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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device generator, pulse, pacemaker, external programmable (for electrophysiological studies only)
Product CodeJOQ
Regulation Number 870.1750
Device Class 2

MDR Year MDR Reports MDR Events
2019 4 4
2020 2 2
2021 2 2
2022 4 4
2023 10 10
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 6 6
Pacing Problem 4 4
No Display/Image 2 2
Mechanical Problem 2 2
Defective Device 2 2
Failure to Power Up 2 2
Device Displays Incorrect Message 2 2
Unexpected Shutdown 1 1
Output Problem 1 1
Smoking 1 1
Therapeutic or Diagnostic Output Failure 1 1
Computer Operating System Problem 1 1
Protective Measures Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
No Consequences Or Impact To Patient 4 4
No Known Impact Or Consequence To Patient 1 1
Ventricular Fibrillation 1 1
No Patient Involvement 1 1

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