| Device Type ID | 3841 |
| Device Name | Stimulator, Brain, Implanted, For Behavior Modification |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurostimulation Devices Psychiatry Branch (NSDP) |
| Submission Type | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | MFR |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3841 |
| Device | Stimulator, Brain, Implanted, For Behavior Modification |
| Product Code | MFR |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 45 |
Device Operates Differently Than Expected | 18 |
High Impedance | 16 |
Break | 9 |
Low Battery | 7 |
Device Displays Incorrect Message | 7 |
Inappropriate Shock | 5 |
Battery Problem | 5 |
Charging Problem | 5 |
Low Impedance | 4 |
Migration Or Expulsion Of Device | 4 |
Malposition Of Device | 3 |
Failure To Deliver Energy | 3 |
Therapy Delivered To Incorrect Body Area | 2 |
Material Deformation | 2 |
Delayed Charge Time | 2 |
Communication Or Transmission Problem | 2 |
Pocket Stimulation | 2 |
Unstable | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Material Integrity Problem | 2 |
Intermittent Continuity | 2 |
Premature Discharge Of Battery | 1 |
Device Difficult To Program Or Calibrate | 1 |
Connection Problem | 1 |
Appropriate Term/Code Not Available | 1 |
Human-Device Interface Problem | 1 |
Positioning Problem | 1 |
Disconnection | 1 |
Noise, Audible | 1 |
Unintended Collision | 1 |
Electromagnetic Interference | 1 |
| Total Device Problems | 159 |