Product Order Information - Integra NeuroSciences NL850-500V Manual Del Usuario

ventricular wall or choroid plexus.
Less commonly, the catheter may be
obstructed by the excessive reduction of
ventricular size to slit-like proportions.
Functional failure of the drainage system
due to separation of its component
parts can result in serious complica-
tions. Ventricular catheters may migrate
into the lateral ventricles.
Infection is a common and serious
complication with drainage systems
and is most frequently caused by skin
contaminants. Septicemia, which
occurs most frequently in debilitated
infants, can result from infections
anywhere in the body and may develop
with few or no symptoms. Septicemia
may also occur as a result of a wound
infection. The presence of a foreign
body (i.e., the catheter system) may
trigger ventriculitis or a dormant
meningitis.
Lesions developing from the breakdown
of skin or tissue around the drainage
system may also serve as foci of
serious infections. In the event of an
infection, replacement of the drainage
system is indicated in addition to the
appropriate antibiotic therapy.
Excessive lowering of intracranial
pressure may result in complications,
particularly in the infant. These include:
subdural hematomas, markedly sunken
fontanelles, overriding of cranial bones
and conversion of a communicating to
a noncommunicating hydrocephalus
due to obstruction of the Aqueduct of
Sylvius.
Failure of the drainage system may be
evidenced by continuing symptoms of
increased ICP .
Product Information
Disclosure
Integra NeuroSciences has
exercised reasonable care in the
choice of materials and
manufacture of this product. Integra
NeuroSciences excludes all
warranties, whether expressed or
implied by operation of law or
otherwise, including, but not limited
to any implied warranties of
merchantability or fitness for a
particular purpose. Integra
NeuroSciences shall not be liable for
any incidental or consequential loss,
damage, or expense, directly or
indirectly arising from use of this
product. Integra NeuroSciences
neither assumes nor authorizes any
other person to assume for it any
other or additional liability or
responsibility in connection with this
device.
4

Product Order Information

All products can be ordered through
your Integra NeuroSciences Neuro
Specialist or customer service
representative or by contacting :
Integra NeuroSciences
311 Enterprise Drive
Plainsboro, NJ 08536 USA
Telephone: 1-800-654-2873
Outside the US: 1-609-275-0500
Fax: 609-275-5363
or
Integra NeuroSciences
Newbury Road, Andover
Hampshire SP10 4DR England
Tel: +44(0) 1264-345-700
Fax: +44 (0) 1264-332-113
Caution: Federal (USA) law restricts
this device to sale by or on the order
of a physician. Do not use if the
package has been opened or
damaged.
Symbols Used On Labeling
See instructions for use
Expiration date
2 Do not reuse after
opening
Lot number
LOT
Sterile unless package is
STERILE EO
opened or damaged.
Method of sterilization-
ethylene oxide.
Product complies with
0123
requirements of directive
93/42/EEC for medical
devices.