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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, autonomic nerve, implanted (depression)
Definition The device is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
Product CodeMUZ
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 2 10 13 6 12 4

Device Problems
No Known Device Problem 12
High impedance 11
No Information 5
Unexpected therapeutic results 3
Device inoperable 3
Battery issue 2
Bent 2
Device operates differently than expected 2
Device displays error message 2
Failure to interrogate 1
Failure to charge 1
Human-Device Interface Issue 1
Programming issue 1
Communication or transmission issue 1
Low impedance 1
Failure to Adhere or Bond 1
Difficult to interrogate 1
Crack 1
Implant, reprogramming of 1
Output issue 1
Electrical shorting 1
Failure of device to self-test 1
Use of Incorrect Control Settings 1
Failure to power-up 1
Operating system version or upgrade problem 1
Total Device Problems 58

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