Adverse Events; Pump Complications; Catheter Complications - Medtronic SYNCHROMED EL serie Gebrauchsanweisung

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Adverse Events

ADVERSE EVENTS
The adverse events associated with the use of this device may include, but may
not be limited to, the following:

Pump Complications

Cessation of therapy, due to battery depletion or random component failure,
which may result in:
• return of underlying symptoms,
• drug withdrawal symptoms, or
• need for surgical removal of pump.
Change in flow performance characteristics, due to component failure or
changes over time, which may result in:
• underinfusion of the drug,
• return of underlying symptoms,
• drug withdrawal symptoms,
• overinfusion of the drug,
• drug overdose, or
• need for surgical removal of pump.
Inability to program the device, due to programmer failure or loss of telemetry,
which may result in:
• inability to change programmed delivery rate,
• inability to terminate drug flow via telemetry,
• delay of therapy, under- or overdose, or drug withdrawal symptoms, or
• need for surgical removal of pump.
Side catheter access port failure, due to random component failure, which may
result in:
• underinfusion of drug, or
• need for surgical removal of the pump.

Catheter Complications

Change in catheter performance, due to catheter kinking, catheter disconnection,
catheter leakage, catheter breakage, complete or partial catheter occlusion,
catheter dislodgement or migration, or catheter fibrosis or hygroma, which may
result in:
• delivery of drug into pocket or subcutaneous tissue,
• drug withdrawal symptoms,
• return of underlying symptoms,
Medtronic - Kerkrade / PARTNUMBER : 198076-036 SHEETNR. :