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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
2019 139 139
2020 189 190
2021 636 638
2022 226 226
2023 235 236
2024 1078 1079
2025 1201 1201

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 1687 1688
Computer Operating System Problem 1111 1112
Communication or Transmission Problem 957 959
Display or Visual Feedback Problem 911 912
Output Problem 276 276
Data Problem 201 203
Device Difficult to Program or Calibrate 133 135
Failure to Interrogate 126 127
Capturing Problem 115 115
Pacing Problem 90 90
Application Program Problem 84 84
Device Sensing Problem 83 83
Inadequate User Interface 64 64
Wireless Communication Problem 29 29
Problem with Software Installation 26 26
Device Displays Incorrect Message 25 25
Failure to Capture 21 21
Power Problem 19 19
Signal Artifact/Noise 17 17
Impedance Problem 14 14
Inappropriate/Inadequate Shock/Stimulation 14 15
Over-Sensing 12 12
Unexpected Shutdown 11 11
Mechanical Problem 6 6
Under-Sensing 6 6
Loose or Intermittent Connection 6 6
High impedance 5 5
Unable to Obtain Readings 3 5
Connection Problem 3 3
Material Integrity Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Battery Problem 2 2
Failure to Power Up 2 2
Application Program Version or Upgrade Problem 2 2
Appropriate Term/Code Not Available 2 3
Reset Problem 2 2
High Capture Threshold 2 2
Therapeutic or Diagnostic Output Failure 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Failure to Sense 1 1
Break 1 1
Low impedance 1 1
Human-Device Interface Problem 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3418 3421
No Known Impact Or Consequence To Patient 170 170
No Consequences Or Impact To Patient 75 75
Asystole 27 28
No Patient Involvement 14 14
Bradycardia 10 10
Arrhythmia 9 9
Cardiac Arrest 9 9
Tachycardia 9 9
Shock from Patient Lead(s) 6 7
Low Blood Pressure/ Hypotension 5 6
Heart Block 4 4
Dizziness 3 3
Insufficient Information 3 3
Presyncope 2 2
Atrial Fibrillation 2 2
Discomfort 2 2
Shock 2 2
Undesired Nerve Stimulation 2 2
Loss of consciousness 2 2
Non specific EKG/ECG Changes 1 1
Syncope/Fainting 1 1
Pneumothorax 1 1
Pericardial Effusion 1 1
Cardiac Tamponade 1 1
Pleural Effusion 1 1
Fall 1 1
Pain 1 1

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