pajunk SPROTTE Standard Mode D'emploi page 11

Procedure-specific complications
Undesirable positioning of the cannula (eg. intravascular, intraneural etc.),
repeating puncture/ redirecting of the cannula, failed procedure.
Clinical complications
• Local and systemic infections
• Neuronal damage (during cannula placement, which may result in tempo-
rary increase in pain, temporary motor weakness, transient back or extremity
pain, nubness and/ or tingling, paraplegia)
• Accidental vascular punctures with corresponding complications (vascular
lesions, bleeding/ bruising, hematoma, vasovagal reactions, intravascular
injection etc.)
• Intra-arterial injection (direct injection into the spinal cord, vertebral artery
or radicular artery include spinal cord infarct, epidural hematoma and brain-
steam hemorrhage, neurological events, vascular complications, thrombosis
or thromboembolism)
• (Accidental) puncture of the dura with corresponding complications
• Dura puncture and liquor loss: post-spinal head or back ache, nausea,
vomitus, neurological damage, epidural abscess
• Anestheticum in the subarachnoidal space: Circulatory disorders,
decrease of the body temperature, urinary retention, respiratory side
effects and complications, extremities weakness, total spinal anesthesia,
cauda-equina syndrome.
• Multiple complications related to the pharmacology of steroids (transient
flushing/ hot flashes, adrenocortical suppression, fluid retention, elevated
blood sugars and mood swings, HPA axis suppression (typically self-limited),
osteoporosis, necrosis of bone, steroid myopathy, weight gain.)
• Reactions on contrast agent (if applied)
• Toxicity of local anesthestic (if applied)
Users must inform patients of complications typically associated with the
procedure.
If complications occur while using the device, follow the protocols of your
organisation. If this does not resolve the complications, or if they are
regarded as serious or untreatable, carefully stop the procedure and remove
invasive device components from the patient.
Warnings
for sterile product:
This is a disposable medical device for use with only one patient.
This device must not be re-used under any circumstances.
This device must not be resterilised under any circumstances.
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