Magnetic Resonance Imaging (Mri) Safety Information - DePuy Synthes Codman Neuro CERTAS Plus Manual Del Usario

Complications of implanted shunt systems include
mechanical failure, shunt pathway obstruction, infection,
foreign body (allergic) reaction to implants, and CSF
leakage along the implanted shunt pathway.
Clinical signs such as headache, irritability, vomiting,
drowsiness, or mental deterioration might be signs of a
nonfunctioning shunt. Low-grade colonization, usually
with Staph. epidermidis, can cause, after an interval from
a few days to several years, recurrent fevers, anemia,
splenomegaly, and eventually, shunt nephritis or pulmonary
hypertension. An infected shunt system might show
redness, tenderness, or erosion along the shunt pathway.
Accumulation of biological matter within the valve can:
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Adjusting the valve to a performance setting that
is lower than necessary can lead to excessive CSF
drainage, which can cause subdural hematomas, slit-like
ventricles, and in infants, sunken fontanels.
The ventricular catheter can become obstructed by:
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If fibrous adhesions cause the catheter to become
obstructed, use gentle rotation to free the catheter. Do not
remove the catheter with force. If the catheter cannot be
removed without force, it is recommended that it remain in
place, rather than risk intraventricular hemorrhage.
The ventricular catheter can be withdrawn from, or
lost in, the lateral ventricles of the brain if it becomes
detached from the shunt system.
Blunt or sharp trauma to the head in the region of
implant or repetitive manipulation of the implanted valve
might compromise the shunt. Check valve position and
integrity if this occurs.
Magnetic Resonance Imaging (MRI) Safety
Information
The CODMAN CERTAS Tool Kit is considered "MR
Unsafe" in accordance with the American Society for
Testing and Materials (ASTM) Standard F2503-13.
CAUTION: Do not use the CODMAN CERTAS Tool Kit
in the MR suite.
MR Conditional
The CODMAN CERTAS Plus Programmable Valve
is MR Conditional. Non-clinical testing demonstrated
that the CODMAN CERTAS Plus Programmable Valve
is MR Conditional. A patient with this device can be
scanned safely, immediately after placement under the
following conditions:
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206521-001-G-INS.indd 7
cause difficulties adjusting the valve setting with the
Tool Kit
impair the antireflux function
Biological matter
Excessive reduction of ventricle size
Choroid plexus or ventricular wall
Fibrous adhesions, which can bind the catheter to
the choroid plexus or ventricular wall
Static magnetic field of 3-Tesla or less
Maximum spatial gradient magnetic field of
1,000 Gauss/cm (extrapolated) or less.
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