Medtronic’s Defibrillator Operations Placed Under Consent Decree

Medtronic may continue to ship some LifePak external defibrillators for emergency use under a consent decree it agreed to with the FDA for its troubled Physio-Control division, which manufactures defibrillators in Redmond, Wash.

According to court documents filed in the U.S. District Court for the Western District of Washington, the company may still ship LifePak models 12, 20 and 1000 to existing customers if they have an immediate need for them. This is the second consent decree for Medtronic’s defibrillator business. The first one dates back to 1992 and was lifted in 1998.

Last year, after Medtronic said it intended to spin off the division, it halted U.S. shipments from the Redmond plant for undisclosed GMP deficiencies. The firm resumed emergency shipments from the division in mid-2007.

Under the latest decree, which still needs court approval, LifePak customers would need to certify that their facilities have been standardized to Physio-Control defibrillators and that the purchase is necessary to provide adequate emergency care. Medtronic would only be able to distribute up to 10 percent of the defibrillators it sold in 2006 to nongovernmental organizations. Sales to government agencies would not be limited.

Field corrections, routine maintenance, loaner defibrillators and replacement defibrillators or parts are allowed. Any defibrillators or component parts to meet a customer’s needs for modifications that comply with American Heart Association guidelines or comparable international standards are allowed. The firm also may conduct limited upgrades to its LifeNet systems for use with LifePak 12 models.

“During the last year, we’ve made significant investments and improvements to our quality systems, and we are pleased to have a plan that formalizes the path to resume full distribution,” Brian Webster, president of Physio-Control, said.