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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device magnet, test, pacemaker
Product CodeDTG
Regulation Number 870.3690
Device Class 1


Premarket Reviews
ManufacturerDecision
CYBERONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 2 2
2018 1 1
2019 2 2
2021 1 1
2023 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Accessory Incompatible 3 3
Packaging Problem 2 2
High Capture Threshold 1 1
Difficult to Insert 1 1
Mechanical Problem 1 1
Use of Device Problem 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Vascular Dissection 1 1

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