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.