Medtronic SYNCHROMED EL serie Gebrauchsanweisung Seite 17

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8 Precautions
• Clinicians must use strict aseptic techniques during pump refills and side
catheter access port procedures.
• Clinicians and patients should attempt to keep the implant site clean, dry
and protected from external pressure or irritation.
• Clinicians and patients should be aware that in rare instances, the
development of an inflammatory mass at the tip of the implanted catheter
may occur which can result in progressive clinical signs which bear
monitoring. These signs include a progressive change in the character,
quality, or intensity of pain; an increase in the level and degree of pain
despite dose escalation; sensory changes (i.e., numbness, tingling,
burning); hyperesthesia and/or hyperalgesia. Presentations which require
immediate diagnosis include bowel and/or bladder dysfunction,
myelopathy, conus syndrome, gait disturbances or difficulty ambulating
and paraparesis or paralysis. If the presence of an inflammatory mass is
suspected, recommended evaluation should include a review of the
patient history and neurological evaluation, radiological diagnostic
procedures (such as a MRI with contrast) and an appropriate clinical
consultation.
• Patients must avoid physical activities which may damage the implant site
or device.
• Patients must consult with their physician before engaging in activities
involving pressure or temperature changes (e.g., scuba diving, saunas, hot
tubs, hyperbaric chamber, long-duration flights, non-pressurized aircraft,
etc.). Pressure and temperature changes can cause the pump to
temporarily under- or overdispense the drug.
• Patients must avoid "Twiddler's Syndrome" (manipulation of the pump
through the skin) which can cause catheter disconnection, angulation,
kinking, etc.
• Patients must consult their physician if they notice any unusual symptoms
or signs.
• Patients must return to the clinic or physician's office at regular intervals
to monitor system performance.
• Patients must return for refills at the prescribed time. Be aware that at
reservoir volumes of less than 2 ml, pumps may exhibit a decrease in
actual flow rate as compared to the programmed flow rate. This can result
in the potential loss of clinical effect or drug withdrawal symptoms.
• Patients must notify personal and consulting physicians that they have an
implanted pump.
• Patients must notify their physician about travel plans so pump refills can
be arranged.
Medtronic - Kerkrade / PARTNUMBER : 198076-036 SHEETNR. :