PROMETRA® II PROGRAMMABLE PUMP
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Possible Risks Associated with Intrathecal Catheter:
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Catheter disconnection
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Catheter kinking
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Catheter fracture
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Catheter migration (unrelated to surgical complication)
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Cerebrospinal fluid (CSF) leak
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Disconnection
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Erosion
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Fibrosis
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Infection in intrathecal space, including meningitis
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Inflammatory mass formation (e.g., granuloma)
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Malpositioning
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Nerve damage
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Pain on injection
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Poor radiopacity
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Post dural puncture headache
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Reaction to catheter materials
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Reversible or irreversible partial or complete occlusions
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Spinal cord pressure leading to paralysis
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Spinal cord trauma, perforation, laceration
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Subcutaneous catheter tract infection
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Subcutaneous tunnel infection
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Tears/breaks
In rare instances, the development of an inflammatory mass at the tip of the implanted catheter may
occur, which can result in serious neurological impairment. Patients should be monitored carefully at
each visit for any new neurological signs or symptoms, including:
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progressive change in the character, quality, or intensity of pain
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an increase in the level and degree of pain despite dose escalation
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sensory changes (i.e., numbness, tingling, burning)
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hyperesthesia and/or hyperalgesa
Presentations that require immediate diagnosis include
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bowel and/or bladder dysfunction
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myelopathy
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conus syndrome
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gait disturbances or difficulty ambulating
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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
CT scan with contrast) and appropriate clinical consultation.
