Vercise Genus Or Vercise Gevia Full System Configuration - Boston Scientific ImageReady MRI Mode D'emploi

ImageReady™ MRI Guidelines for Boston Scientific Deep Brain Stimulation Systems

Vercise Genus or Vercise Gevia Full System Configuration

Table 6. Vercise Genus or Vercise Gevia Full System Configuration
Full System Configuration(s)
System Programming
5 An MRI can also be performed safely if, instead of the Burr Hole Cover, a mini plate similar to a Stryker 12 mm titanium mini plate with Stryker titanium
screws is used to secure the DBS Leads to the skull. Boston Scientific has not evaluated the effect of other implanted devices in combination with or in
proximity to the Boston Scientific Systems described in this manual. Boston Scientific does not recommend an MRI scan if other implanted devices are
present.
6 An impedance check is automatically performed for Stimulator‑Lead integrity when MRI Mode is enabled on the device. See the "MRI Mode for Full
Systems" section of this manual for more information on MRI Mode.
7 Stimulation is automatically turned OFF when MRI Mode is enabled. See the "MRI Mode for Full Systems" section of this manual for more information on
MRI Mode including instructions for enabling MRI Mode.
ImageReady™ MRI Guidelines for Boston Scientific Deep Brain Stimulation Systems
92328636-03 8 of 957
• A fully implanted DBS System is comprised of Leads, Lead Extensions, Stimulator and a Burr
Hole Cover or alternative method of securing Leads
components).
• The Vercise Genus Stimulator must be implanted under the skin in a location near the clavicle
(pectoral region) or in the abdomen on the same side of the body as the implanted Lead(s) and
Lead Extension(s).
• The Vercise Gevia Stimulator must be implanted under the skin in a location near the clavicle
(pectoral region) on the same side of the body as the implanted Lead(s) and Lead Extension(s).
○ The Vercise Gevia Stimulator should not be implanted in the abdomen and is not scan eligible
when implanted in the abdomen.
• Patients with up to two Leads implanted are scan eligible.
• In a bilateral implant where two Leads and Lead Extensions are connected to a single Stimulator,
both Lead‑Extensions must be routed on the same side of the body as the Stimulator.
• Unused Stimulator Ports require a Port Plug to be inserted in order to be scan eligible.
• Unused Lead Extension Ports when using the 2x8 Contact Lead Extension, DB‑3128, require a
Port Plug to be inserted to be scan eligible.
○ The 8 Contact Lead Extension, NM‑3138‑55, must have a Lead inserted to be scan eligible.
These Lead Extensions are not eligible to be scanned when a Port Plug is inserted.
Note: To confirm the presence of a Port Plug in a Stimulator or 2x8 Contact Lead Extension,
DB‑3128, check the patient's record or confirm with the implanting physician.
• Lead Extensions must be connected directly to the Stimulator. Adapters should not be used.
• When the Vercise Gevia Stimulator is implanted, only system configurations using DB‑2201 or
DB‑2202 Lead(s) with NM‑3138‑55 Lead Extension(s) are scan eligible.
• If multiple Stimulators are implanted, the patient is not scan eligible.
• No evidence can be found of fractured Leads or compromised Stimulator‑Lead integrity.
• MRI Mode must be enabled on the device prior to performing scan.
• Rechargeable Stimulators must be fully charged prior to the scan.
(see Table 4 and Table 5 for scan eligible
5
7
6