User's Manual

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CHAPTER 8 Adverse reactions
Adverse reactions
In clinical studies, adverse reactions associated with the Medtronic MiniMed
2007D Implantable Pump included hypoglycemia, diabetic ketoacidosis,
hyperglycemia, skin erosion, infection, abnormal healing, elevated anti-insulin
antibodies, intestinal obstruction, post-operative discomfort and pain. Pump
System malfunctions in order of frequency and seriousness include, insulin
aggregation resulting in insulin under-delivery, Catheter occlusion or tissue
overgrowth, premature depletion of the Pump battery, and failure of Pump
electronics. Adverse events associated with the use of U-400 insulin are
described in the package insert accompanying the insulin medication.
Prevention
The majority of adverse reactions in patients using the Medtronic MiniMed
2007D Implantable Pump System can be prevented by teaching patients
dependable blood glucose monitoring. The patient plays a significant role in
diagnosing and correcting Pump System performance problems. Should Pump
performance change, the patient would be able to detect a change in blood
glucose levels.
Patients should be instructed to contact their physi-
cian’s office, if they experience unresolvable difficul-
ties with the Pump System. Patient visits and
diagnostic procedures may be necessary to correct
these conditions.
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WARNING