Device And Product Description; Contraindications; Safety Information; Instructions For The Patient - Boston Scientific Precision Montage MRI Informacion Para Medicos

Device and Product Description

Device and Product Description
The Precision Montage™ MRI Spinal Cord Stimulator System consists of an implantable
pulse generator (IPG), temporary percutaneous Leads, permanent MRI percutaneous Leads
Surgical Paddle Leads, Lead Extensions, OR Cables, Trial Stimulator, Remote Control,
Clinician Programmer, and Programming Wand, each packaged as a separate kit. Single use
accessories and disposable tools are also included in these kits.
Features of the Precision Montage MRI System include:
• Stimulation electrode field navigation
• Sixteen independent current-controlled electrodes
• Four programmable stimulation areas per program; sixteen possible programs
• Long-life operation
• High-range parameter capability
• Small size
• Two-foot programming range
• This product contains no detectable latex

Contraindications

Patients contraindicated for permanent Spinal Cord Stimulator (SCS) therapy are those who:
• are unable to operate the SCS system
• have failed trial stimulation by failing to receive effective pain relief
• are poor surgical risks
• are pregnant

Safety Information

WARNING: Unauthorized modification to the medical devices is prohibited. System integrity
could be compromised and harm or injury to the patient could occur if the medical devices are
subjected to unauthorized modification.

Instructions for the Patient

Warnings
Heat Due to Charging. Patients should not charge while sleeping. This may result in a burn.
While charging, the Charger may become warm. It should be handled with care. Failure to
use the Charger with either the Charging Belt or an adhesive patch, as shown, may result
in a burn. If patients experience pain or discomfort, they should cease charging and contact
Boston Scientific.
Precision Montage™ MRI System Information for Prescribers
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