Manual Part 2

115
CHAPTER 8 Adverse Reactions
Adverse reactions
In clinical studies, adverse reactions associated with the Medtronic Min-
iMed 2007C Implantable Pump included hypoglycemia, diabetic ketoaci-
dosis, hyperglycemia, skin erosion, infection, abnormal healing, elevated
anti-insulin antibodies, intestinal obstruction, post-operative discomfort
and pain, and corrective surgery for Pump and Catheter malfunctions.
Pump System malfunctions in order of frequency and seriousness include
insulin aggregation resulting in Pump 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 Aventis
HOE 21 PH U-400 insulin are described in the package insert accompa-
nying the insulin medication.
Dmp9196021-011_c.book Page 115 Wednesday, April 3, 2002 5:04 PM