Mr Conditional System Description; Dbs Implant System Conditions - Boston Scientific ImageReady MRI Mode D'emploi

MR Conditional System Description

MR Conditional System Description
A Full Body MR Conditional scan may be safely performed when implanted with the Boston Scientific DBS
components described in Table 1 and exposed to the MRI environment under specific conditions defined in
this manual.
Warning: Scanning under different conditions may result in severe patient injury or device malfunction.

DBS Implant System Conditions

The Full Body MR guidelines apply to the booted lead system that meets the following conditions:
• Patients implanted with a MR conditional system composed of the components listed in Table 1.
• Leads are capped with a lead boot on the proximal end and excess lead is coiled and fully-
implanted under the scalp on the skull.
• No evidence of fractured leads.
• No lead extensions are present.
• No stimulator is present.
Caution: The system has only been evaluated with a lead boot. Failure to boot the lead could increase the
chance of the risks described in the Safety Information Section of this manual under Potential Interactions
with MRI Environment.
Table 1 lists the model numbers of the Boston Scientific DBS System components that are eligible for a Full
Body MR Conditional scan.
Table 1. Boston Scientific DBS System components eligible for Full Body Conditional MR scan
Component
30 cm Lead
45 cm Lead
Vercise™ Cartesia™ 30 cm 8 Contact DBS Directional Lead
Vercise Cartesia 45 cm 8 Contact DBS Directional Lead
SureTek™ Burr Hole Cover
Lead Boot
Silicone Suture Sleeves
ImageReady™ MRI Guidelines for Boston Scientific Deep Brain Stimulation Systems
91098813-02 Rev C 2 of 277
Model Number (s)
DB-2201-30-AC
DB-2201-30-DC
DB-2201-45-BC
DB-2201-45-DC
DB-2202-30
DB-2202-45
Provided in kits DB-4600-C and DB-4605-C
Provided in the Vercise Physician Spares Kit
DB-2500-C and with DBS leads (see above)
Provided in Vercise Physician Spares Kit
DB-2500-C and with DBS leads (see above)