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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 681 681

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 782 782
Computer Operating System Problem 719 719
Display or Visual Feedback Problem 523 523
Communication or Transmission Problem 513 513
Output Problem 122 122
Capturing Problem 113 113
Data Problem 111 111
Device Difficult to Program or Calibrate 107 107
Failure to Interrogate 99 99
Pacing Problem 76 76
Device Sensing Problem 67 67
Inadequate User Interface 44 44
Failure to Capture 19 19
Power Problem 16 16
Application Program Problem 15 15
Signal Artifact/Noise 13 13
Over-Sensing 12 12
Impedance Problem 12 12
Unexpected Shutdown 10 10
Inappropriate/Inadequate Shock/Stimulation 9 9
Problem with Software Installation 8 8
Under-Sensing 6 6
Mechanical Problem 6 6
High impedance 5 5
Device Displays Incorrect Message 5 5
Loose or Intermittent Connection 4 4
Unable to Obtain Readings 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Failure to Power Up 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
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1851 1851
No Known Impact Or Consequence To Patient 170 170
No Consequences Or Impact To Patient 75 75
Asystole 22 22
No Patient Involvement 14 14
Cardiac Arrest 7 7
Arrhythmia 5 5
Shock from Patient Lead(s) 5 5
Bradycardia 4 4
Tachycardia 3 3
Low Blood Pressure/ Hypotension 3 3
Insufficient Information 3 3
Heart Block 2 2
Dizziness 2 2
Shock 2 2
Loss of consciousness 2 2
Cardiac Tamponade 1 1
Undesired Nerve Stimulation 1 1
Pleural Effusion 1 1
Pneumothorax 1 1
Atrial Fibrillation 1 1
Non specific EKG/ECG Changes 1 1
Fall 1 1
Pericardial Effusion 1 1
Syncope/Fainting 1 1

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