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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)
2015 2016 2017 2018 2019 2020
2 14 9 3 7 6

Device Problems
Adverse Event Without Identified Device or Use Problem 4029
Fracture 1514
High impedance 1293
Premature End-of-Life Indicator 590
Mechanical Problem 249
Corroded 240
Insufficient Information 240
Low impedance 187
Energy Output Problem 163
Computer Software Problem 158
Device Operates Differently Than Expected 143
Device Contamination with Body Fluid 125
Device Displays Incorrect Message 111
Communication or Transmission Problem 100
Fluid Leak 100
Failure to Interrogate 96
Energy Output To Patient Tissue Incorrect 88
Battery Problem 85
Incorrect, Inadequate or Imprecise Result or Readings 84
Cable 71
Device Contaminated during manufacture or shipping 69
Device Inoperable 67
Appropriate Term/Code Not Available 57
Detachment Of Device Component 56
Break 52
Detachment of Device or device Component 41
Lead 35
Failure to Charge 31
Generator 31
Failure to Power Up 30
Premature Discharge of Battery 27
Migration or Expulsion of Device 25
Battery 24
Low Battery 24
Programming Issue 24
Handpiece 23
Use of Incorrect Control Settings 19
No Display / Image 17
Application Interface Becomes Non-Functional Or Program Exits Abnormally 16
Loose or Intermittent Connection 15
Under-Sensing 14
Screen 14
Disconnection 12
Charging Problem 12
Protective Measures Problem 12
Connection Problem 11
Improper or Incorrect Procedure or Method 11
Therapy Delivered to Incorrect Body Area 11
Failure to Sense 11
Difficult to Insert 11
Defective Component 10
Computer Operating System Problem 10
Material Protrusion / Extrusion 10
Human-Device Interface Problem 9
Operating System Becomes Nonfunctional 9
Component Missing 9
Unexpected Therapeutic Results 9
Malposition of device 9
Difficult to Interrogate 9
Crack 8
Port 8
Failure of Device to Self-Test 7
Output Problem 7
Positioning Problem 6
Improper Device Output 6
Extrusion 6
Unable to Obtain Readings 6
Inappropriate Shock 6
Device Stops Intermittently 6
Intermittent Continuity 6
Image Display Error / Artifact 5
Adapter (Adaptor) 5
Keypad 5
Device Sensing Problem 5
Difficult to Remove 4
Over-Sensing 4
Display 4
Degraded 4
Operating System Version or Upgrade Problem 4
Moisture or Humidity Problem 3
Impedance Problem 3
Manufacturing, Packaging or Shipping Problem 3
Therapeutic or Diagnostic Output Failure 3
Material Frayed 3
Wire 3
Screw 3
Cover 3
Component Falling 3
Loss of Power 3
No Device Output 3
Defective Device 3
Failure to Advance 3
High Test Results 3
Device Dislodged or Dislocated 2
Electromagnetic Compatibility Problem 2
Device Slipped 2
False Alarm 2
Latch 2
Housing 2
Connector 2
Total Device Problems 10720

Recalls
Manufacturer Recall Class Date Posted
1 Cyberonics, Inc II Feb-08-2018
2 Cyberonics, Inc II Aug-11-2017
3 Cyberonics, Inc II Jan-15-2016
4 Cyberonics, Inc II Jan-13-2016
5 Cyberonics, Inc II Nov-17-2015
6 Cyberonics, Inc II Apr-27-2015
7 LivaNova USA Inc II Mar-24-2020
8 LivaNova USA Inc II Feb-10-2020
9 LivaNova USA Inc II Jan-27-2020
10 LivaNova USA Inc I Dec-20-2019
11 LivaNova USA Inc II Dec-10-2019
12 LivaNova USA Inc II Nov-07-2019
13 LivaNova USA Inc II Jul-28-2018

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