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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, indirect
Product CodeKRE
Regulation Number 870.3640
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 1 1
2016 7 7
2017 1 1
2018 6 6
2019 3 3
2020 4 4
2021 14 14
2022 2 2
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Data Problem 33 33
Communication or Transmission Problem 4 4
Output Problem 2 2
Appropriate Term/Code Not Available 2 2
Display Difficult to Read 1 1
Date/Time-Related Software Problem 1 1
Human-Device Interface Problem 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
No Patient Involvement 15 15
No Known Impact Or Consequence To Patient 9 9
Insufficient Information 2 2
Anxiety 1 1

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