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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device analyzer, pacemaker generator function
Regulation Description Pacemaker generator function analyzer.
Product CodeDTC
Regulation Number 870.3630
Device Class 2

MDR Year MDR Reports MDR Events
2020 189 189
2021 637 637
2022 228 228
2023 237 237
2024 1080 1080
2025 513 513

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 1253 1253
Computer Operating System Problem 918 918
Display or Visual Feedback Problem 782 782
Communication or Transmission Problem 756 756
Output Problem 205 205
Data Problem 157 157
Failure to Interrogate 120 120
Device Difficult to Program or Calibrate 116 116
Capturing Problem 114 114
Pacing Problem 79 79
Device Sensing Problem 64 64
Application Program Problem 57 57
Inadequate User Interface 47 47
Problem with Software Installation 23 23
Device Displays Incorrect Message 19 19
Wireless Communication Problem 19 19
Power Problem 18 18
Failure to Capture 18 18
Signal Artifact/Noise 17 17
Over-Sensing 12 12
Impedance Problem 11 11
Inappropriate/Inadequate Shock/Stimulation 11 11
Unexpected Shutdown 10 10
Mechanical Problem 6 6
Loose or Intermittent Connection 4 4
Connection Problem 3 3
Application Program Version or Upgrade Problem 2 2
Reset Problem 2 2
Failure to Power Up 2 2
Under-Sensing 2 2
Unable to Obtain Readings 2 2
High Capture Threshold 2 2
Appropriate Term/Code Not Available 2 2
Low impedance 1 1
High impedance 1 1
Break 1 1
Corroded 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Battery Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2734 2734
No Consequences Or Impact To Patient 75 75
No Known Impact Or Consequence To Patient 41 41
Asystole 27 27
No Patient Involvement 9 9
Arrhythmia 8 8
Cardiac Arrest 7 7
Tachycardia 7 7
Shock from Patient Lead(s) 6 6
Bradycardia 5 5
Low Blood Pressure/ Hypotension 5 5
Insufficient Information 3 3
Heart Block 3 3
Dizziness 2 2
Presyncope 2 2
Shock 2 2
Undesired Nerve Stimulation 2 2
Loss of consciousness 2 2
Syncope/Fainting 1 1
Pneumothorax 1 1
Pericardial Effusion 1 1
Cardiac Tamponade 1 1
Pleural Effusion 1 1
Discomfort 1 1
Fall 1 1

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