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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 2
SHENZHEN LIFETECH CARDIO MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SOLO PACE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1001 1001
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 1493 1493
Mechanical Problem 802 802
No Display/Image 741 741
Calibration Problem 505 505
Display or Visual Feedback Problem 499 499
Output Problem 383 383
Device Sensing Problem 276 276
Unexpected Shutdown 265 265
Failure to Power Up 265 265
Use of Device Problem 261 261
Break 258 258
No Device Output 250 250
Material Integrity Problem 161 161
Component Missing 142 142
Corroded 129 129
Battery Problem 117 117
Electrical /Electronic Property Problem 111 111
Failure to Capture 86 86
Contamination 83 83
Loose or Intermittent Connection 67 67
Crack 62 62
Capturing Problem 46 46
Power Problem 46 46
Pacing Intermittently 32 32
Insufficient Information 32 32
Under-Sensing 28 28
Moisture Damage 27 27
Failure to Sense 26 26
Pacing Problem 25 25
Adverse Event Without Identified Device or Use Problem 20 20
Intermittent Capture 19 19
Output below Specifications 17 17
Inadequate User Interface 16 16
Failure to Shut Off 14 14
Contamination /Decontamination Problem 13 13
Output above Specifications 13 13
Blocked Connection 11 11
Device Difficult to Program or Calibrate 9 9
Difficult to Insert 8 8
Operating System Becomes Nonfunctional 8 8
Over-Sensing 8 8
Sensing Intermittently 8 8
Failure to Calibrate 8 8
Failure of Device to Self-Test 7 7
Data Problem 6 6
Premature Discharge of Battery 6 6
No Pacing 6 6
Noise, Audible 5 5
Defective Device 5 5
Circuit Failure 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3621 3621
No Patient Involvement 1430 1430
No Known Impact Or Consequence To Patient 388 388
No Consequences Or Impact To Patient 98 98
Cardiac Arrest 58 58
Ventricular Fibrillation 37 37
Arrhythmia 36 36
Asystole 27 27
Tachycardia 23 23
Bradycardia 20 20
Heart Block 10 10
Loss of consciousness 10 10
Insufficient Information 7 7
Superficial (First Degree) Burn 5 5
Low Blood Pressure/ Hypotension 5 5
Ventricular Tachycardia 5 5
Non specific EKG/ECG Changes 4 4
R On T Phenomenon 4 4
No Code Available 4 4
No Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Erythema 3 3
Injury 3 3
Low Oxygen Saturation 2 2
Unspecified Heart Problem 2 2
Pneumonia 2 2
Cardiopulmonary Arrest 2 2
Discomfort 2 2
Blister 2 2
Pericardial Effusion 2 2
Burn, Thermal 2 2
Abrasion 2 2
Aspiration/Inhalation 2 2
Skin Inflammation/ Irritation 2 2
Dizziness 2 2
Diaphoresis 2 2
Death 2 2
Syncope/Fainting 2 2
Multiple Organ Failure 1 1
Complete Heart Block 1 1
Device Overstimulation of Tissue 1 1
Skin Discoloration 1 1
Cardiac Tamponade 1 1
Burn(s) 1 1
Pallor 1 1
Cardiac Perforation 1 1
Perforation 1 1
Chest Pain 1 1
Septic Shock 1 1
Memory Loss/Impairment 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Detek, Inc. II Jul-03-2019
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