User's Manual

9
CHAPTER 2 Indications and
contraindications
Indications for use
The Medtronic MiniMed 2007D Implantable Insulin Pump System is indicated
for intraperitoneal administration of exogenous insulin in patients with diabetes
mellitus.
The model 2007D Pump can only be used with special U-400 Insulin
formulations specifically labeled for use with the Medtronic MiniMed
Implantable Insulin Pump Infusion System.
Contraindications for use
The Medtronic MiniMed 2007D Implantable Insulin Pump System is
contraindicated in patients who:
• are unwilling or unable to monitor their blood glucose level at least four
times per day.
• are unwilling or unable to make programming modifications to the Pump
based on glucose level readings.
• are unable or unwilling to administer insulin by other means, if necessary.
• are unable or unwilling to comply with the guidance and advice of their
treating physician and other healthcare providers.
• reside at or travel (other than by pressurized commercial aircraft) at
elevations above 8,000 feet.
• have other medical or mental conditions which may place the patient at risk.
• are unwilling or unable to return for routine insulin refills according to their
dosage requirements (approximately once every 90 days).
• present or have a history of sensitivity to titanium alloy, polysulfone or
silicone materials used in the implanted components of the system.