The story diverges at that point, however. That's because she's not talking about a Medtronic implantable cardiac defibrillator (ICD) with defective Sprint Fidelis leads that are known to be subject to fracturing and have been recalled; she's talking about a Medtronic InterStim II implantable bladder pacemaker that's supposed to help control bladder problems such as chronic incontinence.
The InterStim II received fast-track supplemental approval from the federal Food and Drug Administration (FDA) in July 2006 as an upgrade to the earlier InterStim. Among the modifications noted in FDA's approval announcement was... thinner leads. Sound familiar?
Kraft (not her real name pending possible legal action) had an InterStim II implanted in November 2007. The device uses four thin leads that stimulate the sacral nerve to help with bladder control. The frequency of stimulation can be controlled via a range of different programmable patterns. Kraft, who works as a delivery driver for DHL Courier, says, "I've had a bad habit of wetting my pants," hence the InterStim II. She hoped that it would solve the problem.
In mid-January 2008, Kraft went in to her doctor to have the device checked. At that time, she says, she was told that the main lead was not working. "One month after my surgery and my main lead is already not working," she says. "They said it might be because it was in a fluid pocket, whatever the heck that is, and it's no big deal." A month later, she says, "I went in again and they said it was fractured and had to be removed and replaced.
"They said the lead was cracked, possibly from a pressure point. I'm a skinny lady and I drive and bend a lot, so they're thinking that between those two things, that's why it broke. Now they're saying that even if they do fix it, there's no guarantee that it'll work again. Meanwhile they billed my insurance company $45,000 for this thing and I didn't get two months' use out of it. I'm getting help from the state, which is helping me out through Medicaid because I was so far behind in my bills that they picked me up. I'm maxed out with my regular insurance. They only cover so much a year.
"This doctor's big on this thing; she implants them every week on Thursday, all day long. She's put in like a hundred of them. She said that another girl just had a problem with hers, and she's a school bus driver. But my god, bending and sitting is an everyday thing in any job—just bending and sitting!
"They knew all about my job and my size before they even went forward with this. Normally, you go in on Thursday and you can be back at work on Monday, but they kept me out of work for four weeks because of my job; she wanted to play it safe before I went back to work. I had to take four weeks of no pay at work, too. They don't give you unemployment if you're not available for work. I couldn't get workers' compensation either, since it wasn't a work-related issue.
"Before you have the system put in, a Medtronic rep explains everything to you, but once it's in it's just you and the doctors; the Medtronic rep disappears. I called Medtronic and said I wasn't happy about it. I asked who was going to pay for taking it out.
"They say it's not up to them, it's a medical problem and they'll bill it to my insurance. By the time this is all done, I could be out $100,000 or more. Nobody's really guided me about what to do. If it's a bad system, I just want it taken out. I'm a 48-year-old woman and I can't afford to be missing work.
"Now it's more or less non-functional. I called the Medtronic lady because nobody was getting back to me about whether to fix it, keep it in, or take it out. My dad said to turn it off, but she said to go ahead and keep using it, but the leads need to be replaced. They say the batteries are supposed to last three years, but God knows if that means I'll have to be cut open every year and have a new battery put in.
"In the meantime, I'm walking around with this dead thing in me and my doctor says, 'Well, if we fix it and it breaks again, we'll know it's your job.' Am I supposed to change jobs because of this? Well, I live in Michigan and there are no other jobs. Believe me, I've looked.
READ MORE LEGAL NEWS
"I've contacted my doctor and asked for an itemized bill so I can see how much this whole system costs. It's a real money maker for them. All my doctor does from 7:30 AM to 7:30 PM every Thursday is whip these things in. Medtronic isn't going to let it out that there are troubles with this thing and it's not as great as they're making it out to be. Meanwhile it's my body and this thing's bumping around inside me.
"Maybe somebody knows something and knows where to direct me. I'm just that kind of a person—I don't like to get screwed over."
READER COMMENTS
Stephanie Moore
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Sarah Fulton
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Marielie Vasquez
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Linda316
on
Taryth
on
So far I'm still peeing every 45 minutes and my bladder doesn't feel empty right away. I'm also waking up soaked (I pee the bed) and last night I peed the bed 3 times!
The settings cause me pain except 2, I have 6 settings, 3 on the left and 3 on the right.
I'm praying that this will work but it's disappointing me right now.
Lenoah callahan
on
Christine Koning
on
All was good for 15 months...Now I suffering severe hip pain a long the sight where the wire runs, I can barely walk. Its back to the doctor I go to start this long journey of pain, time of work and waiting game as he tries to figure out what is going on. I was never warned of any of the complications I have experienced. Not once as anyone from Medtronics followed up with to see how if things are ok in 9 years.. Maybe to time to consult a lawyer.
Brenda Marquez
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Carolyn Lytle
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R. Gordon
on
Has there been any new advancements to help those with incontinence? Medications, procedures etc?
