Medtronic, the world's biggest maker of devices that help maintain a normal heartbeat, failed to correct manufacturing problems and investigate...
Medtronic, 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 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 yesterday on its Web site, after February and March inspections of Medtronic’s Redmond 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 the company recalled in February.
Medtronic’s cardiac-rhythm-management business, which also includes pacemakers and implantable defibrillators, accounted for 46 percent of the company’s $2.78 billion in sales in the quarter ended April 29.
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“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 yesterday. 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 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.
The Redmond facility is the successor to Physio-Control, the local company that first commercialized the defibrillator. Manufacturing was shut down for a year beginning May 1992 after an FDA inspection raised questions about quality-control procedures.
At the time, the plant was a unit of Eli Lilly.
Shares of Medtronic fell 44 cents, or 0.8 percent, to $52.40 at yesterday’s close.
Seattle Times staff provided the history of the Redmond facility.