User Manual

Warnings and Precautions
66
Adverse reactions
In clinical studies, adverse reactions associated with the Medtronic Min-
iMed 2007 Implantable Insulin Pump System included hypoglycemia,
diabetic ketoacidosis hyperglycemia skin erosion, infection, abnormal
healing, elevated anti-insulin antibodies, intestinal obstruction, post-oper-
ative discomfort and pain, and corrective surgery for Pump and Catheter
malfunctions. Malfunctions in the order of frequency and seriousness
include insulin aggregation resulting in Pump under-delivery, Catheter
occlusion or tissue overgrowth, early Pump battery depletion (e.g., less
than six years after implantation) and electronic Pump failure. Adverse
events associated with the use of Aventis HOE 21 PH U-400 insulin are
described in the package insert accompanying the insulin medication.
Hyperglycemia
Your Implantable Insulin Pump uses a special short-acting insulin, so
your body will not have any reserve of long-acting insulin. Interruption of
insulin delivery (due to Pump malfunction or clogging of the Catheter) or
the sudden onset of stress (emotional upset, infection, etc.) may result in a
rapid rise of blood sugar levels, and possibly the development of diabetic
ketoacidosis (DKA). Check your blood sugar levels, and your urine for
ketones, if you suspect a high glucose level. Supplemental insulin deliv-
ered by conventional means may be required. Establish a protocol with
your doctor for rapidly identifying and treating hyperglycemia to avoid
the onset of DKA.
Hypoglycemia
The best method for identifying hypoglycemia is testing your blood sugar
levels. Establish a protocol with your doctor for identifying and treating
symptoms of hypoglycemia to avoid an insulin reaction.