• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
21 9 3 10 24 0 0 0 2 6

Device Problems
High impedance 424
No Information 240
No Known Device Problem 169
Device operates differently than expected 168
Device displays error message 122
Failure to interrogate 107
Battery issue 93
Unknown (for use when the device problem is not known) 93
Device inoperable 77
Break 68
Communication or transmission issue 61
Fracture 48
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
Low impedance 29
No display or display failure 25
Premature discharge of battery 19
Improper or incorrect procedure or method 18
Malfunction 16
Connection issue 16
Application interface becomes non-functional or program exits abnormally 16
Loose or intermittent connection 16
Disconnection 14
Charging issue 14
Unexpected therapeutic results 13
Malposition of device 12
Human-Device Interface Issue 12
Material Protrusion 12
Low battery 11
Failure to sense 11
Explanted 11
Device Issue 10
Defective component 10
Operating system becomes non-functional 10
Component missing 9
Extrusion 9
Difficult to interrogate 9
No device output 8
Detachment of device component 8
Failure of device to self-test 8
Computer operating system issue 8
Leak 7
Image display error 7
Loss of power 6
Unable to obtain readings 6
Intermittent continuity 6
Electrical issue 6
Inappropriate shock 6
Device stops intermittently 6
Positioning Issue 6
Device sensing issue 5
Defective item 5
Degraded 5
Crack 5
Replace 5
Difficult to insert 5
Poor quality image 5
Kinked 4
Self-activation or keying 4
Computer failure 4
Computer software issue 4
Circuit Failure 4
No code available 4
Therapeutic or diagnostic output failure 4
Operating system version or upgrade problem 4
Moisture or humidity problem 3
Component falling 3
Material frayed 3
Difficult to Program or Calibrate 3
Patient-device incompatibility 3
Detachment of device or device component 3
Dislodged or dislocated 3
Battery impedance issue 3
Impedance issue 3
Inappropriate or unexpected reset 3
Manufacturing or shipping issue associated with device 3
Use of Device Issue 3
Slippage of device or device component 3
Difficult or delayed activation 3
Failure to align 3
Failure to advance 3
High test results 3
Sticking 2
Vibration 2
Size incorrect for patient 2
Improper device output 2
Material twisted 2
Electrical shorting 2
Electromagnetic compatibility issue 2
Difficult to open or close 2
Program, failure to 2
Fluid leak 2
Hole in material 2
Nonstandard device or device component 2
Loose 2
Device expiration issue 2
Corrosion 2
Total Device Problems 2381

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

-
-