Mri Procedure Using A Transmit/Receive Rf Head Coil - Boston Scientific Precision SC-1110 Serie Manual De Uso

Precision™ System Clinician Manual
• Physicians should not prescribe
MRI for patients undergoing trial
neurostimulation and/or having
systems that are not fully implanted.
• Do not remove the IPG and leave the
lead system implanted as this can
result in higher than expected lead
heating. Excessive heating can cause
tissue damage.
• Allow at least four weeks time from the
date of Precision System implantation
to the time of the MRI examination to
allow fibrous encapsulation of the IPG.
• If the IPG is implanted in the
subclavicular area or it has been less
than 4 weeks from IPG implantation
or revision, it is recommended that
restrictive bandaging be applied
over the IPG to prevent significant
movement or torque of the IPG by
forces that may be created by the
static magnetic field of the MRI system.
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 System. The known
potential risks are as follows:
• Induced currents associated with
the MRI examination in a patient
with the Precision 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.
Clinician Manual
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• Factors that increase the risks of
heating and patient injury include, but
are not limited to, the following:
• SAR levels that exceed the
recommended level of 1.5W/kg
• The use of a transmit/receive
RF head coil that extends over
any component of the Precision
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 System. The MRI
may also reset the parameters to
power-on-reset settings, requiring
reprogramming with the Precision
System Clinician's Programmer.
• The Precision IPG may move within
the implant pocket which may cause
patient discomfort or a recent IPG
pocket incision to open.
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 of a 1.5-Tesla horizontal bore MRI system
may be safely performed.