FDA enters consent decree with Medtronic RE IT Pumps

[Phyzicz]

Only a few hours old...
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm444690.htm

"The legal action requires the company to stop manufacturing, designing and distributing new Synchromed II Implantable Infusion Pump Systems except in very limited cases, such as when a physician determines that the Synchromed II Implantable Infusion Pump System is medically necessary for a patient’s treatment."

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[drrosenrosen]

Found this out on a day that I have two pump replacements and a new pump implant scheduled. I canceled the implant, pending learning more about this situation. But I feel that, if a company is willing to submit to invasive government oversight, it's only because the alternative was much worse. Told the patient I canceled that, basically, I'm not going to start patients on a therapy that is under investigation by the FDA.

Planning on doing a lot fewer pumps in my new practice (CA only), but I'm going to be talking to the Flowonics rep. Has anybody worked with them?

 

[emd123]

Interesting...To be continued.

 

[MedZeppelin]

I too, find the whole idea of signing a consent decree somewhat alarming. My legal advisor indicated this could indeed put the physician at increased "risk". I will most likely pause pump implants until this is cleared up. Anyone else have more information about the specifics???

 

[Stim4me]

I too, find the whole idea of signing a consent decree somewhat alarming. My legal advisor indicated this could indeed put the physician at increased "risk". I will most likely pause pump implants until this is cleared up. Anyone else have more information about the specifics???

The medtronic response to physicians tends to minimize the decree.. Medtronic totally neglects the "very limited " clinical indications to implant their synch 2 pumps.

 

[synchrotruth]

Everyone interested in Medtronic Synchromed range of pumps please check this Youtube video titled “The Synchromed Pump. How the deaths, pain, and suffering would have been prevented?”. This video allows you, the viewer, to made aware of the horrifying discovery that as early as 1998, Medtronic had already known about the numerous dangerous risk events and side effects which have since resulted in the many deaths, injuries, and health complications associated with the use of its range of Synchromed Infusion Pumps.


Video :

 

[BobBarker]

Couldn’t make it through one minute with the robot voice. Go the local college’s drama department and find someone to narrate this for $100.

 

[lobelsteve]

Must be robo hater. Clearly searching sdn then posting same video.

 

[Orin]

Yeah, I was wondering if they had a new consent decree since the old one had been lifted!

 

[Ducttape]

what i really love is that there were only 34 views, and no comments either way. clearly they are trying to drum up interest in something that noone cares about.

 

[Mister Mxyzptlk]

resurrecting this thread to see if anyone is using Flowonics. In the interim there have been problems there as well, like dying during an MRI.

 

[Orin]

I am actively avoiding their devices due to the MRI issues. They have a good product but until they kill/revise all their 1st gen non-MRI compatible hardware, and ideally synchronize with Medtronic for an interrogation system, I cannot recommend them. The risk of a radiology tech accidentally using them and not realizing it needs to be emptied prior to an MRI makes me not want to use them at all, but I like options.