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•
Excessive swelling may make it difficult to determine and/or
adjust the performance setting.
If difficulty correctly positioning the Tool persists, see the
o
Tool Kit IFU.
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 anti-reflux 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The ventricular catheter can be withdrawn from, or lost in, the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
MR Conditional
Non-clinical testing demonstrated that the 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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A horizontal cylindrical closed-bore scanner
•
Static magnetic field of 1.5 and 3 T
•
Maximum magnetic field spatial gradient of 1,000 Gauss/cm
(10 T/m)
•
Maximum MR system reported, whole body averaged
specific absorption rate (SAR) of 4-W/kg in the First Level
Controlled Operating Mode of the MR system
5
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