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I am a 24 year old woman who has been battling chronic back and neck pain for the past six years. I am writing this blog to help others and to educate others about Peripheral Nerve Field Stimulation (PNFS) which is a new application for Neuromodulation technology that treats pain. My trial PNFS implant is scheduled for Monday, July 6th, 2009 and the final surgery is scheduled for Tuesday, July 21st, 2009. I will be documenting my journey through the process. _____________________________________

Saturday, July 11, 2009

It's Not FDA Approved??

Sorry for the delay in writing...

So two days ago I made an appointment to meet one of my Saint Jude Medical reps for some adjustments to my stimulator (I have two, Alicia and Jennifer). Jennifer called me the day after surgery and she had indicated that there are many different parameters that they are able to adjust with their computers that I am unable to adjust on my unit. Alicia is my clinical specialist rep who met me at the surgeon's office to do the adjustments. I cannot rave about Alicia and Jennifer enough. They are both really awesome at what they do. Plus I LOVE their jobs. So maybe when I get well they can put in a good word for an interview. ;) Ok ok. So back to the point. I sat down with Alicia and she hooked up an HP handheld device to my stimulator. She then began to tweak my current programs by adjusting the frequency, which is a measure of how many electrical pulses per second. At a higher frequency the stimulation feels like a more constant buzzing. At a lower frequency its a slower pulsating feeling like a boom-boom-boom. After toying with a few programs I realized that my preference is a lower frequency of about 30, whereas my previous programs went up to 90. She created 3 lower frequency programs for me and one additional one that was the same frequency, just at a higher strength (in case I became to used to the others). I am very happy with the programs now and I am getting great relief, except for in my left shoulder where I think the lead isn't place deep enough under the skin.

I also learned a lot of really great information from Alicia about my procedure. Numero uno being the fact that field stimulation for the trunk, which is what I have, is not actually FDA approved yet. Peripheral Nerve Field Stimulation actually refers to stimulation of the limbs. I am not sure how I was approved for the surgery since FDA approval trials have not even been scheduled yet. Oh well. All I know is that I am lucky enough to try it and hopefully it will become FDA approved so more chronic pain patients like my self can benefit from such amazing technology. I am pretty pleased at this point. I am not saying I am exactly looking forward to the final surgery, but I will look forward to the results.

2 comments:

  1. My stimulator is an occipital nerve stimulator...it's in my head to control headaches. It's not FDA approved either but I too hope it soon will be. I'm also very glad that my insurance decided to cover it, but they have covered other things for me that were not FDA approved either, such as Botox injections. Luckily FDA Approval and insurance coverage do not go hand-in-hand or else I think there would be even MORE people out there suffering unneccessarily.

    I'm glad to hear the new programming is working better for you. I also prefer mine to be set at a lower frequency...it seems to give me better relief and less irritation for some reason. I'm actually surprised at that...I would have thought the pulsating sensation would be more irritating than the buzzing sensation but it's not...at least not most of the time!

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  2. That is interesting that insurance coverage and fda approval do not go hand in hand. I am suprised by thst. I do know that Saint Jude Medical is unable to provide any literature or promote do to the fact that there is no fda approval. I had botox injections too but I thought they were fda approved. I agree. I would have thought that the lower would not be as comfortable.

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