Definition: Bilateral Stimulation Of The Internal Globus Pallidus (GPi) Or The Subthalamic Nucleus (STN) Using Medtronic Activa Parkinson's Control Therapy Is Indicated For Adjunctive Therapy In Reducing Some Of The Symptoms Of Advanced, Levodopa-responsive Park
| Device Type ID | 3850 |
| Device Name | Stimulator, Electrical, Implanted, For Parkinsonian Symptoms |
| 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 | NHL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3850 |
| Device | Stimulator, Electrical, Implanted, For Parkinsonian Symptoms |
| Product Code | NHL |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 71 |
High Impedance | 5 |
Migration Or Expulsion Of Device | 4 |
Unexpected Therapeutic Results | 3 |
Migration | 3 |
Battery Problem | 2 |
Device Issue | 2 |
Malposition Of Device | 1 |
Defective Device | 1 |
Failure To Fire | 1 |
Communication Or Transmission Problem | 1 |
Device Operates Differently Than Expected | 1 |
Premature Discharge Of Battery | 1 |
Use Of Device Problem | 1 |
No Apparent Adverse Event | 1 |
| Total Device Problems | 98 |