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[IP] Medtronic: Insulin Pumps Not Waterproof

Medtronic: Insulin Pumps Not Waterproof
9/10/2003 2:59:00 PM

MINNEAPOLIS, Sep 10, 2003 (AP Online via COMTEX) -- Medtronic Inc. warned 
 doctors and patients that two of its insulin pumps that were sold as waterproof
can develop stress cracks over time and take in water. 

The company said people should not wear Medtronic MiniMed Paradigm 511 and 
Paradigm 512 insulin pumps while swimming or participating in other water 
activities where the pump would be submerged because the water can cause the 
pump to shut down. 

Spokeswoman Deanne McLaughlin said Wednesday that the pumps, launched a year 
ago, were tested in 3-foot-deep water for 30 minutes at the MiniMed 
manufacturing plant in Northridge, Calif. They were considered waterproof when 
shipped, she said. 

"But over time, as people have used the pumps, the Paradigm has developed 
stress cracks," McLaughlin said Wednesday. This summer, when people began 
swimming more, Medtronic noticed more pumps were being returned due to water 
exposure, she said. 

"It's OK if it's splashed or dunked in water briefly," McLaughlin said. 

Medtronic also recommends that patients disconnect the pumps when showering. 

An insulin pump consists of a pump reservoir filled with insulin, a small 
battery operated pump and a computer chip that allows the user to control how 
much insulin the pump delivers. It is contained in a plastic case about the 
size of a beeper connected to the body by a thin plastic tube inserted just 
under the skin. 

The pump delivers a small amount of insulin continuously to keep blood sugar 
levels stable between meals and overnight. The user sets the pump to deliver 
additional insulin when food is eaten. 

If the pump turns off due to water damage, the pump's screen will go blank and 
 its activation buttons won't work. If that happens, patients should check their
blood sugar levels and treat any high blood glucose with an insulin injection, 
the company said. 

"If there's anything that happens to the pump with water, we definitely will 
replace the pump," McLaughlin said. 

Medtronic voluntarily notified the Food and Drug Administration of the problem 
and sent out letters to physicians and patients using the pumps. 

"Right now, we are going through and changing everything on our Web site to 
 reflect (the change) and we're reviewing other sites that may have it to notify
them," McLaughlin said. 

Medtronic hopes to develop a future model that will remain waterproof over 
time, she said.
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