11. Precautions For The Daily Life Of The Patient; 12. Complications / Side Eff Ects; Obstruction; Infection - Sophysa POLARIS SPV-140 Gebrauchsanweisung

Magnet back and forth quickly along the axis of the current position
D. Slide the
to unlock the valve rotor. Ensure that the Magnet remains in the plane of
the valve. Repeat this procedure several times if necessary until the valve rotor
is unlocked. Then replace the Magnet in a position centered over the valve.
Magnet until the desired new operating pressure position is
E. Then turn the
reached. Confi rm the new setting using the Compass, or with an X-ray.
The implantation of a valve not performed in the recommended conditions
(cf. §10 - Implantation Technique) may lead to a Compass reading of a pressure value
inconsistent with the patient record or the clinical status of the patient.
In this case, an X-ray removes any doubt. It is the absolute proof of a successful
adjustment and the correct direction of the implantation.
Finally, pressure adjustment is impossible if the valve is positioned the wrong way
up (upside down).

11. Precautions for the Daily Life of the Patient

A Patient Identifi cation Card is supplied with the Polaris® valve. It enables the
neurosurgeon to consult and update information relating to the implanted device
(reference, operating pressure, implantation site, etc.) systematically and to ensure
that the illness is properly monitored.
P :
RECAUTION
T
HE PATIENT SHOULD BE WARNED THAT IT IS IMPORTANT TO CARRY HIS
C (PIC) .
ARD AT ALL TIMES
T
HIS CARD GIVES INFORMATION ON THE MEDICAL SITUATION OF THE PATIENT TO ALL MEDICAL
.
PERSONNEL
The magnetic self-locking system of the Polaris® valve is designed to make
the magnetic rotor insensitive to the infl uence of standard magnetic fi elds.
As a result, the following are not likely to aff ect the valve operating pressure:
- magnetic fi elds generated by walk-through scanners in airports, microwave
ovens, cordless telephones, high tension cables, and TV
- permanent household magnets such as those present in toys, audio headsets
and loudspeakers
- magnetic fi elds created by electric motors operating in equipment such as
razors, hairdryers, lawn mowers, etc.
The doctor is responsible for informing the patient or his/her family that the person
fi tted with a shunt must avoid any activity that may subject this shunt to direct
shocks (violent sports, etc.) as these are likely to damage it.
P :
RECAUTION
T
HE PATIENT MUST BE WARNED THAT VIBRATIONS DUE TO THE
BECAUSE OF THE IMPLANTATION OF THE VALVE ON THE SKULL

12. Complications / Side eff ects

Complications which may result from the implantation of a CSF shunt system include
the inherent risks in the use of drugs, any surgical intervention and the insertion of
a foreign body.
P :
RECAUTION
P
ATIENTS TREATED WITH A SHUNT SYSTEM MUST BE CLOSELY MONITORED POST
.
TO DETECT ANY SIGNS OF COMPLICATIONS EARLY
The doctor is responsible for educating the patient or his/her family about CSF shunt
systems, in particular describing the complications linked to implanted shunt systems
as well as giving explanations about possible alternative therapies.
The main complications of shunts are obstruction, infection and over-drainage.
These complications require rapid intervention by the doctor.
/ P I
HER ATIENT DENTIFICATION
CSF
FLOW MAY POSSIBLY BE FELT
.
-
OPERATIVELY IN ORDER
17

Obstruction

Obstruction is the most frequent complication in shunt systems. It can
occur at any point in a shunt.
The ventricular catheter can be obstructed by a blood clot, cerebral tissue or even
tumoral cells.
The end of the ventricular catheter can also become embedded in the choroid
plexus or in the ventricular wall, either directly or following a collapse of the walls,
a consequence of over-drainage.
The cardiac catheter can be colonized by a thrombus while the appearance of a clot
around the catheter could cause an embolism in the pulmonary circulation.
The peritoneal catheter may become obstructed by the peritoneum or by intestinal
loops.
Loss of patency in a shunt may also be the result of an obstruction by fragments of
cerebral tissue or by biological deposits (protein deposits, etc.)
Obstruction of the shunt will quickly result in the reappearance of the signs and
symptoms of intracranial hypertension.
These signs and symptoms vary from patient to patient and over time.
In infants and young children, the symptoms may be an abnormal increase in
the size of the skull, a bulge in the fontanelles, dilation of the scalp veins, vomiting,
irritability with a lack of attention, downward deviation of the eyes, and sometimes
convulsions.
In older children and adults, intracranial hypertension due to hydrocephalus may
be the cause of headaches, vomiting, blurred vision, diplopia, drowsiness, slowing
of movements, gait disorders or psychomotor slowing which could lead to total
invalidity.
If an obstruction is confi rmed and a patency test does not make it possible
to reduce the obstruction, revision surgery or removal of the device must
be envisaged.

Infection

Chronic malfunction of the shunt could cause a leak and a discharge of CSF along its
length increasing the risk of infection.
Local or systemic infection is another possible complication of CSF shunt systems.
It is generally secondary to the colonization of the shunt by cutaneous germs.
Nevertheless, as for all foreign bodies, any local or systemic infection can colonize
the shunt. Erythema, edema and skin erosions along the length of the shunt may be
an indication of an infection of the shunt system.
Prolonged, unexplained fever may also be the result of a shunt system infection.
Septicemia, favored by an alteration in general status, can start from a shunt
infection.
If there is infection, removal of the system is indicated in conjunction with
the start of a specifi c treatment by a general or intrathecal route.

Overdrainage

Overdrainage can result in a collapse of the ventricles (slit ventricle
syndrome) and the appearance of a subdural hematoma.
In children, depression of the fontanelles, overlapping of the skull bones,
even a craniostenosis or a change from communicating hydrocephalus to obstructive
hydrocephalus by stenosis of the Aqueduct of Sylvius could occur.
Adults can present with a variety of symptoms such as vomiting, auditory or visual
disorders, drowsiness or even headaches in the upright position but which improve
in the supine position.