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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
SHENZHEN LIFETECH CARDIO MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOLO PACE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 899 899
2022 833 835
2023 650 651
2024 620 620
2025 643 643
2026 202 202

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 625 625
Connection Problem 613 613
Mechanical Problem 593 593
Calibration Problem 383 383
Display or Visual Feedback Problem 351 351
Output Problem 340 340
Device Sensing Problem 238 238
Unexpected Shutdown 220 220
No Device Output 208 208
Use of Device Problem 200 200
Failure to Power Up 198 198
Break 166 167
Material Integrity Problem 136 136
Corroded 115 115
Battery Problem 98 98
Component Missing 87 87
Contamination 81 81
Electrical /Electronic Property Problem 76 76
Failure to Capture 69 69
Crack 56 56
Loose or Intermittent Connection 44 44
Capturing Problem 35 35
Power Problem 33 33
Under-Sensing 25 25
Pacing Problem 24 24
Pacing Intermittently 20 20
Moisture Damage 16 16
Over-Sensing 16 16
Adverse Event Without Identified Device or Use Problem 16 17
Output below Specifications 16 16
Failure to Sense 14 14
Intermittent Capture 12 13
Premature Discharge of Battery 9 9
Output above Specifications 9 9
Failure to Shut Off 8 8
Failure of Device to Self-Test 6 6
Failure to Calibrate 6 6
Sensing Intermittently 6 6
Inadequate User Interface 5 5
Key or Button Unresponsive/not Working 5 5
Blocked Connection 4 4
Operating System Becomes Nonfunctional 4 4
Circuit Failure 4 4
Device Difficult to Program or Calibrate 3 3
Insufficient Information 3 3
Impedance Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Contamination /Decontamination Problem 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
No Pacing 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3676 3677
Cardiac Arrest 40 40
Ventricular Fibrillation 31 31
Asystole 31 31
Arrhythmia 25 26
Tachycardia 17 17
Bradycardia 13 13
Heart Block 8 8
Insufficient Information 8 8
Loss of consciousness 7 7
Superficial (First Degree) Burn 6 6
Low Blood Pressure/ Hypotension 5 6
Atrial Flutter 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 4
Erythema 3 3
Non specific EKG/ECG Changes 2 2
Syncope/Fainting 2 2
Diaphoresis 2 2
Low Oxygen Saturation 2 2
Dizziness 2 2
Skin Inflammation/ Irritation 2 2
Aspiration/Inhalation 2 2
Abrasion 2 2
Multiple Organ Failure 2 2
Pericardial Effusion 2 3
Blister 2 2
Unspecified Heart Problem 2 2
Discomfort 2 2
Pneumonia 2 2
Bruise/Contusion 1 1
Respiratory Failure 1 1
Aortic Valve Insufficiency/ Regurgitation 1 1
Hemorrhage/Bleeding 1 1
Ectopic Heartbeat 1 1
Hypoxia 1 1
Swelling/ Edema 1 1
Sudden Cardiac Death 1 1
Stenosis 1 1
Shock 1 1
Pulmonary Edema 1 1
Dyspnea 1 1
Septic Shock 1 1
Foreign Body In Patient 1 1
Cardiac Perforation 1 1
Pallor 1 1
Burn(s) 1 1
Angina 1 1
Cardiac Tamponade 1 1
Skin Discoloration 1 1
Device Overstimulation of Tissue 1 1

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