Definition: The Device Is Indicated For Bilateral Stimulation Of The Anterior Limb Of The Internal Capsule, This Device Is Indicated As An Adjunct To Medications And As An Alternative To Anterior Capsulotomy For Treatment Of Chronic, Severe, Treatment-resistant
| Device Type ID | 3856 |
| Device Name | Deep Brain Stimulator For Obsessive Compulsive Disorder (ocd) |
| Physical State | Electrodes, Extension And IPG |
| Technical Method | Deep Brain Stimulation |
| Target Area | Anterior Limb Of The Internal Capsule In The Brain |
| 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 | OLM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 3856 |
| Device | Deep Brain Stimulator For Obsessive Compulsive Disorder (ocd) |
| Product Code | OLM |
| Device Problems | |
|---|---|
Break | 2 |
Device Operates Differently Than Expected | 2 |
Low Impedance | 1 |
High Impedance | 1 |
Shipping Damage Or Problem | 1 |
Appropriate Term/Code Not Available | 1 |
Impedance Problem | 1 |
Positioning Problem | 1 |
Peeled / Delaminated | 1 |
| Total Device Problems | 11 |