Issues that required removal of Nevro HF10?

Hello Chris,

I hope life itself is treating you good. At this very moment I'm pretty bummed out. On March 17th, 2021 I had my SCS implant surgery done. I went through the trial period and could not believe the remarkable difference I'd noticed immediately. I suffered a work related injury to my lower back in 2014, been through two back surgeries and multiple injections over the course of the last seven years. My first surgeon (The Butcher) installed a cage on my lower spine, apparently did not know what she was doing and caused me severe nerve damage in my left leg. I suffered from 2016 (first surgery) until I was approved for my second surgery in 2019 where my new surgeon installed a bigger cage which eliminated SOME lower back pain but I still suffered with the burning and nagging aching in my left leg. I was referred to another PM doctor who told me about the SCS and I agreed to do the trial period. It was a success. The next day after the trial surgery I noticed a significant difference in my left leg. So I was all for the final implant which took place on 3/17/21. Now as I sit here replying to you because I cannot sleep due to my nerves (mentally) being shot, I'll be on my way to the hospital in just a couple of hours to have the implant removed. I've had it in me for three weeks as of yesterday and have had intense drainage from the incision just above my left buttocks where the device is. I have been on the strongest of the strong antibiotics since 3/30/21 and cannot seem to get the severe infection under control. My doctor says that my body is/has rejected it. I saw him yesterday and he decided that we must have an emergency surgery immediately. I have been crying non stop since he told me the device needed to come out yesterday at my appointment. My doctor is worried that I could end up with Meningitis due to the infection travelling up the leads into the spinal fluid. I'm heartbroken! Aside from the incision pain and the pain from this horrible and severe infection, I have had the best three weeks of NO pain and have NOT had the constant, nagging aching from my lower, left buttocks that travelled all the way down to my toes. I honestly feel like a four year old child who just went to the biggest candy store, got the biggest lolly pop, took five licks and had my lolly pop taken away from me. I was told that if I wanted to let my body heal up 100% that we could try again over the summer. Due to the severity of this infection I have decided to opt out and not go for a second try at it. My favorite cliche is; "It is what it is!" At least I can say I tried but it just was not meant for me. I wish you all the best and hope you have the opportunity to have the chance of living a pain free life.

With kind regards,

Angel

I just saw a Dr to start process for trial of Hf10. I had back surgery last year, been through injections, physical therapy and all kinds of tests.

I am researching the stimulator and patient reviews. So glad to see you all on here. Not glad to see others in pain though. What restrictions are there if you have the permanent procedure? We did

didnt even go over that.

This a response for the HF10 stimulator.

When my pain management doctor suggested this device, telling me they would put a test device out side of the body with the leads going into my back to see if would help.

The temp device was installed. I was ecstatic I got about a 40 percent of pain reduction. Finally I was going to get some relief and to get some of my life back.

So the permanent device was installed. I immediately had problems it burned when charging. They told me it should stay charged for about 3 days not so. The relief was hardly measurable. They reprogrammed the device. It at least felt like it was starting to show some function but the burning when charging was intensifying.

Quick note this is about Oklahoma personal. When I kept telling them about the problems they told I didn't know what I was talking about. I ask about maybe I got a bad device. Their response was they don't have bad devices.

Things just got worse. It started taking longer to charge as long as 1.5 hours which got worse. The device just kept getting hotter every charge attempt. It finally got to the point it would not charge or when you finally got it to say it was charged it would show a short time latter that it hadn't charged if at all. If any at all. Even the representative had problems connecting to it.

When he was able to connect to it he kept telling me I hadn't charged it in two weeks or sometimes longer. I said that is what I had been complaining about. With the charging issues and it getting so hot when it tried to charge that it was unbearable.

They just kept telling me I didn't know what I was talking about. To the point they would not answer my calls anymore. I have this device in my back for 3 years now that it has never worked correctly or was helpful and the staff would not listen to me.

You might get proper support in another state and representatives that at least will listen to you. I truly feel that I have a defective device and if it had been replaced I would have the results that the trial version results it had gave me.

