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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 384 384

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 665 665
Computer Operating System Problem 601 601
Display or Visual Feedback Problem 457 457
Communication or Transmission Problem 416 416
Capturing Problem 110 110
Device Difficult to Program or Calibrate 101 101
Data Problem 100 100
Failure to Interrogate 94 94
Output Problem 87 87
Pacing Problem 70 70
Device Sensing Problem 64 64
Inadequate User Interface 43 43
Failure to Capture 19 19
Power Problem 16 16
Signal Artifact/Noise 13 13
Over-Sensing 12 12
Impedance Problem 12 12
Application Program Problem 10 10
Unexpected Shutdown 10 10
Inappropriate/Inadequate Shock/Stimulation 7 7
Problem with Software Installation 7 7
Under-Sensing 5 5
Mechanical Problem 5 5
High impedance 5 5
Loose or Intermittent Connection 4 4
Unable to Obtain Readings 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Device Displays Incorrect Message 2 2
Battery Problem 2 2
Reset Problem 2 2
Connection Problem 2 2
Appropriate Term/Code Not Available 2 2
Wireless Communication Problem 2 2
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
High Capture Threshold 1 1
Therapeutic or Diagnostic Output Failure 1 1
Low impedance 1 1
Application Program Version or Upgrade Problem 1 1
Failure to Sense 1 1
Failure to Power Up 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1560 1560
No Known Impact Or Consequence To Patient 170 170
No Consequences Or Impact To Patient 75 75
Asystole 19 19
No Patient Involvement 14 14
Cardiac Arrest 7 7
Arrhythmia 5 5
Bradycardia 4 4
Shock from Patient Lead(s) 4 4
Tachycardia 3 3
Insufficient Information 3 3
Loss of consciousness 2 2
Heart Block 2 2
Dizziness 2 2
Shock 2 2
Low Blood Pressure/ Hypotension 2 2
Undesired Nerve Stimulation 1 1
Pleural Effusion 1 1
Atrial Fibrillation 1 1
Non specific EKG/ECG Changes 1 1
Fall 1 1
Cardiac Tamponade 1 1
Pericardial Effusion 1 1
Syncope/Fainting 1 1

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