Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA product code NHL · Class III (high risk) · Neurology
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 Parkinsons disease that are not adequately controlled with medication.
0510(k) clearances
1PMA approvals
4recalls
Implantimplanted device
PMA approvals
- P150031 Vercise Deep Brain Stimulation (Dbs)System · Boston Scientific Corp · 12/08/2017
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2558-2025 Class II | Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number:…Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted… | Boston Scientific Neuromodulation Corporation | 07/08/2025Open, Classified |
| Z-2340-2025 Class II | Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0.…Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of… | Boston Scientific Neuromodulation Corporation | 07/08/2025Open, Classified |
| Z-1890-2024 Class II | Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT…Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during… | Boston Scientific Neuromodulation Corporation | 04/18/2024Open, Classified |
| Z-2125-2020 Class II | Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage:…The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions… | Boston Scientific Neuromodulation Corporation | 04/24/2019Terminated |