Oh, and that medical device your son has implanted in his brain? RECALLED!

My son Gee has hydrocephalus, which is an excess of fluid on the brain, and he has a shunt inserted into this brain that relieves this pressure by directing it to the abdomen. Two years ago, we were informed that the particular kind of catheter that Gee has in his brain has been recalled. I wrote about my feelings here. Basically, although they were seeing increased rates of shunt failure with this particular catheter, the risk of infection from removing it was still greater than the increased risk of failure. As long as the shunt remained functioning, removal was not recommended.

In the mail today came an update. I'm putting the actual verbiage of the letter at the bottom of this post, but the gist of the situation is that it is possibly more serious than they originally suspected. Of the 465 patients with the shunt (at Primary Children's), 26 have become disconnected. Four of the children were critically ill when they arrived at the hospital, although they don't know if that fact has anything to do with the catheter. They still are not recommending removal, but there does seem to be more risk then initially believed.

I'm not quite sure what to think about this all. Obviously, there isn't anyone to get mad at--the manufacturer and designer of the catheters never intended this to happen, and it certainly isn't the fault of the neurosurgeons. I am truly grateful for the information, and that they are keeping us in the loop.

And I'm trying not to be too worried about the situation. Shunts fail. It happens. If it happens because of the type of catheter, then we deal with that then.

But I'm struck by the little "wallet card" they included in the letter, suggesting I keep it in my wallet at all times. "Attention Emergency Physician: My child has a BioGlide Ventricular Catheter. If you see signs of shunt failure, please call xxx-xxx-xxxx IMMEDIATELY."

Super reassuring there, guys.
___________________________

Dear Parent/Patient:

We are writing today to give you further information about the Medtronic BioGlide ventricular catheter. According to our records, your child has this catheter implanted.

In March 2009, we sent you a letter because we had seen seven children with a disconnection of the BioGlide ventricular catheter. As of today, we have seen a total of 26 disconnections. A recent data analysis at the hospital showed that 50% of children with a shunt will have a shunt failure in the first 5 years. If the shunt has a BioGlide ventricular catheter, 57% will have a failure in the first 5 years.

The decision, of course, is whether we should remove the BioGlide ventricular catheters, even though your child is well and the shunt is functioning. Removing the catheter has a 5-7% risk of giving your child a shunt infection.

There is another faction in this decision. Four of the children who presented with a disconnected BioGlide catheter were critically ill when they arrived at Primary Children's Medical Center. Of course, whenever a shunt fails there is a chance of a child becoming critically ill by the time they arrive at the hospital. We don't know if the BioGlide catheter had anything to do with the children becoming critically ill.

Considering all of our data, we are not recommending removal of the BioGlide ventricular catheter if your child is well, but we do want you to watch your child carefully for symptoms of shunt failure.

As you know, if a shunt fails, a baby will usually show signs of irritability, sleepiness, or a full fontanelle. Older children will usually develop headache, nausea, sometimes vomiting and sleepiness.

If your child develops any of these symptoms, or any other problems that you are not sure about, or if you would like to discuss any of the issues in this letter, please contact the Neurosurgery Office at xxx-xxx-xxxx...

Our primary concern is your child's well being. We want to help make the best decisions for your child.