PROMETRA® II PROGRAMMABLE PUMP
Page 6 of 38
The pump is supplied with a Catheter Access needle and a non-coring Refill needle for priming the
pump at implantation. The Patient Information packet contains a patient guide and two patient
implant cards to be completed and given to the patient. Additionally, a federally-mandated patient
device tracking form is included and needs to be completed and returned to Flowonix.
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
Refer to the Infumorph labeling for a complete list of indications, contraindications, warnings,
precautions, dosage administration information and screening procedures.
Contraindications
Implantation of this device is contraindicated when:
•
The presence of infection is known or suspected.
•
The patient’s body size or anatomy is insufficient to accommodate the size of the implanted pump
or catheter.
•
The pump cannot be implanted 2.5 cm (1 in.) or less from the surface of the skin. Deeper implants
could interfere with septum access or telemetry.
•
The patient is known or is suspected to be allergic to materials contained in the catheter: silicone
elastomers, barium sulfate, tungsten, polyacetal resin, ink, stainless steel, hydroglide hydro gel
coating, or plastic needle hubs (polypropylene and acrylic based).
•
The patient is known or is suspected to be allergic to materials contained in the pump: titanium,
silicone elastomers, polyphenylsulfone, silicone adhesive, polyvinylidene fluoride, MP35N metal
(nickel-cobalt-chromium-molybdenum alloy), or stainless steel (AL29-4, 316L).
•
The patient has exhibited a prior intolerance to implanted devices.
•
The patient has a spinal column anatomy that would obstruct cerebrospinal fluid flow or that
would prevent intraspinal drug administration.
•
The patient has emotional, psychiatric or substance abuse problems that are deemed to prohibit
intrathecal drug administration.
•
Contraindications relating to Infumorph must be observed and followed per the approved drug
labeling.
