Possible Complications - Promedon VICTO+ Instructions D'utilisation

are familiar with the use of the device and its
surgical technique. Promedon recommends
reviewing the information
watching an overview of the device in the
official surgical procedure videos (uploaded
to the official website) prior to performing the
surgical procedure.
Adequate precautions must be taken to
avoid contamination during the intraoperative
procedure.
Operating room conditions should be in
accordance with hospital, administrative,
and/or local government policy.
After use, the
and packaging should be disposed of in
accordance with hospital, administrative,
and/or local government policy.
MAGNETIC RESONANCE (MR)
ENVIRONMENT
Non-clinical testing performed in the worst-
case product has demonstrated that VICTO+
implant is MR conditional.
this device can be safely scanned in an MR
system meeting the following conditions:
• Static magnetic field of 1.5 Tesla and 3
Tesla
• Maximum spatial field gradient of 12,800
G/cm (128 t/m)
• Maximum force product of 231 T²/m
• Theoretically estimated maximum whole
body average (WBA) specific absorption
rate (SAR) of < 2 W/kg (normal operating
mode)
Under the scan conditions defined above,
the VICTO+ implant is expected to produce a
maximum temperature rise of less than
1.0°C (2 W/kg, 1.5 Tesla) RF-related temperature
increase with a background temperature
increase of ≈ 1.0°C (2 W/kg, 1.5 Tesla)
0.9°C (2 W/kg, 3 Tesla) RF-related temperature
increase with a background temperature
increase of ≈ 1.0°C (2 W/kg, 3 Tesla)
after 15 minutes of continuous scanning.
In non-clinical testing, the visual artifact
caused by the device extends approximately
herein
non-implanted product
A patient with
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
and
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
removal of the device.
Infections that do not respond to antibiotic
treatment and chronic pain related to 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
• Haematuria
• Abnormal detrusor function
• Urethral atrophy
• Urethral constriction by fibrous tissue
• Bladder neck/urethral closure
• Infection
• Mechanical failure
• Explantation
• Pain/discomfort
• Device malfunction
• Delayed wound healing
• Migration
• Recurrent incontinence
• Bladder spasm
• Difficult activation
• Tissue damage
• Swelling
• Fistula formation
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