Adverse Events; Magnetic Resonance Imaging (Mri) Safety Information - Codman CERTAS Plus Manual Del Usario

incorrect number may appear in the window of the
Indicator Tool). The Locator Tool must be precisely
aligned with both the valve's direction of flow and the
center of the hard valve mechanism for an accurate
indication reading. Alignment can be more challenging
if tissue thickness is >10 mm above the valve. In
these instances, verify the valve setting with x-ray or
fluoroscopy. See SECTION D: Troubleshooting and
SECTION E: Confirming the Current Valve Setting.

Adverse Events

Devices for shunting CSF might need to be replaced at
any time due to medical reasons or failure of the device.
Keep patients with implanted shunt systems under close
observation for symptoms of shunt failure.
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:
• cause difficulties adjusting the valve setting with the
Tool Kit
• impair the antireflux function
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:
• 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
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The ventricular catheter can be withdrawn from, or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.
7