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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implanted brain stimulator for epilepsy
Definition For the treatment of epilepsy.
Product CodePFN
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 0 0 0 0 0 3 22 13 8 0

Device Problems
No Known Device Problem 41
High impedance 3
No Information 2
Artifact 2
Break 2
Fracture 2
Battery issue 2
Mechanical issue 1
Device remains activated 1
Unexpected therapeutic results 1
Undersensing 1
Total Device Problems 58

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