Risks And Potential Interactions - Boston Scientific Spectra WaveWriter Mode D'emploi

Risks and Potential Interactions

The Spectra WaveWriter SCS System with ImageReady MRI Technology has been shown through non-
clinical testing to minimize the potential interactions with MRI when the appropriate conditions described
in this manual are followed. Risks related to SCS implant geometries or locations outside the directions for
use have not been evaluated.
The known potential residual risks include:
• The Spectra WaveWriter SCS System IPG may move within the implant pocket or become warm,
which may cause patient discomfort.
• Induced electrical stimulation of the patient could cause an uncomfortable sensation.
Factors that increase these residual risks include, but are not limited to, the following:
• Lead lengths longer than 50 cm and/or use of extensions, adapters, or splitters may increase the
risk of stimulation or jolting sensations.
• Performing MRI scans above Normal Operating Mode exposure limits or in scanners with higher
maximum slew rate limits may increase the risk of stimulation or uncomfortable sensations or
implant pocket temperature rise.
• Any component of the Spectra WaveWriter SCS System (such as the implanted Leads, IPG, etc)
extending into the Transmit/Receive RF Head Coil or within 10cm of the Head Coil may increase
the risk of stimulation or jolting sensations.
ImageReady MRI Guidelines for Spectra WaveWriter Spinal Cord Stimulator System
Warnings, Limitations, and Risks
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