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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 1024 1024

Device Problems MDRs with this Device Problem Events in those MDRs
Device Difficult to Program or Calibrate 2007 2007
No Display/Image 1820 1820
Output Problem 1132 1132
Computer Operating System Problem 768 768
Failure to Calibrate 660 660
Display or Visual Feedback Problem 643 643
Unexpected Shutdown 551 551
Computer Software Problem 524 524
Electrical /Electronic Property Problem 316 316
Failure to Power Up 312 312
Mechanical Problem 303 303
Overheating of Device 292 292
Use of Device Problem 248 248
Problem with Software Installation 227 227
Communication or Transmission Problem 224 224
Connection Problem 175 175
Power Problem 172 172
Material Integrity Problem 166 166
Failure to Interrogate 162 162
Data Problem 142 142
Break 129 129
Application Program Freezes, Becomes Nonfunctional 121 121
Noise, Audible 109 109
Calibration Problem 84 84
Inadequate User Interface 83 83
Battery Problem 81 81
Operating System Becomes Nonfunctional 81 81
Device Sensing Problem 63 63
Corroded 62 62
Crack 55 55
Application Program Problem 55 55
Interrogation Problem 54 54
Loose or Intermittent Connection 51 51
Impedance Problem 39 39
Electrical Shorting 39 39
Signal Artifact/Noise 37 37
Incorrect Measurement 25 25
Wireless Communication Problem 25 25
Insufficient Information 25 25
Device Emits Odor 22 22
No Device Output 20 20
Incorrect, Inadequate or Imprecise Result or Readings 20 20
Component Missing 20 20
Contamination 19 19
Adverse Event Without Identified Device or Use Problem 18 18
Failure to Shut Off 17 17
Defective Device 12 12
Under-Sensing 11 11
Failure to Sense 11 11
Capturing Problem 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5469 5469
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 55 55
Unspecified Infection 11 11
Cardiac Arrest 8 8
Dizziness 7 7
Asystole 6 6
No Code Available 5 5
Loss of consciousness 4 4
Syncope/Fainting 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Pocket Erosion 3 3
Shock from Patient Lead(s) 3 3
Injury 3 3
Shock 3 3
Arrhythmia 2 2
Electric Shock 2 2
Bacterial Infection 2 2
Discomfort 2 2
Tachycardia 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
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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