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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 for epilepsy
Product CodeLYJ
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
21 9 3 10 24 0 0 0 2 14 2

Device Problems
No Known Device Problem 546
High impedance 496
No Information 249
Fracture 205
Device operates differently than expected 168
Device displays error message 122
Failure to interrogate 107
Battery issue 95
Unknown (for use when the device problem is not known) 93
Device inoperable 77
Communication or transmission issue 75
Break 68
Low impedance 48
Premature end-of-life indicator 35
Failure to charge 32
Failure to power-up 32
Use of Incorrect Control Settings 30
Mechanical issue 30
Programming issue 30
Migration of device or device component 29
Fluid leak 28
No display or display failure 26
Premature discharge of battery 24
Corrosion 23
Improper or incorrect procedure or method 18
Low battery 17
Connection issue 16
Malfunction 16
Application interface becomes non-functional or program exits abnormally 16
Energy output to patient tissue incorrect 16
Loose or intermittent connection 16
Detachment of device component 15
Disconnection 14
Charging issue 14
Unexpected therapeutic results 13
Malposition of device 12
Human-Device Interface Issue 12
Material Protrusion 12
Failure to sense 11
Explanted 11
Defective component 10
Device Issue 10
Operating system becomes non-functional 10
Extrusion 9
Component missing 9
Difficult to interrogate 9
No device output 8
Computer software issue 8
Failure of device to self-test 8
Computer operating system issue 8
Undersensing 7
Leak 7
Image display error 7
No code available 7
Positioning Issue 6
Difficult to insert 6
Loss of power 6
Unable to obtain readings 6
Electrical issue 6
Intermittent continuity 6
Device stops intermittently 6
Inappropriate shock 6
Defective item 5
Device sensing issue 5
Degraded 5
Crack 5
Replace 5
Poor quality image 5
Kinked 4
Computer failure 4
Circuit Failure 4
Self-activation or keying 4
Operating system version or upgrade problem 4
Therapeutic or diagnostic output failure 4
Battery impedance issue 3
Moisture or humidity problem 3
Slippage of device or device component 3
High test results 3
Use of Device Issue 3
Detachment of device or device component 3
Dislodged or dislocated 3
Impedance issue 3
Inappropriate or unexpected reset 3
Manufacturing or shipping issue associated with device 3
Difficult or delayed activation 3
Failure to align 3
Failure to advance 3
Patient-device incompatibility 3
Component falling 3
Material frayed 3
Difficult to Program or Calibrate 3
Program, failure to 2
Hole in material 2
Nonstandard device or device component 2
Loose 2
Device expiration issue 2
Failure to deliver energy 2
Battery failure 2
Coiled 2
Bent 2
Total Device Problems 3185

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 2 0 1 2 2 0 0 1 2 2 0
Class III 0 1 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cyberonics, Inc II Jan-15-2016
2 Cyberonics, Inc II Jan-13-2016
3 Cyberonics, Inc II Nov-17-2015
4 Cyberonics, Inc II Apr-27-2015
5 Cyberonics, Inc II Dec-23-2014
6 Cyberonics, Inc II Nov-18-2011
7 Cyberonics, Inc II Oct-04-2011
8 Cyberonics, Inc II May-10-2010
9 Cyberonics, Inc II Jan-14-2010
10 Cyberonics, Inc II Nov-16-2009
11 Cyberonics, Inc III Apr-22-2009
12 Cyberonics, Inc III Jan-29-2008
13 Cyberonics, Inc II Nov-28-2007
14 Cyberonics, Inc II Jan-25-2007

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