System Description; Pump - Medtronic SYNCHROMED EL serie Gebrauchsanweisung

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14 Adverse Events; System Description
• Improper injection through the side catheter access port which can lead to
a clinically significant or fatal drug overdose.
• Injection into pocket or subcutaneous tissue.
Other:
• Body rejection phenomena.
• Complications due to the interaction of the SynchroMed
System with unusual physiological variations in patients.
• Surgical replacement of the pump or catheters due to any of the
complications.
• Complications due to other intervening acts.

SYSTEM DESCRIPTION

Use of the SynchroMed ®
pump and catheter to provide a fluid pathway for drug administration. Accessories
include surgical instrumentation, an external programmer, Refill Kits, and Catheter
Access Port Kits.
The following subsections briefly describe the system component options.

Pump

SynchroMed ® EL programmable pumps are implantable, battery-powered
devices that store and dispense drugs according to instructions received from the
Medtronic programmer.
The pump has three sealed chambers: one contains the reservoir propellant, the
second contains a hybrid electronic module and battery, and the third contains a
peristaltic pump and drug reservoir. The peristaltic pump forces the drug from
the reservoir through elastomeric tubing into a catheter to the administration
site. Electronic circuitry controls the pumping action. The reservoir valve stops
the further introduction of fluid into the reservoir when the reservoir capacity is
reached.
Some pumps feature a side catheter access port which allows percutaneous entry,
via a 25-gauge needle, into the implanted catheter for drug administration and
some diagnostic purposes. The side catheter access port allows injection through
the same catheter that delivers infusions from the SynchroMed
The side catheter access port housing is made of silicone rubber and titanium; it
contains a self-sealing septum, needle stop, infusion pathway, titanium catheter
port, titanium screen and an in-line valve. The titanium screen is designed to
allow entry of a 25-gauge needle (or smaller) into the side catheter access port
septum. The in-line valve directs infusion flow from the side catheter access port
toward the catheter infusion site and prevents fluid from passing back to the
pump. When the pressure from the side catheter access port injection is removed,
the infusion from the pump continues into the catheter.
Medtronic - Kerkrade / PARTNUMBER :
EL Infusion System requires the selection of an implantable
198076-036
® EL Infusion
® EL pump.
SHEETNR. :