A reported 11 out of 400 of St. Jude Medical's ($STJ) Brio deep-brain stimulation devices to treat Parkinson's disease have malfunctioned. Doctors were also forced to remove 8 of the implants outright and replace them. Why? They stopped working after bodily fluids penetrated the tiny equipment.
As MassDevice reports, St. Jude responded by pulling the device from the market for two to three months so it can fix the problem. Brio isn't sold in the U.S. but has been available in the European Union since 2009 and is also sold elsewhere internationally. Brio is rechargeable, about 10 mm thick and about 1 ounce in weight, according to the company.
Leerink Swann analyst Rick Wise first highlighted the problem, according to the story, citing a letter the company sent to physicians. The company recommends that European customers instead use its Libra system, Wise is quoted as saying, which obtained a CE Mark in 2009.
"As part of our ongoing commitment to patient safety and product quality, we are taking a proactive approach and implementing product improvements," a St. Jude spokesperson told FierceMedicalDevices by email. The spokesperson emphasized that Brio's temporary market withdrawal will affect the European, Australian and Latin American markets.
If there's good news, it is this: Wise said the company doesn't expect much impact from the temporary market withdrawal for its fiscal 2012 first quarter or full year guidance. (Selling 400 devices in two-plus years isn't a large amount.) Brio is part of St. Jude's neuromodulation division, which booked $419 million in sales in 2011, according to the company, up 10% compared with 2010.
- here's the MassDevice story
Editor's Note: This story has been updated to include a comment from a spokesperson from St. Jude.