Medtronic Inc., the world's biggest maker of devices that help maintain a normal heartbeat, failed to correct manufacturing problems and investigate complaints about its LifePak 12 external defibrillators, U.S. regulators said.
Medtronic Inc., the world’s biggest maker of devices that help maintain a normal heartbeat, failed to correct manufacturing problems and investigate complaints about its LifePak 12 external defibrillators, U.S. regulators said.
The U.S. Food and Drug Administration in a June 9 letter cited damaged cable connectors and failures to follow through with preventive action. The agency posted the letter to the Minneapolis- based company today on its Web site, after February and March inspections of Medtronic’s Redmond, Washington, plant.
Medtronic’s LifePak 12 external defibrillators, used in hospitals to shock the heart back to a normal rhythm, are similar to the 1,924 LifePak 500 devices that the company recalled in February. Medtronic’s cardiac rhythm management business, which also includes pacemakers and implantable defibrillators, accounted for 46 percent of its $2.78 billion in sales in the quarter ended April 29.
“We have been working with the FDA for several months on these issues and believe we are close to getting this resolved,” Medtronic spokesman Rob Clark said today in a telephone interview. The company will meet with agency officials later this week to present an update, he said.
About 60,000 LifePak 12 external defibrillators are in use worldwide, Clark said. The company in May 2004 upgraded the connector cables on about 35,000 of the devices that were already sold and in service, he said.
In the warning letter, the FDA said Medtronic also didn’t investigate some complaints about defibrillator malfunctions, including one involving a patient’s death. Problems were linked to broken or bent pins in the cable connectors, possibly because the company didn’t have adequate inspection procedures, the agency said. Failure to correct the problems may result in legal and civil penalties, the FDA said.
Shares of Medtronic fell 54 cents, or 1 percent, to $52.30 as of 1:22 p.m. in New York Stock Exchange composite trading. Before today, they had risen 6.4 percent this year.