| Device Type ID | 3839 |
| Device Name | Stimulator, Autonomic Nerve, Implanted For Epilepsy |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurostimulation Devices Neurology Branch (NSDN) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LYJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3839 |
| Device | Stimulator, Autonomic Nerve, Implanted For Epilepsy |
| Product Code | LYJ |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2565 |
Fracture | 1042 |
High Impedance | 959 |
Premature End-of-Life Indicator | 418 |
Insufficient Information | 246 |
Mechanical Problem | 174 |
Corroded | 172 |
Device Operates Differently Than Expected | 146 |
Low Impedance | 125 |
Device Displays Incorrect Message | 112 |
Fluid Leak | 100 |
Failure To Interrogate | 91 |
Communication Or Transmission Problem | 88 |
Energy Output To Patient Tissue Incorrect | 88 |
Battery Problem | 85 |
Cable | 71 |
Device Inoperable | 68 |
Computer Software Problem | 58 |
Detachment Of Device Component | 56 |
Break | 55 |
Energy Output Problem | 52 |
Device Contamination With Body Fluid | 49 |
Appropriate Term/Code Not Available | 48 |
Lead | 37 |
Device Contaminated During Manufacture Or Shipping | 37 |
Generator | 31 |
Failure To Charge | 31 |
Failure To Power Up | 30 |
Migration Or Expulsion Of Device | 29 |
Programming Issue | 26 |
Low Battery | 25 |
Handpiece | 24 |
Battery | 24 |
Premature Discharge Of Battery | 21 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 21 |
Detachment Of Device Or Device Component | 19 |
Use Of Incorrect Control Settings | 19 |
Improper Or Incorrect Procedure Or Method | 17 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 16 |
Screen | 15 |
No Display / Image | 15 |
Loose Or Intermittent Connection | 15 |
Disconnection | 12 |
Under-Sensing | 12 |
Material Protrusion / Extrusion | 12 |
Unexpected Therapeutic Results | 12 |
Charging Problem | 12 |
Failure To Sense | 11 |
Connection Problem | 11 |
Difficult To Insert | 11 |
Computer Operating System Problem | 10 |
Operating System Becomes Nonfunctional | 10 |
Defective Component | 10 |
Difficult To Interrogate | 9 |
Human-Device Interface Problem | 9 |
Component Missing | 9 |
Protective Measures Problem | 9 |
Malposition Of Device | 9 |
Therapy Delivered To Incorrect Body Area | 8 |
Port | 8 |
Failure Of Device To Self-Test | 7 |
Positioning Problem | 7 |
Crack | 7 |
Unable To Obtain Readings | 6 |
Device Stops Intermittently | 6 |
Inappropriate Shock | 6 |
Improper Device Output | 6 |
Extrusion | 6 |
Intermittent Continuity | 6 |
Degraded | 5 |
Device Sensing Problem | 5 |
Keypad | 5 |
Adapter (Adaptor) | 5 |
Image Display Error / Artifact | 5 |
Operating System Version Or Upgrade Problem | 4 |
Display | 4 |
Difficult To Remove | 4 |
Failure To Advance | 3 |
Screw | 3 |
Therapeutic Or Diagnostic Output Failure | 3 |
Wire | 3 |
Material Frayed | 3 |
Inappropriate Or Unexpected Reset | 3 |
High Test Results | 3 |
No Device Output | 3 |
Device Slipped | 3 |
Defective Device | 3 |
Output Problem | 3 |
Component Falling | 3 |
Impedance Problem | 3 |
Manufacturing, Packaging Or Shipping Problem | 3 |
Moisture Or Humidity Problem | 3 |
Loss Of Power | 3 |
Cover | 3 |
Poor Quality Image | 2 |
Reset Problem | 2 |
Failure To Deliver Energy | 2 |
Hole In Material | 2 |
Kinked | 2 |
Connector | 2 |
| Total Device Problems | 7661 |
| 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 | Cyberonics, Inc | II | Dec-23-2014 |
| 8 | LivaNova USA Inc | II | Jul-28-2018 |