MEDSTREAM
™
Programmable Infusion System
Essential Prescribing Information:
Product instructions for use and appropriate drug labeling must be reviewed prior to use
for detailed disclosure.
INDICATIONS:
The MEDSTREAM
™
Programmable Infusion System is indicated for the chronic intrathecal
infusion of preservative-free morphine sulfate sterile solution (4.0 pH to 7.0 pH) in the
treatment of chronic, intractable pain (benign or malignant), and Baclofen injection sterile
solution (5.0 pH to 7.0 pH) in the treatment of severe spasticity.
CONTRAINDICATIONS:
The pump is contraindicated under the following conditions: in the presence of active or
incompletely treated infection; if the top surface of the implanted pump will be more
than 2.5 cm from the surface of the skin; if the patient’s body size is insufficient to accept
the bulk and weight of the pump; when conservative treatment is appropriate; and in the
presence of spinal anomalies that might complicate the implantation and fixation of an
intraspinal catheter. In addition, observe all contraindications relating to the use of the
prescribed drug.
Thoroughly review product instructions for use for a detailed listing of Indications,
Contraindications, Warnings, Precautions and Adverse Events.
LIMITED WARRANTY AND DISCLAIMER:
CODMAN products are sold with a limited warranty to the original purchaser against
defects in workmanship and materials. Any other express or implied warranties, including
warranties of merchantability or fitness, are hereby disclaimed.
CAUTION:
This device is restricted to sale by or on the order of a physician (or properly licensed
practitioner) who has appropriate training or experience.
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Essential Prescribing Information
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