Products and Procedures

A stereotactic head frame is attached to the patient's skull under local anesthetic to keep the patient comfortable. The patient is then imaged with the frame on, and the target(s) are localized using targeting software. For lead placement, a nickel-sized (14 mm) burr hole is then made in the patient's skull, and a burr-hole ring is affixed to each opening.

Prior to lead placement, microelectrode recording (MER) may be used to provide an additional level of target verification. Stereotactic frame guidance and techniques are then used to place the lead to the targeted area.

With the patient awake, a test stimulation is performed to confirm good therapeutic benefit with minimal or no side effects. When settings are found during the test stimulation to provide the maximum symptom suppression available to the patient, the implantable neurostimulator that can most closely approximates those parameters can be identified. It's important to note that not all neurostimulators have identical capabilities. For example, some neurostimulators will accommodate two leads, while others will not.

External neurostimulator models 37022 and 3625 can be used to assess the suitability of a Medtronic deep brain stimulation neurostimulator. For information on these products, see the DBS Product Ordering Guide.

Once lead placement is confirmed, the lead is secured by closing the burr-hole cover or Stimloc^™ protective cap.

The targeted deep brain stimulation site varies by movement disorder:

For Parkinson's Disease and Dystonia^*

Electrical stimulation is delivered to structures involved in the control of movement within the subthalamic nucleus (STN) and globus pallidus (GPi).

For Essential Tremor

Electrical stimulation is delivered to targeted cells in the left or right ventral intermediate nucleus (VIM) of the thalamus.

The neurostimulator is placed in a pocket in the subclavicular area. The lead is then connected to the extension, which is tunneled under the scalp, the skin of the neck, and down to the pocket. For bilateral applications, these steps are repeated for the other side.

Placement of the neurostimulator may be done on an inpatient or outpatient basis, and may or may not be done at the same time as the lead placement. Patients typically receive general anesthesia during this procedure.

• A small incision is made in the subclavicular area to create a pocket and the neurostimulator is placed in the pocket
• The lead is then connected to the extension, which is tunneled under the scalp, the skin of the neck, and down to the pocket. For bilateral applications, these steps are repeated for the other side

A deep brain stimulation patient typically is discharged the day following the placement of the leads. If the neurostimulator hasn't been placed along with the leads, the neurostimulator is usually implanted on an outpatient basis. In this case, the patient is discharged the same day.

Two to 4 weeks after surgery, a patient can go in for the first office visit to have the neurostimulator turned on and programmed, as determined by the clinician.

The patient will typically return to his or her clinician frequently in the first few months following surgery to optimize stimulation and titrate medications. Patients then resume a normal schedule of visits with their managing physician to monitor the status of their disease and adjust stimulation as necessary.

Battery longevity is dependent on neurostimulator settings and usage. Replacement of the neurostimulator is typically done on an outpatient basis. No intracranial procedure is typically necessary.

If a physician is implanting an Activa^® PC or Activa SC to replace a previous- generation deep brain stimulator (Kinetra^® or Soletra^®), then the lead extension model 37085 must be implanted to accommodate the new connector block.