The Prometra® drug delivery system is surgically implanted under the skin, and all surgery carries some risk. Additionally, there is a risk of infection and spinal fluid leakage.
Once the device is implanted, there is a risk of complications with the device which may require removal of the device. Drug overdose or underdose may occur from device complications, and may have serious or life-threatening effects.
Possible complications may also include movement of the device within the body or wearing through the skin. Parts of the implantable pump system, including the catheter or pump could leak, tear, kink, or become disconnected. It is also possible that the pump may fail to function because of a battery problem or a component failure. In some cases, inflammatory masses have been seen at the tip of the catheter, which may lead to complications including paralysis.
Speak to your doctor regarding possible risks with the Prometra drug delivery system.