Integra's LPV II Valve shunt - Made in 2006

[Anita7]

Does anyone know anything about this shunt? I am suspecting it has latex parts (reservoir chamber) and I can’t find any documentation about it. The hospital personnel told me that the packaging didn’t have anything stating its “LATEX FREE”, like it does on the other shunt models. Integra is not giving me any information. Can someone think of anything else I can try to get this info?

[Dodger67]

Is latex ever used in any implanted devices?

[LisaJoy]

Your neurosurgeon may be able to get an answer from Integra. Also, make sure you are contacting the right division -- Integra Neurosciences. I should think they would be perfectly willing to provide you with a description of the exact components of the shunt.

You can also try contacting the FDA Medical Device division -- I tried searching various databases at www.fda.gov/ and couldn't figure out how to use them. I found the device in their approved device listing, but there should have been some record of when it was approved along with the specifications for the device submitted at the time of approval.

Their phone # is 1-800-638-2041.

Don't know how you've contacted Integra Neuroscience, but their customer service number is 1-800-654-2873.

[Anita7]

I contacted this person 4 times and he is just avoiding me which makes me even more suspicious.

Anyhow, LisaJoy you gave me another option with FDA... Thanks a bunch!

[LisaJoy]

I'll be interested to know if the FDA helps you -- be sure to report back!

[Anita7]

FDA said I can file some papers to get the documentation but, it would take a very long time. FDA’s database has no information about this medical device. I called Integra Neurosciences again and this time I got someone who said there is no latex in their shunts. I guess I’ll rule out that possibility.

[Summer25]

What would make you think it is latex? I know some of the very old shunts have latex, but the new ones usually don't.

[LisaJoy]

FDA said I can file some papers to get the documentation but, it would take a very long time. FDA’s database has no information about this medical device. I called Integra Neurosciences again and this time I got someone who said there is no latex in their shunts. I guess I’ll rule out that possibility.


That's a little scary, since the FDA supposedly has to approve all medical devices sold in the US. But at least you got an answer.

[Lifeisgood]

In general, hospitals are trying to use as little latex as possible. I would be surprised if it did have latex.