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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
High impedance 456
No Known Device Problem 291
No Information 242
Device operates differently than expected 168
Fracture 126
Device displays error message 122
Failure to interrogate 107
Battery issue 96
Unknown (for use when the device problem is not known) 93
Device inoperable 77
Communication or transmission issue 68
Break 68
Low impedance 36
Failure to charge 32
Failure to power-up 32
Use of Incorrect Control Settings 30
Programming issue 30
Migration of device or device component 29
No display or display failure 26
Premature discharge of battery 24
Premature end-of-life indicator 20
Mechanical issue 20
Improper or incorrect procedure or method 18
Malfunction 16
Connection issue 16
Loose or intermittent connection 16
Application interface becomes non-functional or program exits abnormally 16
Disconnection 14
Charging issue 14
Unexpected therapeutic results 13
Low battery 12
Malposition of device 12
Human-Device Interface Issue 12
Material Protrusion 12
Detachment of device component 12
Corrosion 11
Explanted 11
Failure to sense 11
Defective component 10
Device Issue 10
Fluid leak 10
Operating system becomes non-functional 10
Difficult to interrogate 9
Extrusion 9
Component missing 9
Failure of device to self-test 8
Computer operating system issue 8
No device output 8
Leak 7
Image display error 7
Energy output to patient tissue incorrect 7
Undersensing 7
No code available 7
Positioning Issue 6
Device stops intermittently 6
Inappropriate shock 6
Electrical issue 6
Intermittent continuity 6
Loss of power 6
Unable to obtain readings 6
Replace 5
Difficult to insert 5
Poor quality image 5
Degraded 5
Crack 5
Computer software issue 5
Defective item 5
Device sensing issue 5
Self-activation or keying 4
Computer failure 4
Circuit Failure 4
Kinked 4
Operating system version or upgrade problem 4
Therapeutic or diagnostic output failure 4
Battery impedance issue 3
Moisture or humidity problem 3
Difficult to Program or Calibrate 3
Component falling 3
Material frayed 3
Slippage of device or device component 3
High test results 3
Failure to align 3
Failure to advance 3
Use of Device Issue 3
Impedance issue 3
Inappropriate or unexpected reset 3
Manufacturing or shipping issue associated with device 3
Dislodged or dislocated 3
Difficult or delayed activation 3
Patient-device incompatibility 3
Detachment of device or device component 3
Electrical shorting 2
Electromagnetic compatibility issue 2
Improper device output 2
Difficult to open or close 2
Vibration 2
Sticking 2
Size incorrect for patient 2
Device expiration issue 2
Failure to deliver energy 2
Total Device Problems 2710

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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