FDA Issues Warning Letter to Medtronic

Federal regulators have warned Medtronic Inc. for not promptly reporting problems with some of its medical devices that may have caused serious injury or death. The Food and Drug Administration posted a warning letter to the company on its Web site Tuesday detailing problems at a Minneapolis, Minn. plant that makes drug infusion pumps and neurostimulation devices. Both products are often used to treat chronic pain and neurological disorders. During an inspection between November 2006 and January this year, FDA staff found that Medtronic did not have a system for assessing the seriousness of complaints about some of its products. Under federal law, companies are required to report problems with devices that may have caused serious injury or death. Elsewhere in the letter, inspectors write that Medtronic failed to submit some reports of problems within 30 day, as required. FDA noted that the company has already resolved some issues cited by inspectors, though the agency said it planned evaluate the company’s actions in future inspections. “We’ve implemented a new standard operating procedure for reviewing complaints in this business,” said Medtronic spokeswoman Cindy Resman. “The next step is to continue to work with FDA and we’re committed to keeping them posted on our progress.” SOURCE: Business Week