Brief Statement for US Health Care Providers
PL-19589-00
Issue date: March, 2018
IMPORTANT SAFETY INFORMATION FOR PROMETRA DRUG DELIVERY SYSTEMS - BRIEF STATEMENT
Product technical manuals and the appropriate drug labeling must be reviewed prior to use for detailed disclosure. Clinicians implanting, programming, accessing, or maintaining implanted programmable pumps must comply with the instructions for use.
Indications: The Prometra II Programmable Pump is indicated for intrathecal infusion of Infumorph® (preservative free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (Sodium Chloride Injection, USP).
Drug Information: See Infumorph® labeling for indications, contraindications, warnings, precautions, dosage, administration, screening procedures and under/over dose symptoms and management. Patients should be informed of signs and symptoms that require medical attention.
Contraindications: Implantation is contraindicated in the presence of infection; insufficient body size; incompatible spinal anatomy or obstruction of CSF flow; implant depth>2.5cm below skin; allergies to catheter or pump materials; intolerance to implanted devices; medical history of substance abuse deemed to prohibit intrathecal drug administration; occupations with exposure to high current industrial equipment, powerful magnets or transmitting towers; hyperbaric exposure.
Warnings: FAILURE TO EMPTY THE PUMP PRIOR TO EXPOSURE TO MRI ENVIRONMENT COULD RESULT IN DRUG OVERDOSE THAT COULD LEAD TO SERIOUS PATIENT INJURY OR DEATH; USE OF UNAPPROVED DRUGS (e.g., DRUG COCKTAILS, PHARMACY COMPOUNDED DRUGS, MORPHINE WITH PRESERVATIVES, ETC.) WITH THE PROMETRA II PUMP COULD RESULT IN PUMP FAILURE AND/OR SERIOUS ADVERSE EVENTS INCLUDING DEATH; Prometra System is MRI Conditional - consult the labeling for MRI information.
Precautions: An inflammatory mass resulting in serious neurological impairment, including paralysis, may occur at tip of catheter. Monitor patients carefully for new neurological signs or symptoms. Electromagnetic interference may interfere with Programmer telemetry during pump programming. Pain on injection may be an early sign of infection. Safety and effectiveness for use in pediatric patients under 22 years old has not been investigated or established.
Adverse Events: Pocket seroma/hematoma with or without infection, pump site skin erosion, pump rotation/migration/flipping or twisting, adverse reaction to pump materials, granuloma; infection in intrathecal space, including meningitis, nerve damage.
For full prescribing information and full disclosure of contraindications, warnings, precautions, adverse events and MRI Instructions, please call Flowonix at 855-356-9665 and/or consult Flowonix website at Flowonix.com
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.