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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
2018 22 22
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 853 853
Computer Operating System Problem 776 776
Communication or Transmission Problem 598 598
Display or Visual Feedback Problem 568 568
Output Problem 148 148
Capturing Problem 114 114
Data Problem 113 113
Device Difficult to Program or Calibrate 110 110
Failure to Interrogate 107 107
Pacing Problem 84 84
Device Sensing Problem 73 73
Inadequate User Interface 46 46
Application Program Problem 23 23
Failure to Capture 20 20
Power Problem 17 17
Impedance Problem 16 16
Signal Artifact/Noise 13 13
Over-Sensing 12 12
Inappropriate/Inadequate Shock/Stimulation 10 10
Unexpected Shutdown 10 10
Problem with Software Installation 8 8
Device Displays Incorrect Message 6 6
Mechanical Problem 6 6
Under-Sensing 6 6
High impedance 5 5
Loose or Intermittent Connection 4 4
Connection Problem 4 4
Appropriate Term/Code Not Available 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Unable to Obtain Readings 3 3
Reset Problem 2 2
Wireless Communication Problem 2 2
Application Program Version or Upgrade Problem 2 2
Failure to Power Up 2 2
High Capture Threshold 2 2
Battery Problem 2 2
Corroded 1 1
Low impedance 1 1
Program or Algorithm Execution Problem 1 1
Noise, Audible 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Sense 1 1
Image Display Error/Artifact 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1997 1997
No Known Impact Or Consequence To Patient 191 191
No Consequences Or Impact To Patient 76 76
Asystole 24 24
No Patient Involvement 15 15
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
Dizziness 2 2
Shock 2 2
Undesired Nerve Stimulation 2 2
Loss of consciousness 2 2
Heart Block 2 2
Non specific EKG/ECG Changes 1 1
Syncope/Fainting 1 1
Pneumothorax 1 1
Atrial Fibrillation 1 1
Pericardial Effusion 1 1
Cardiac Tamponade 1 1
Pleural Effusion 1 1
Fall 1 1

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