16 16
Output below Specifications 15 15
Failure to Shut Off 14 14
Inadequate User Interface 12 12
Output above Specifications 10 10
Blocked Connection 9 9
Over-Sensing 8 8
Failure to Calibrate 7 7
Device Difficult to Program or Calibrate 7 7
Contamination /Decontamination Problem 6 6
Difficult to Insert 6 6
Failure of Device to Self-Test 6 6
Premature Discharge of Battery 6 6
Sensing Intermittently 6 6
Data Problem 5 5
Noise, Audible 5 5
Circuit Failure 5 5
Defective Device 5 5
Operating System Becomes Nonfunctional 5 5
Key or Button Unresponsive/not Working 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3621 3621
No Patient Involvement 727 727
No Known Impact Or Consequence To Patient 126 126
No Consequences Or Impact To Patient 97 97
Cardiac Arrest 45 45
Ventricular Fibrillation 36 36
Asystole 27 27
Arrhythmia 22 22
Tachycardia 16 16
Heart Block 10 10
Loss of consciousness 10 10
Bradycardia 10 10
Insufficient Information 7 7
Superficial (First Degree) Burn 5 5
Low Blood Pressure/ Hypotension 5 5
Non specific EKG/ECG Changes 4 4
R On T Phenomenon 4 4
Erythema 3 3
Injury 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Information 3 3
Abrasion 2 2
Pericardial Effusion 2 2
Blister 2 2
Low Oxygen Saturation 2 2
Aspiration/Inhalation 2 2
Syncope/Fainting 2 2
Skin Inflammation/ Irritation 2 2
Discomfort 2 2
Dizziness 2 2
Unspecified Heart Problem 2 2
Pneumonia 2 2
Diaphoresis 2 2
Bruise/Contusion 1 1
Respiratory Failure 1 1
Atrial Flutter 1 1
Hemorrhage/Bleeding 1 1
Sweating 1 1
Drug Resistant Bacterial Infection 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
Nausea 1 1
Sepsis 1 1
Dyspnea 1 1
Cardiopulmonary Arrest 1 1
Septic Shock 1 1

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