By Christopher Snowbeck
St. Paul Pioneer Press
Copyright 2008 St. Paul Pioneer Press
WASHINGTON — Medtronic said Monday it has reached an agreement with the U.S. Food and Drug Administration that could allow the company’s Washington state-based division for external defibrillators to resume unrestricted distribution of products.
Fridley-based Medtronic’s Physio-Control unit indefinitely suspended shipments of external defibrillators and other emergency-response gear in January 2007 because of quality-control problems at a factory in Redmond, Wash. The quality issues were related to manufacturing processes, rather than individual products, and no devices were recalled as a result.
On Friday, Medtronic gave notice to a court in Washington state that it had reached agreement on a consent decree with the FDA regarding quality system improvements for its external defibrillators. Those products, including the LifePak models commonly found in airports, health clubs and other public spaces, are used by paramedics, hospital workers and, in some cases, the general public to rescue those suffering sudden cardiac arrest.
Medtronic said Monday that the agreement with the FDA outlines actions Physio-Control must take in order to resume unrestricted distribution of its external defibrillators.
When Medtronic suspended product shipments, it had just announced plans to spin off the Physio-Control unit because the business wasn’t growing as quickly as others at Medtronic.
“We’re working with the FDA to expedite resumption of full operations,” said Medtronic spokeswoman Marybeth Thorsgaard. “We intend to continue to pursue the plan to divest the Physio-Control business following resolution of these matters.”
The external defibrillator business is separate from the Minnesota-based unit for implantable cardiac defibrillators, which are the top source of revenue at Medtronic.