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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
Product CodeDTC
Regulation Number 870.3630
Device Class 2

MDR Year MDR Reports MDR Events
2019 139 139
2020 189 189
2021 637 637
2022 228 228
2023 237 237
2024 832 832

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 840 840
Computer Operating System Problem 771 771
Communication or Transmission Problem 592 592
Display or Visual Feedback Problem 567 567
Output Problem 144 144
Data Problem 113 113
Capturing Problem 113 113
Device Difficult to Program or Calibrate 109 109
Failure to Interrogate 107 107
Pacing Problem 83 83
Device Sensing Problem 70 70
Inadequate User Interface 46 46
Application Program Problem 23 23
Failure to Capture 20 20
Power Problem 17 17
Impedance Problem 14 14
Signal Artifact/Noise 13 13
Over-Sensing 12 12
Unexpected Shutdown 10 10
Inappropriate/Inadequate Shock/Stimulation 10 10
Problem with Software Installation 8 8
Mechanical Problem 6 6
Under-Sensing 6 6
Device Displays Incorrect Message 5 5
High impedance 5 5
Loose or Intermittent Connection 4 4
Unable to Obtain Readings 3 3
Reset Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Application Program Version or Upgrade Problem 2 2
Connection Problem 2 2
Battery Problem 2 2
Appropriate Term/Code Not Available 2 2
Failure to Power Up 2 2
High Capture Threshold 2 2
Wireless Communication Problem 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Low impedance 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Sense 1 1
Corroded 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1995 1995
No Known Impact Or Consequence To Patient 170 170
No Consequences Or Impact To Patient 75 75
Asystole 24 24
No Patient Involvement 14 14
Cardiac Arrest 8 8
Arrhythmia 6 6
Shock from Patient Lead(s) 6 6
Bradycardia 5 5
Tachycardia 5 5
Low Blood Pressure/ Hypotension 4 4
Insufficient Information 3 3
Heart Block 2 2
Dizziness 2 2
Loss of consciousness 2 2
Undesired Nerve Stimulation 2 2
Shock 2 2
Cardiac Tamponade 1 1
Fall 1 1
Pleural Effusion 1 1
Syncope/Fainting 1 1
Non specific EKG/ECG Changes 1 1
Atrial Fibrillation 1 1
Pericardial Effusion 1 1
Pneumothorax 1 1

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