Installation Instructions Part 1

Indications and Contraindications
22
• 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 accord-
ing to their dosage requirements (approximately once every 2-3
months).
• present or have a history of sensitivity to titanium alloy,
polysulfone or silicone materials used in the implanted compo-
nents of the system.
Possible adverse effects
The MiniMed 2001 Implantable Insulin Pump System has undergone an
extensive clinical evaluation. The model 2007C is essentially identical to
the model 2001 Pump except for the use of updated electronics and bat-
tery. Evaluation of components used in the MiniMed 2001 System
spanned a period of ten years and involved approximately 650 patients
from both the U.S. and Europe. Although clinically relevant over-delivery
of insulin did not occur during the ten 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.
Dmp9196021-011_c.book Page 22 Thursday, April 4, 2002 8:15 AM