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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
2021 634 636
2022 216 216
2023 208 209
2024 1062 1062
2025 1194 1194
2026 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 1548 1549
Computer Operating System Problem 1011 1012
Communication or Transmission Problem 861 863
Display or Visual Feedback Problem 835 836
Output Problem 253 253
Data Problem 181 182
Failure to Interrogate 120 120
Capturing Problem 105 105
Device Difficult to Program or Calibrate 94 95
Application Program Problem 82 82
Pacing Problem 65 65
Device Sensing Problem 61 61
Inadequate User Interface 55 55
Wireless Communication Problem 28 28
Device Displays Incorrect Message 25 25
Problem with Software Installation 25 25
Power Problem 18 18
Signal Artifact/Noise 16 16
Failure to Capture 12 12
Inappropriate/Inadequate Shock/Stimulation 12 12
Over-Sensing 10 10
Impedance Problem 7 7
Mechanical Problem 6 6
Unexpected Shutdown 5 5
Loose or Intermittent Connection 4 4
Connection Problem 3 3
Under-Sensing 2 2
Application Program Version or Upgrade Problem 2 2
Failure to Power Up 2 2
Appropriate Device Problem Term/Code Not Available 2 3
High Capture Threshold 2 2
Material Integrity Problem 2 2
Break 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Reset Problem 1 1
Human-Device Interface Problem 1 1
Unable to Obtain Readings 1 2
Therapeutic or Diagnostic Output Failure 1 1
Low impedance 1 1
Corroded 1 1
Battery Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3272 3274
Asystole 27 28
Insufficient Information 11 11
Tachycardia 9 9
Arrhythmia 9 9
Bradycardia 8 8
Cardiac Arrest 6 6
Low Blood Pressure/ Hypotension 5 6
Shock from Patient Lead(s) 5 5
Heart Block 4 4
Unspecified Vascular Problem 4 4
Dizziness 3 3
Failure of Implant 2 2
Loss of consciousness 2 2
Presyncope 2 2
Undesired Nerve Stimulation 2 2
Shock 2 2
Discomfort 2 2
Pleural Effusion 1 1
Syncope/Fainting 1 1
Pericardial Effusion 1 1
Cardiac Tamponade 1 1
Fall 1 1
Pneumothorax 1 1
Atrial Fibrillation 1 1
Pain 1 1

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