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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)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
3 0 1 1 0 0 1 0 0 0

Device Problems
Explanted 35
Migration of device or device component 8
Unknown (for use when the device problem is not known) 7
Leak 5
Improper or incorrect procedure or method 5
Disconnection 4
Component(s), broken 4
Detachment of device component 3
Blockage within device or device component 2
Dislodged 2
Occlusion within device 2
Fracture 2
Replace 2
Resistance, loss of 1
Material fragmentation 1
Device remains implanted 1
Device, or device fragments remain in patient 1
Fluid leak 1
Break 1
Coiled 1
Implant, removal of 1
Split 1
Total Device Problems 90

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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