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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, percutaneous, long term, intraspinal
Product CodeLNY
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
1 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0

MDR Year MDR Reports MDR Events
2014 5 5
2015 2 2
2016 1 1
2017 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 2 2
Leak/Splash 1 1
Migration or Expulsion of Device 1 1
Occlusion Within Device 1 1
Difficult to Remove 1 1
Unknown (for use when the device problem is not known) 1 1
Split 1 1
Malposition of Device 1 1
Device Operates Differently Than Expected 1 1
Insufficient Information 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Surgical procedure, additional 2 2
No Code Available 2 2
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Extravasation 1 1
Failure of Implant 1 1
Pain 1 1
Surgical procedure 1 1

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