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St. Jude recall of DBS device

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#1 am0665



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Posted 01 April 2012 - 09:57 PM

Hello Dr. Okun,

As much as I wish it weren't so ... for the sake of my family member,
we just saw this as NEWS RELEASE ... TO INVESTORS !!. It didn't come from the medical team, nor from St. Jude directly to the patient. QUOTE:

St. Jude yanks Brio deep brain stimulator St. Jude Medical temporarily pulls its Brio DBS device off the European market on the "fixable" issue of bodily fluids seeping into the device… and interrupting therapy. The problem, which occurred in only 11 of the 400 Brio devices implanted so far, spurred a "Dear Doctor" letter, according to Leerink Swann analyst Rick Wise.

"There have not been any serious patient injuries reported," Wise wrote in a research note to investors today. "But about 8 patients have needed to have the device explanted and replaced due to inability to deliver the therapy … the company expects the impact from this 'recall' to be immaterial to its 1Q12 and 2012 guidance," Wise wrote. "Brio's uptake in Europe has been slow – with only 400 systems sold since the product gained CE Mark approval in September of 2009." The company expects the device to be off the market for 60-90 days, Wise wrote. In the mean time, he wrote, St. Jude is recommending that European customers opt for the Libra DBS system, which has proven to be effective against both Parkinson's and severe depression in separate studies. END QUOTE.

Now I've learned as a patient caregiver to remove the promotional sales wrapping from the biomedical "news" on the web ... I also see through bandage that covers bad news. How should a biDBS PD patient struggling now 5 months with incorrect stimulation on a Brio feel about word mongers wrapping such news into " no serious injuries reported ... immaterial to company revenue ... off the market for 60-90 days"

Whether Brio, Libra, LibraXP models, what would you advise such a patient, given several relevant threads on the NPF SUrgeon forum:

13.feb.2010 - 16.jan.2012 Post of the Week: New Study on Constant Current DBS

20.jan.2012- 3.mar.2012 http://www.mhra.gov.uk/home/groups/fsn/documents/fieldsafetynotice/con117559.pdf 24.may.2011: 78 Eon Mini IPGs and 1 Brio IPG that lost the ability to communicate or recharge

http://www.mhra.gov....e/con137890.pdf19.dec.2011: ... a short to the IPG battery can occur, leading to the failure mode...

http://www.mhra.gov....e/con137886.pdf19.dec.2011 ... During a charging session, patients may feel an increase in temperature at the IPG implant site...

http://www.bfarm.de/...deninfo_en.html 23.feb.2012: Recall of iIPGs for neurostimulation Eon Mini ... and Brio... by St. Jude Medical ...due to possible risk of recharge intervals of the battery becoming shorter or the sudden loss of power of the devices.

#2 Dr. Okun

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Posted 02 April 2012 - 06:28 AM

We will follow the information as it becomes available and let you know.

The Lancet article in Parkinson's disease used a Libra system and not a Brio system, so that is a piece of good new for PD.

Michael S. Okun, M.D.

Author of Amazon Kindle, Paperback and Audio of 10 Breakthrough Therapies for Parkinson's Disease
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips

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