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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dorsal root ganglion stimulator for pain relief
Definition Stimulation of the dorsal root ganglion for the treatment of chronic, intractable pain of the lower limbs.
Product CodePMP
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 0 0 0 0 0 0 0 0 4 9

Device Problems
No Known Device Problem 537
Impedance issue 58
Fracture 31
High impedance 10
Low impedance 7
Device or device component damaged by another device 6
Difficult to insert 4
Disconnection 3
Device operates differently than expected 3
Difficult to remove 3
Device inoperable 2
No device output 2
User used incorrect product for intended use 1
Break 1
Material frayed 1
Wireless communication issue 1
Material separation 1
Device stops intermittently 1
Total Device Problems 672

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