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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2019 1174 1174
2020 1689 1689
2021 1700 1700
2022 1359 1359
2023 1070 1070
2024 1461 1461

Device Problems MDRs with this Device Problem Events in those MDRs
Device Difficult to Program or Calibrate 2015 2015
No Display/Image 1858 1858
Output Problem 1143 1143
Display or Visual Feedback Problem 912 912
Computer Operating System Problem 795 795
Failure to Calibrate 661 661
Unexpected Shutdown 571 571
Computer Software Problem 539 539
Electrical /Electronic Property Problem 319 319
Failure to Power Up 317 317
Overheating of Device 305 305
Mechanical Problem 304 304
Use of Device Problem 252 252
Communication or Transmission Problem 237 237
Problem with Software Installation 234 234
Connection Problem 183 183
Power Problem 182 182
Material Integrity Problem 170 170
Failure to Interrogate 165 165
Data Problem 157 157
Application Program Freezes, Becomes Nonfunctional 137 137
Break 132 132
Noise, Audible 122 122
Operating System Becomes Nonfunctional 84 84
Calibration Problem 84 84
Battery Problem 83 83
Inadequate User Interface 83 83
Application Program Problem 71 71
Device Sensing Problem 64 64
Corroded 64 64
Crack 56 56
Interrogation Problem 54 54
Loose or Intermittent Connection 52 52
Impedance Problem 42 42
Electrical Shorting 40 40
Signal Artifact/Noise 37 37
Wireless Communication Problem 32 32
Incorrect, Inadequate or Imprecise Result or Readings 26 26
Insufficient Information 25 25
Incorrect Measurement 25 25
No Device Output 22 22
Device Emits Odor 22 22
Adverse Event Without Identified Device or Use Problem 21 21
Component Missing 20 20
Contamination 19 19
Failure to Shut Off 17 17
Defective Device 12 12
Moisture Damage 12 12
Erratic or Intermittent Display 11 11
Failure to Sense 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5897 5897
No Patient Involvement 1258 1258
No Known Impact Or Consequence To Patient 803 803
No Consequences Or Impact To Patient 485 485
No Information 65 65
Insufficient Information 58 58
Unspecified Infection 12 12
Dizziness 8 8
Cardiac Arrest 8 8
Asystole 6 6
No Code Available 5 5
Syncope/Fainting 4 4
Loss of consciousness 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Pocket Erosion 3 3
Shock from Patient Lead(s) 3 3
Bacterial Infection 3 3
Injury 3 3
Tachycardia 3 3
Shock 3 3
Arrhythmia 2 2
Electric Shock 2 2
Discomfort 2 2
Low Blood Pressure/ Hypotension 1 1
Heart Block 1 1
Headache 1 1
Convulsion/Seizure 1 1
Blurred Vision 1 1
Endocarditis 1 1
Anxiety 1 1
Sudden Cardiac Death 1 2
Swelling 1 1
Muscular Rigidity 1 1
Chest Pain 1 1
Burning Sensation 1 1
Ventricular Fibrillation 1 1
Abdominal Cramps 1 1
Dry Eye(s) 1 1
Presyncope 1 1
Infection, Indirect 1 1
Ventricular Tachycardia 1 1
Sepsis 1 1
Failure of Implant 1 1
Convulsion, Clonic 1 1
Death 1 1
Hearing Impairment 1 1

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