Here in Oklahoma they are only concerned about their numbers. My pain management doctor no longer recommends this product since all representative visits was in his office and knew of the results.

I get no response from HF10.. With my results and experience I would not recommend this device. Their website only post responses that they want you to see and post no others. They control what you see or hear.

sorry to hear of your condition.I have just been told i need a stimulator as well .Like you i take pain meds had 7 surgeries and last was a 4 level fusion(never would i ever have this done again made me 10 times worse than i was was.i find it very confusing as there is a multitude of stimulators out there and i cant find any info on success or failures only propaganda to sell there own.

i hope someone can put something up for us to read or links to sites where we can get the information we require

Hello,

I am 47. I started having rare occurrences of low back pain and neck pain in high school and it slowly progressed over the years and became a major part of my life. It affected every area of my life until I was no longer living, just existing and barely even that. I did epidural injections, rhizotomies, chiropractic care, massage, acupuncture, many pain medication adjustments (oral, topical, injections), braces, and too many rounds of PT to keep track of.

I had my spinal stimulator placed June of 2019. It worked pretty good for the first 5-6 months. Then the problems started. My charge times slowly increased until I was charging twice a day for 2-3 hours each time. My pain relief got worse. The nevro rep hooked me up and said I had an area of impedance (damage in the insulation on the wire at one of the sites) and this causes leakage of some of the "stimulation" outside the wire. This causes the battery to work harder, drain quicker and take longer to charge. The rep reprogrammed the stimulator to bypass this area. Each time the stimulator is reprogrammed I have to start all over with trying to find a setting that gives me some pain relief. I am on cycle number 4 of starting over because of more and more areas of impedance.

I am now at the point where the nevro rep is saying he has "never seen this before". He thinks I got a lemon generator or the leads were damaged some how. So now they are recommending a replacement of the leads and if that does not work a replacement of the generator. I have been messing with it for just over 2 years and am not sure I want to go this route again. Plus the surgery was quite painful. My whole back hurt because I had one lead tunneled to the cervical area and one to the lumbar area as I have chronic pain in both areas. The oral pain meds they gave me made me vomit which increased the surgical pain immensely.

I am requesting to speak with a neurosurgeon as well. I want all my options before making a decision. I just want to be able to function. If I had not had so many issues with impedance I would have wholeheartedly recommended the Nevro HF10 implant because when it worked my pain was more often at a bearable level. I went from calling in to work 1-2 days a week, every week, to 8 weeks of no call ins. Then the impedance problems started and I could feel myself sliding back to where I had been. Here is where I am.

I actually discovered this site in my research to find out if my experience is a rarity or if it is more common than they are leading me to believe. If more people have had this experience it will definitely affect my decision on whether I will replace the nevro HF10 or if I will go with neurosurgery.

I was told the implant and leads are MRI safe. Just an FYI, that I don't remember ever being told, they are not MRI safe if there is impedance. If there is damage to the insulation on the lead the MRI can cause the lead to heat up and burn your spinal cord.

There are lifting restrictions for about 6 months to allow the leads to heal in place. They also did not recommend chiropractic adjustments or massages for that time as well. I do have scars that are visible on my back from the surgery. The pocket where the actual generator was placed is only visibly noticeable due to the scar but the generator can be palpated. I usually keep my controller with me as I have had to have some unexpected abdominal surgeries that required the stimulator to shut off because they were using a cautery during surgery.

Just my experience, not sure if it is helpful.

Karen

I am sorry you are going though this. I am going to try this HF10. and now I have read all the things that all of you have been going though I am haven 2nd thoughts about doing this.

i am glad to see i am not the only one to have the issues of bumps in the middle of the back. i moved to a different state almost a year ago and trying to get the rep in new state to meet with me has been a nightmare . my programming has not even been completed. now the unit isn't functioning correctly, and with the issues of the pain from the battery pack and the leads in the middle of my back, it can go away i havent been able to use it in almost 6 mos and suffer from it and still suffer daily from excruciating pain.

for anyone considering it really think long and hard as it isnt your saving grace even if you are told otherwise