Boston Scientific Precision Manual Del Usuario página 6

Precision™ Spinal Cord Stimulator System 1.5 Tesla MRI Guidelines
Risks Associated with MRI
Examination
Exposing a patient with an implanted
neurostimulation system or component to
MRI may potentially injure the patient or
damage the Precision™ SCS System. The
known potential risks are as follows:
• Induced currents associated with the MRI
examination in a patient with the Precision
SCS System or any of its components
may cause heating, especially at the lead
electrode site, resulting in tissue damage.
Induced electrical currents may also
stimulate or shock the patient.
• Factors that increase the risks of patient
injury include, but are not limited to, the
following:
◦ Performing MRI scans outside Normal
Operating Mode
◦ The use of a transmit/receive RF head
coil that extends over any component
of the Precision SCS System (i.e. the
implanted leads, IPG, etc).
• Exposure to gradients exceeding a
dB/dt limit of 20 Tesla per second may
result in overstimulation, shocking, or
damage to the IPG.
• MRI may permanently damage the
neurostimulator, requiring device
explantation or replacement.
• MRI may affect the operation of the
Precision SCS System. The MRI may
also reset the parameters to power-on-
reset settings, requiring reprogramming
with the Precision SCS System Clinician's
Programmer.
Precision™ Spinal Cord Stimulator System 1.5 Tesla MRI Guidelines
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• The Precision IPG may move within the
implant pocket which may cause patient
discomfort or a recent IPG pocket incision
to open.
• SCS implant geometries or locations
outside the IFU have not been evaluated.
• Longer Lead lengths and use of
extensions may increase the risk of
overstimulation, shocking, or damage to
the IPG.
MRI PROCEDURE USING
A TRANSMIT/RECEIVE RF
HEAD COIL
If all of the instructions stated in this
document are followed, MRI examinations of
the head using a transmit/receive RF head
coil in a 1.5-Tesla horizontal bore MRI system
may be safely performed.
Supervision
Patient interaction during MRI – The patient
should be in a psychological condition and
mental state where the patient is able to
provide immediate feedback of any problems
during the examination.
Monitor the patient during the MRI
examination. Verify that the patient is
feeling normal and is responsive during and
between each individual scan sequence
of the MRI examination. Discontinue the
MRI immediately if the patient becomes
unresponsive to questions or experiences
any heating, pain, shocking sensations/
uncomfortable stimulation, or unusual
sensations.