User's Manual

Indications and contraindications
10
Possible adverse effects
The model 2007D is essentially identical to the model 2007C Pump except for
the change in gas needed to maintain negative pressure in the reservoir.
Evaluation of components used in the Medtronic MiniMed 2007C system has
spanned a period of approximately 4 years and involved approximately 380
patients from both the U.S. and Europe. Although clinically relevant over-
delivery of insulin did not occur during the 4 year evaluation period, there is a
potential for such an occurrence.
The following are specific adverse effects which should be understood by the
physician and explained to the patient. These do not include all adverse effects
which can occur with surgery in general or with the use of this device, but are
important considerations, particularly in the treatment of diabetic patients. The
general surgical risks, as well as operative site cosmetic risks, should be
explained to the patient prior to surgery.
• Abdominal Pain • Foreign Body Reaction
• Inflammation at Refill Site • Skin Erosion
• Infection • Pocket Lymph Edema
• Necrosis • Hyperglycemia
• Hypoglycemia • Ketoacidosis