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Idiomas disponibles
Idiomas disponibles
in non-clinical testing, the image artifact
caused by the device extends approximately
18.3 mm from the victo implant at the "port
of the pump" when imaged with a gradient
echo pulse sequence and a 3 tesla mr
system.
POSSIbLE COmPLICATIONS
the use of victo may result in complications
associated with the methods used during the
surgical procedure or reaction to the foreign
body.
the efficacy of the device may be reduced
in patients who had been treated with
radiotherapy for local recurrence of prostate
cancer.
some complications may require complete or
partial removal of the device.
infections that do not respond to antibiotic
treatment, chronic pain related with the device
failure may require the removal of the device.
complications reported with this or other
surgical procedures for the treatment of
incontinence include:
• urinary retention due to inability of the
patient to empty the cuff correctly
• Fluid loss due to disruption of a connection
or a pinhole leak
• cuff and/or pump erosion (characterized
by pain, haematuria, dysuria, and recurrent
incontinence)
• abnormal detrusor function
• urethral atrophy
• Bladder neck / urethral closure
• infection
• mechanical failure
• explantation
• pain/discomfort
• device malfunction
• delayed wound healing
• migration
• recurrent incontinence
• Bladder spasm
• difficult activation
• tissue erosion
• swelling
• Fistula formation
• Haematoma
• Hydrocele
• tissue erosion/infection
• patient dissatisfaction
• positional incontinence
• Wound infection
• urinary retention
• difficult deactivation
clinical literature reports that a small
percentage
of
experiencing incontinence after an artificial
urinary sphincter placement.
cOMpOnentS
PAcKAgiNg
the
starter
kit,
adjustment kit are supplied sterile and
packaged in double plastic pouches to
enable visualization of the device. each kit
is delivered in a labeled cardboard box for
additional protection.
INDIvIDUAL COmPONENTS
StArtEr Kit
the victo implant comes as one-piece
device ready to be filled with a sterile saline
solution at the time of surgery.
there are four cuff sizes (3.7cm; 4.0cm;
4.5cm and 5.0cm).
the kit also contains the necessary materials
to set up the device before to be implanted. it
includes the following disposable items:
• 2 (two) injection non-coring needles: 25g
x 5/8"
• 2 (two) 10 ml syringes
ACCESSOriES Kit
the accessories kit is delivered to enable
the implantation procedure. it includes the
following disposable items:
· 5 ·
patients
may
continue
accessories
kit,
and
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