ST. PAUL, Minn. -- Fridley (Minn.) based Medtronic and the U.S. Food and Drug Administration have reached an agreement that could allow the company's Washington-based division for external defibrillators to resume unrestricted distribution of products, the company said today.
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 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 aid those suffering sudden cardiac arrest.
Medtronic said in a statement today that the agreement with FDA outlines actions Physio-Control must take to resume unrestricted distribution of its external defibrillators.
When Medtronic suspended product shipments, the company had only just announced plans to spin off the Physio-Control unit because the business wasn't growing as quickly as others at Medtronic. The external defibrillator business is separate from the Minnesota-based unit for implantable cardiac defibrillators.