Medtronic warned of violations at plant

Christopher Snowbeck

Jun. 25, 2009 (McClatchy-Tribune Regional News delivered by Newstex) -- The Food and Drug Administration has warned Fridley-based Medtronic (NYSE:MDT) Inc. of violations related to the manufacturing of drug pumps and insulin pumps at a company plant in Puerto Rico.

FDA inspected the manufacturing plant between Nov. 12 and Dec. 15, and found Medtronic failed to establish and maintain quality controls in manufacturing, according to a warning letter posted Wednesday on the federal agency's Web site.

The agency also questioned the company's record keeping, its procedures for reporting problems to the government and whether Medtronic was too slow in issuing a product recall last year.

"We've already addressed most of the issues," said Cindy Resman, a Medtronic spokeswoman. "We're committed to working with FDA to ensure that any additional actions required are put in place as quickly as possible."

In one example cited by government inspectors, multiple Synchromed II Pumps -- implantable devices used to deliver medicine to the spine -- were released for distribution and implanted in patients even though they were not filled with a needed propellant. The problem was not discovered during the manufacturing process, FDA said, even though the pumps went through a propellant weight check.

Medtronic became aware of the situation after confirming two complaints in which pumps had to be removed from patients because of a lack of propellant. The company recalled about 13,000 affected products in May 2008, but the FDA questioned why Medtronic didn't move more quickly.

"FDA is concerned with your failure to initiate a recall for devices affected by the propellant problem in a timely manner," wrote Maridalia Torres Irizarry, director of FDA's San Juan District office, in a warning letter dated June 1. "It took almost two years from when the missing propellant was initially identified to conduct a recall."

Resman, the Medtronic spokeswoman, didn't offer an explanation for the timing of the recall but said her company is always looking at how to be more responsive.

To date, Medtronic has received 11 confirmed reports of pumps without propellant, but the company doesn't expect to receive more. That's because the company changed the manufacturing process to ensure the problem is resolved in pumps manufactured since the recall, Resman said, and physicians received information on how to verify that a pump is working correctly.

She added no deaths have been reported that are linked with the problem.

In the June 1 letter, FDA also warned Medtronic about a number of other issues related to drug pumps, including an apparent failure to review, evaluate and investigate complaints of possible problems with the product.

As for insulin pumps, FDA questioned why the company didn't notify the government within 30 days of at least two reports of potentially serious patient issues with Medtronic's MiniMed Paradigm Insulin Pump. FDA specifically criticized the company for letting an employee who lacked expertise make evaluations about whether reported problems with insulin pumps could have caused or contributed to a patient's death or serious injury.

"The training record for this particular employee showed that this person only had a high school diploma with some additional in-house training," wrote Irizarry, the FDA official in Puerto Rico.

The Synchromed drug pump has been the subject of several other unrelated warning letters and recalls in recent years. None of those previous warnings was directed at the Puerto Rico facility, Resman said.

Patients with drug or insulin pumps don't need to take any new action as a result of the warning letter released Wednesday, she said.

The warnings related to the drug and insulin pumps come at a time when Medtronic faces trouble on another front: several investigations related to its spine surgery business.

Medtronic shares closed up 24 cents Wednesday, to $33.61.

Christopher Snowbeck can be reached at 651-228-5479.

Newstex ID: 35999504