User's Manual

Warnings and precautions
82
Diagnostic ultrasound
The Medtronic MiniMed 2007D Implantable Insulin Pump System has been
tested during diagnostic ultrasound procedures. These procedures have no effect
on Pump performance. However, patients should be instructed to test the Pump
function (e.g., self test) after such procedures to determine that the Pump and
PPC are operating properly. If the system is not performing correctly, contact
Medtronic MiniMed.
Ultrasound therapy
The Medtronic MiniMed 2007D Implantable Insulin Pump System should not be
exposed to therapeutic ultrasound procedures such as lithotripsy. Exposure to
ultrasound therapy may damage the Pump, and not be immediately apparent.
Diagnostic radiation
The Medtronic MiniMed 2007D Implantable Insulin Pump System has been
tested during diagnostic radiation procedures, such as Computed Tomography
and X-ray. These procedures have no effect on Pump performance. However,
patients should be instructed to test the Pump function (e.g., self test) after such
procedures to determine that the Pump and PPC are operating properly. If the
system is not performing correctly, contact Medtronic MiniMed.
Elevated anti-insulin antibodies
The results of clinical investigations suggest a small population of patients may
develop anti-insulin antibodies when using the Medtronic MiniMed 2007D
Implantable Pump System and U-400 insulin. Patients with multiple autoimmune
disorders may be more susceptible to developing high titers of anti-insulin
antibodies, which in turn may cause symptoms. There was no correlation
between length of exposure to the study drug and the resultant titer of anti-insulin
antibodies. Elevated levels of anti-insulin antibodies alone have been proven not
to interfere with diabetes management using continuous intraperitoneal insulin
infusion with this system.