Vercise Deep Brain Stimulation (DBS) System

• • Ongoing Z-2558-2025 FDA Class II ·initiated 8 Jul 2025

  Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.

• • Ongoing Z-2340-2025 FDA Class II ·initiated 8 Jul 2025

  Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.

• • Ongoing Z-1890-2024 FDA Class II ·initiated 18 Apr 2024

  Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.

• • Terminated Z-2125-2020 FDA Class II ·initiated 24 Apr 2019

  The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.

Full name

Vercise Deep Brain Stimulation (DBS) System and Vercise Gevia Deep Brain Stimulation (DBS) System

Trade name

Vercise Deep Brain Stimulation (Dbs)System

Generic name

Stimulator, electrical, implanted, for parkinsonian symptoms

FDA applicant

Boston Scientific Corp

PMA number

P150031 ↗

FDA product code

NHL

Device class

Class III

Advisory committee

Neurology

FDA decision

APPR Approved

• OPAL HDx™ M004OPAL14010

  Class II

  GUDID on market

• Acuity™

  Class III

  CE/MDD

• WALLSTENT-Uni™

  Class IIb

  CE/MDD

• Multi-Point Thermal Sensor

  Class IIa

  CE/MDR

• Epic™

  Class IIb

  CE/MDD

• WallFlex™

  Class IIb

  CE/MDD

See all devices from Boston Scientific →

• What specific symptoms of Parkinson’s disease does the Vercise DBS System target, and how does it work to address them?

  The Vercise DBS System is designed to target motor symptoms associated with moderate to advanced levodopa-responsive Parkinson’s disease (PD) that are not adequately controlled by medication alone. It delivers bilateral electrical stimulation to the subthalamic nucleus (STN), a brain region involved in regulating movement. By modulating neural activity in the STN, the system helps manage tremors, rigidity, bradykinesia (slowness of movement), and other motor fluctuations commonly experienced by patients with PD.

• Is the Vercise DBS System reusable or single-use, and what does the surgical process involve?

  The Vercise DBS System is reusable and intended for implantation, meaning it is surgically placed under the skin and connected to leads targeting the STN. The system includes pulse generators and associated leads, which require professional implantation by trained neurosurgeons and neurologists. The procedure involves precise placement of electrodes in the brain, followed by connection to the implanted stimulator, which is then programmed to deliver targeted therapy.

• Can patients with this device undergo MRI scans, and if so, what conditions apply?

  Yes, certain models of the Vercise DBS System are MRI-conditional, allowing for full-body MRI access under specific conditions. However, compatibility depends on the exact model and settings, so it’s critical to verify with the manufacturer or clinical guidelines before scheduling an MRI. Always follow the device’s programming and safety instructions to avoid interference or damage.

• How is the Vercise DBS System regulated, and what does this mean for clinicians or facilities using it?

  The Vercise DBS System is classified as a Class III medical device under FDA regulations and has received Premarket Approval (PMA) under the designation P150031. This means it has undergone rigorous clinical evaluation to demonstrate safety and effectiveness for its intended use—bilateral STN stimulation in Parkinson’s disease patients unresponsive to medication alone. Clinicians and facilities must adhere to FDA guidelines, including proper training, surgical protocols, and programming instructions provided by the manufacturer.