Drug Complications; Procedural Complications - Medtronic SYNCHROMED EL serie Gebrauchsanweisung

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• free-floating catheter in the CSF,
• underinfusion of the drug,
• CSF leak leading to spinal headache, CSF subcutaneous collection, or rare
Central Nervous System pressure-related problems,
• damage to the spinal cord, or
• need for surgical replacement/revision of catheter.

Drug Complications

• Local and systemic drug toxicity and related side effects.
• Complications due to use of unapproved drugs with the system.
• Complications due to using drugs not in accordance with the drug
labeling.

Procedural Complications

Surgical:
• Pump implanted upside down.
• Pocket seroma, hematoma, erosion, or infection.
• Lumbar puncture-type headache.
• CSF leak leading to spinal headache, CSF subcutaneous collection, or rare
Central Nervous System pressure-related problems.
• Radiculitis.
• Arachnoiditis.
• Bleeding.
• Damage to the spinal cord.
• Meningitis.
• Spinal headache.
• Medical complications.
• Complications from anesthesia.
• Damage to the pump, catheter and catheter access system due to improper
handling and filling before, during, or after implantation.
Fill/Refill/Side Catheter Access Port/Programming:
• Infection.
• Meningitis.
• Fill, refill, side catheter access port, or programming error which may lead
to tissue damage or a clinically significant or fatal drug under- or
overdose, or drug withdrawal.
• Reservoir contamination.
• Complications related to drug withdrawal.
• Activation of the reservoir valve which may lead to procedural delays.
• Damage to the pump, catheter and catheter access system due to improper
handling and filling before, during, or after implantation.
Medtronic - Kerkrade / PARTNUMBER :
Adverse Events
198076-036 SHEETNR. :
13