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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 81 81

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 608 608
No Display/Image 604 604
Mechanical Problem 584 584
Calibration Problem 370 370
Display or Visual Feedback Problem 344 344
Output Problem 322 322
Device Sensing Problem 231 231
Unexpected Shutdown 209 209
No Device Output 199 199
Failure to Power Up 197 197
Use of Device Problem 195 195
Break 163 164
Material Integrity Problem 135 135
Corroded 115 115
Battery Problem 94 94
Component Missing 87 87
Contamination 81 81
Electrical /Electronic Property Problem 72 72
Failure to Capture 65 65
Crack 55 55
Loose or Intermittent Connection 43 43
Capturing Problem 35 35
Power Problem 33 33
Pacing Problem 22 22
Under-Sensing 20 20
Pacing Intermittently 20 20
Adverse Event Without Identified Device or Use Problem 16 17
Moisture Damage 16 16
Output below Specifications 15 15
Failure to Sense 13 13
Intermittent Capture 12 13
Over-Sensing 9 9
Output above Specifications 8 8
Failure to Shut Off 8 8
Premature Discharge of Battery 8 8
Failure to Calibrate 6 6
Sensing Intermittently 6 6
Failure of Device to Self-Test 6 6
Inadequate User Interface 5 5
Key or Button Unresponsive/not Working 4 4
Blocked Connection 4 4
Circuit Failure 4 4
Operating System Becomes Nonfunctional 4 4
Noise, Audible 3 3
Contamination /Decontamination Problem 3 3
Impedance Problem 3 3
Device Difficult to Program or Calibrate 3 3
Insufficient Information 3 3
Device Contamination with Chemical or Other Material 3 3
Application Program Freezes, Becomes Nonfunctional 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3560 3561
Cardiac Arrest 39 39
Ventricular Fibrillation 30 30
Asystole 30 30
Arrhythmia 23 24
Tachycardia 16 16
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
Erythema 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 4
Blister 2 2
Skin Inflammation/ Irritation 2 2
Multiple Organ Failure 2 2
Pericardial Effusion 2 3
Syncope/Fainting 2 2
Unspecified Heart Problem 2 2
Non specific EKG/ECG Changes 2 2
Aspiration/Inhalation 2 2
Abrasion 2 2
Diaphoresis 2 2
Discomfort 2 2
Low Oxygen Saturation 2 2
Dizziness 2 2
Pneumonia 2 2
Pulmonary Edema 1 1
Sepsis 1 1
Septic Shock 1 1
Shock 1 1
Skin Discoloration 1 1
Cardiac Tamponade 1 1
Stenosis 1 1
Respiratory Failure 1 1
Sudden Cardiac Death 1 1
Cardiac Perforation 1 1
Pallor 1 1
Angina 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
Dyspnea 1 1
Hemorrhage/Bleeding 1 1
Hypoxia 1 1
Unspecified Infection 1 1
Muscle Weakness 1 1
Nausea 1 1
Device Overstimulation of Tissue 1 1

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