Guidant Recalls 50,000 Defibrillators

June 18, 2005

Cardiology, Technology

After almost three years of having an implantable cardioverter defibrillator (ICD) installed in my chest, I’ve come to the point where I don’t think very much about this thing. But that has not always been the case.

During the first few months after installation, I had some horrible problems. My defibrillator (a Medtronic unit) misfired seven or eight times. In my case, the situation was the result of problems with the leads that connect to the inside wall of my heart’s right ventricle. Apparently, the leads were misreading my heart rate. Indeed, the complete system thought that my heart was beating at twice the rate that it actually was.

Now that’s not nomrally a big deal. The unit was set to deliver a shock when my heart rate exceeded two hundred beats per minute (BPM). Since the normal heart beats between seventy and one hundred BPM, you wouldn’t expect big problems. But I exercise regularly. And I love to get my heart rate up. It is very usual for me to dirve my heart rate to 140-150 BPM.

Well, when I went on my first bicycle ride after my surgery, I did fine – until I hit the first major hill. My heart raced to provide blood needed by my body. And my ICD misread my heart rate. I received seven “therapies” (euphamism for 300V shock). And these things hurt like heck.

Well, I had to have my ICD replaced. And it is one thing to replace a faulty car battery. It is quite another thing to replace a defibrillator. While the surgery is routine for a cardiologist, it is anything but routine for the patient. You must be put to sleep so the doctor can open a small incision in your chest. This incision allows the doctor to build a “pocket” for your new “friend.” And then leads are threaded into arteries that lead into your heart. BTW, your heart must be stopped when this is done. The leads are then attached to the inner walls of your heart.

While the surgery went quite well, the recovery was quite a different story. Having been a QA analyst for a major telecommunications firm, I know what nagging flaws are. And I have seen problems that you thought were resolved reoccur unexpectedly. So I lost confidence in my device, my doctor and myself. I didn’t want to let my heart rate increase over 100 BPM. I just wanted to make sure that this thing never misfired again.

So a routine surgery to fix a minor technical problem resulted in some major mistrust. I didn’t exert myself at all. And let me tell you, when you are afraid of something like this, your fear makes you question EVERY activity you do. So my life went from normal to very strange in a very short period of time. If you ask my kids what it was like to walk with me, they’ll tell you that I shuffled along like an eighty year-old man with palsy.

It took me almost eight months before I started to trust the machine in my chest. Once I regained that trust, I got back to a more normal life. I ride fifteen miles every day. I do anything and everything that I did before the original ICD implant. And as I noted before, I have gotten to the point that I almost forget this thing.

So when I read the ABC News headline that 50,000 Guidant ICD’s have been recalled, I had three reactions. First, I sighed with releif because I don’t have a Guidant device. Second, I began to wonder if other manufacturers (like Medtronic) had unreported problems of their own. Finally, my spirit is aching for those who have to go through a re-implanatation.

In my case, device malfunctions follwwed by a re-implantation resulted in severe mistrust (i.e., fear) for a very long time. I pray that this does not happen to other patients. If you are reading this and you have a Guidant ICD, trust your cardiologist to determine whether or not you need the replacement. Then trust your cardiologist to perform a successful surgery. And trust the new device to perform as it should. While problems can occur, you have to remember that the device is in your chest for a reason. Without the device, you could be in real danger.

And don’t let my story scare you. If you have an ICD, know that these devices are rigorously tested. And with any health-related device, the tests are conducted by many different groups. Indeed, I would expect the manufacturer to be taking a “better safe than sorry” approach. Of course, I would make sure that _all_ surgery costs are covered by Guidant – not you!

And if you are really stressed over this, drop me an email @ cyclingroo@gmail.com. I would be glad to correspond with you. For many of us, we were given a second chance. So let’s not squander that chance with fear, uncertainty and doubt. In God’s holy Word, we are told that God is not the author of fear. Rather, fear is the realm of the adversary. II Tim 1:7 says “For God has not given us a spirit of fear, but of power, and of love, and of a sound mind.” Hosea 4:6 says “My people are destroyed for lack of knowledge.” Therefore, rest in knowledge, not fear.

So learn about the recall and get to work with your care professionals. If you are interested in more information about the recall, check out the following:

Guidant’s site and comments

-CyclingRoo-

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One Comment on “Guidant Recalls 50,000 Defibrillators”

  1. Kamron Says:

    What an awesome way to explain this-now I know everhtynig!

    Reply

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