Stay Curious. Stay Connected.
MailNewsletters♡Donate Now
Sign up
*Password must be at least 8 characters and contain one uppercase letter, one lowercase letter, one number and one symbol.
Already have an account?
By submitting, you consent that you are at least 18 years of age and to receive information about MPR's or APMG entities' programs and offerings. The personally identifying information you provide will not be sold, shared, or used for purposes other than to communicate with you about MPR, APMG entities, and its sponsors. You may opt-out at any time clicking the unsubscribe link at the bottom of any email communication. View our Privacy Policy.
Sign in to your profile
Forgot Password?
New to MPR News?
Welcome back
to news
for you
Reset Password

Enter the username on file and we'll send you a code to reset your password.

Still require assistance or not sure what your User Name is?
Welcome back
to news
for you
Email Verification

A verification code has been emailed to

Still awaiting the code?
Martin Moylan
ST. PAUL, Minn.

FDA joins Medtronic on drug pump warning

Go Deeper.

Create an account or log in to save stories.

Log inCreate a free Account

Like this?

Thanks for liking this story! We have added it to a list of your favorite stories.

Show me!

The Food and Drug Administration is joining Medtronic to warn that some of the company's drug infusion pumps may fail to properly deliver medicines.

Fridley, Minn.-based Medtronic sent an urgent safety notice to doctors last month that motors may stall on some SynchroMed pumps, potentially leading to a return of symptoms and possibly death. The company is not pulling the devices from the market.

The company is repeating previous warnings the pumps are more likely to fail if used with unapproved drugs, Medtronic spokeswoman Donna Marquard said.

"This is not a new issue. Our pump continues to demonstrate reliability at or above expected levels and we remain confident in the ability to deliver safe and effective therapy to those who need it," Marquard said.

Medtronic and now the FDA say only approved drugs should be used with the pumps and patients should be closely monitored for the return of symptoms. The pumps are almost three-times more likely to stall and not properly administer medications when used with unapproved drugs.

Based on data from Medtronic's Implantable Systems Performance Registry, the overall failure rate of the SynchroMed II pump 78 months after implant is 2.4 percent when used to dispense approved drugs, and 7 percent when used to dispense unapproved drugs.