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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device programmer, pacemaker
Regulation Description Pacemaker programmers.
Product CodeKRG
Regulation Number 870.3700
Device Class 3

MDR Year MDR Reports MDR Events
2020 1689 1689
2021 1700 1700
2022 1359 1359
2023 1070 1070
2024 1548 1548
2025 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Device Difficult to Program or Calibrate 1745 1745
No Display/Image 1649 1649
Output Problem 1089 1089
Display or Visual Feedback Problem 921 921
Computer Operating System Problem 661 661
Failure to Calibrate 506 506
Unexpected Shutdown 469 469
Computer Software Problem 460 460
Failure to Power Up 287 287
Mechanical Problem 264 264
Overheating of Device 260 260
Electrical /Electronic Property Problem 253 253
Problem with Software Installation 204 204
Use of Device Problem 202 202
Communication or Transmission Problem 202 202
Power Problem 170 170
Material Integrity Problem 154 154
Connection Problem 145 145
Failure to Interrogate 141 141
Application Program Freezes, Becomes Nonfunctional 134 134
Data Problem 128 128
Break 114 114
Noise, Audible 109 109
Battery Problem 76 76
Application Program Problem 72 72
Calibration Problem 66 66
Corroded 61 61
Operating System Becomes Nonfunctional 61 61
Device Sensing Problem 55 55
Loose or Intermittent Connection 45 45
Crack 44 44
Interrogation Problem 43 43
Inadequate User Interface 43 43
Impedance Problem 41 41
Electrical Shorting 33 33
Wireless Communication Problem 31 31
Incorrect, Inadequate or Imprecise Result or Readings 28 28
Signal Artifact/Noise 26 26
Insufficient Information 23 23
No Device Output 20 20
Device Emits Odor 17 17
Component Missing 17 17
Contamination 14 14
Failure to Shut Off 14 14
Moisture Damage 12 12
Adverse Event Without Identified Device or Use Problem 12 12
Over-Sensing 10 10
Defective Device 10 10
Intermittent Communication Failure 10 10
Patient Data Problem 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6025 6025
No Patient Involvement 698 698
No Consequences Or Impact To Patient 476 476
No Known Impact Or Consequence To Patient 237 237
Insufficient Information 57 57
No Information 39 39
Asystole 7 7
Unspecified Infection 6 6
Dizziness 6 6
Cardiac Arrest 6 6
No Code Available 5 5
Loss of consciousness 4 4
Syncope/Fainting 4 4
Shock from Patient Lead(s) 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Tachycardia 3 3
Bacterial Infection 3 3
Injury 3 3
Electric Shock 2 2
Discomfort 2 2
Arrhythmia 2 2
Shock 2 2
Hearing Impairment 1 1
Convulsion/Seizure 1 1
Headache 1 1
Presyncope 1 1
Chest Pain 1 1
Abdominal Cramps 1 1
Burning Sensation 1 1
Blurred Vision 1 1
Ventricular Fibrillation 1 1
Dry Eye(s) 1 1
Anxiety 1 1
Heart Block 1 1
Low Blood Pressure/ Hypotension 1 1
Muscular Rigidity 1 1
Ventricular Tachycardia 1 1

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