FDA warns Medtronic after drug pump plant inspection

Jun 24, 2009 (Pioneer Press - McClatchy-Tribune Information Services via COMTEX) -- MDT | Quote | Chart | News | PowerRating -- The Food and Drug Administration has warned Fridley-based Medtronic of violations related to the manufacturing of drug pumps and insulin pumps at a company facility in Puerto Rico.

FDA inspected Medtronic's manufacturing facility in Puerto Rico between Nov. 12 and Dec. 15 last year, and found -- among other things -- that the company failed to establish and maintain quality controls in manufacturing, according to a warning letter posted today on the agency's Web site.

The agency also questioned the company's record keeping, and procedures for reporting problems to the government.

"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 pain 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 due to the lack of propellant. The company recalled affected products in May 2008, but 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."

FDA also cited Medtronic for 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 leaving evaluations about whether an insulin pump problem could have caused or contributed to a patient's death or serious injury to an employee who lacked expertise.

"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.

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

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