Definition: For The Treatment Of Epilepsy.
| Device Type ID | 3864 |
| Device Name | Implanted Brain Stimulator For Epilepsy |
| Physical State | The Main Components Of The Device Include Implanted Leads (depth And Cortical), Implanted Neurostimulator, And External Programmers. |
| Technical Method | Uses An Implanted Neurostimulator To Sense ECoG Activity And Provide Stimulation To Depth And/or Cortical Leads. |
| Target Area | Seizure Focii In The Brain |
| 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 | PFN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3864 |
| Device | Implanted Brain Stimulator For Epilepsy |
| Product Code | PFN |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 126 |
High Impedance | 19 |
Break | 17 |
Signal Artifact | 15 |
Fracture | 5 |
Device Remains Activated | 4 |
Failure To Interrogate | 2 |
Battery Problem | 2 |
Insufficient Information | 2 |
Missing Value Reason | 1 |
Mechanical Problem | 1 |
Material Fragmentation | 1 |
Off-Label Use | 1 |
Material Separation | 1 |
Under-Sensing | 1 |
Unexpected Therapeutic Results | 1 |
Low Impedance | 1 |
| Total Device Problems | 200 |