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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
2019 136 136
2020 188 189
2021 635 637
2022 217 217
2023 213 214
2024 1073 1073
2025 1194 1194
2026 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 1679 1680
Computer Operating System Problem 1083 1084
Communication or Transmission Problem 945 947
Display or Visual Feedback Problem 904 905
Output Problem 274 274
Data Problem 203 205
Device Difficult to Program or Calibrate 131 133
Failure to Interrogate 126 127
Capturing Problem 112 112
Pacing Problem 88 88
Application Program Problem 84 84
Device Sensing Problem 83 83
Inadequate User Interface 63 63
Wireless Communication Problem 30 30
Problem with Software Installation 26 26
Device Displays Incorrect Message 25 25
Failure to Capture 21 21
Power Problem 19 19
Signal Artifact/Noise 17 17
Impedance Problem 14 14
Over-Sensing 12 12
Inappropriate/Inadequate Shock/Stimulation 12 12
Unexpected Shutdown 10 10
Mechanical Problem 6 6
High impedance 5 5
Under-Sensing 5 5
Connection Problem 4 4
Loss of Data 4 4
Loose or Intermittent Connection 4 4
Protective Measures Problem 4 4
Use of Incorrect Control/Treatment Settings 3 3
Unable to Obtain Readings 3 5
Failure to Transmit Record 3 3
Failure to Sense 3 3
Failure to Power Up 2 2
Use of Device Problem 2 2
Application Program Version or Upgrade Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Nonstandard Device 2 2
Reset Problem 2 2
High Capture Threshold 2 2
Material Integrity Problem 2 2
Appropriate Term/Code Not Available 2 3
Application Program Freezes, Becomes Nonfunctional 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Inappropriate or Unexpected Reset 1 1
Missing Test Results 1 1
Patient Data Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3386 3389
No Known Impact Or Consequence To Patient 167 167
No Consequences Or Impact To Patient 74 74
Asystole 27 28
No Patient Involvement 14 14
Bradycardia 10 10
Arrhythmia 9 9
Cardiac Arrest 9 9
Tachycardia 9 9
Insufficient Information 6 6
Shock from Patient Lead(s) 5 5
Low Blood Pressure/ Hypotension 5 6
Unspecified Vascular Problem 4 4
Heart Block 4 4
Dizziness 3 3
Failure of Implant 2 2
Presyncope 2 2
Atrial Fibrillation 2 2
Discomfort 2 2
Undesired Nerve Stimulation 2 2
Shock 2 2
Loss of consciousness 2 2
Non specific EKG/ECG Changes 1 1
Syncope/Fainting 1 1
Pneumothorax 1 1
Pericardial Effusion 1 1
Cardiac Tamponade 1 1
Pleural Effusion 1 1
Fall 1 1
Pain 1 1

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