Implanted pumps made by Medtronic Inc. (MDT:US) to deliver painkillers and drugs may corrode and fail, said U.S. regulators who requested a meeting to discuss the issue.
The Food and Drug Administration letter stems from an inspection at the neuromodulation unit for Minneapolis-based Medtronic that concluded May 9 and found corrosion in the SynchroMed II pump can cause the motor to stall or seize.
While the failure was identified in October 2007, Medtronic, the world’s biggest maker of heart-rhythm devices, doesn’t yet have a plan to prevent future recurrences, the agency said in its letter. There have been 567 complaints from corrosion, according to the FDA.
“There is no one else in the market with this product, and it has considerable benefit to patients,” Chief Executive Officer Omar Ishrak said by telephone. “The FDA is interested in understanding the details and what our plans are, and the opportunity to present this information to them is a good one.”
Medtronic fell less than 1 percent to $41.14 at the close in New York. The company reported first-quarter earnings of 85 cents a share today that matched analyst estimates and reiterated its fiscal 2013 profit forecast (MDT:US) of $3.62 to $3.70 a share.
The plan Medtronic proposed to monitor and evaluate complaints with its products in the future is adequate, the agency said in the July 17 letter.
The regulator requested an independent outside review to confirm the company is handling reports of device malfunction properly after its earlier efforts failed to document withdrawal symptoms, increasing pain levels and other problems with the devices, the agency said.
Last year, Medtronic recalled the SynchroMed II and warned doctors the pump batteries may fail. A failure can lead to sudden loss of therapy, the return of symptoms or drug withdrawal, which in some cases can be fatal, the company said. The company has since received approval for a new battery and the device continues to be sold.
Medtronic confirmed the potential for corrosion in the pump motor and is working to resolve the issue, Donna Marquard, a company spokeswoman, said in a telephone interview. The device remains reliable and is performing as well or better than expected, she said.
“We remain confident in the SynchroMed II pump and its ability to delivery safe and effective therapy for people who need it,” Marquard said.
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