Pamela Jordan
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Kaye Kelley
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Bruce Hackett
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Brittiany smith
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Christine Nesheim
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If anyone knows of a good lawyer or case against this device please let me know. Thank You
Carolyn Barnhill
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What a nightmare! Put in in july of 2013 and demanded it be remived in December of 2014.
I had a bladder infection nearly every 15 days and was put on antibiotics and am now allergic to several antibiotics. The antibiotics screwed my immune system leading me to contract hashimottos disease!
The device surfaced to the top a month after placement so another surgery to bury it deeper only to have it flip over. Then another surgery to right it. In the meantime and several settings with no success, the device shut off or the interen shut it off--who knows but went for a couple of months with it not working. Medtronics rep was very mad. Got it working again only to have it surface back to top and then flip again and begin shocking me even when I wad asleep!
Had to just turn it off. Then dr suggested taking it out and trying it on the left side. I said just take it out, it was not working for me. I was then informed it was a $30,000 device. I should respect it and let it work!
I demanded it out and said it was causing the bladder infections but was told that was not possible.
Had it removed and guess what--it was massively infected so they had to take it out and would not have been able to move it to the left side. Hmm--a year and a half if total pain, tears and frustration!!!!
Latasha Morgan
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jerry Harrison
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Pauline musgrove
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Rhonda Maddux
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Kim Womack
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anne
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Linda
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My stem is once again sticking out (still under skin but can see it & feel it)!!! Feels like my insides are falling out!! And now on top of it..........it feels like a bladder infection!! Sex is also an issue. I have had a hysterectomy so I should not bleed. Wonder if we will get any relief or help from someone before we can't get out of bed from the pain.
I pray for all of us to receive the help we need!,
Donna Pease
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Mike Bidwell
on
I have had my current implant for awhile now with a lot of success. However I'm still having knee issues. For the last month my lower back has been in tremendous amounts of pain. I have been seeing a chiropractor and a spinal doctor and neither can figure out what is causing the pain since I can't do an MRI. The x-rays have been causing them to scratch their heads. The pain is getting worse so I'm hoping that during my next check up with my urologist some answers can be given or at least direction on what to do. I'm 37 years old now and got the implant when I was 26 so I got it fairly young and am hoping I have not gotten any permanent damage.
Janet
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Melinda
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Sherry
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Jenn Claus
on
Very recently I have started having falling spells, an increase in my hemiplegic migraines, systolic BP issue's only, fever's and myclonic jerking in my left arm along with vision problem's, which my vision I've never really had an issue with as well as my BP. Today (18th) I finally was able to get into see my surgeon/urologist and after diagnostic testing they discovered my implant to not be functioning correctly. They couldn't get it up to 1 without me being in severe pain in area's I shouldn't have felt it. For over 6 month's it's been a non stop recommendation of turning my new implant off for a long period of time and then turning it back on, etc. Another thing that I have noticed since the original one was placed was non cancerous tumors occurring which I've had to have removed due to their locations, I have had to have one removed from the back of my right arm which turned out to be fat nacrosis (premature dying of fat cell's)...one removed from the bursa sack of my left knee, one from my abdominal wall (last year), one from my right anterior part of my shin (we're now their is a more dense tumor in its place). I also have a non cancerous tumor in my left breast that is not small and a small tumor to the right of my lower lumbar vertebrae.
My hemiplegic migraines (neurological migraines) have gotten more frequent to the point they have caused me to have sensory overload (ringing in my ear's, taste and smell disruption, visual impairment, balance issue's, memory loss where I'm forgetting day's/time/etc.)
Since shutting the implant off I am no longer experiencing a sporadic shock that starts in my hip and travels into my groin and makes me stumble. However, I'm experiencing pain around the implant and to the right of my lower vertebrae close to it. I was also informed today that I am safe to get an MRI on my head as long as it does not go below the neck because of the neurologist are wanting to see if their's more going on with these rare migraines. I was always told to never have an MRI due to the magnetic affect on the battery so I'm a bit confused by this.
It is up in the air if the implant caused my fall's which led to the implant not functioning or the fall's led to the implant not functioning.
I have always had sporadic perephial nerve issue's with my left arm but I have noticed an increase in that as well. As well as my sleep has been extremely difficult because it feels like I am unable to shut off my brain processes.
I am seeing a neurologist at the same hospital where my urologist is located and my urologist at this time wants to focus on what's happening and occurring in my head, however, she did inform me I would have to undergo another procedure to fix the problem which can only be performed under general anastasia since I fall into a rare category where I do not respond to conscious sedation at all.
As I informed their office today, when it work's, it's a miracle, however, it has been rough since 2013. I am fortunate to be dual covered to cover the costs, however, I am working towards the goal of getting off social security after graduating from college last year with my Bachelorette degree in Criminal Justice and with a 3.47 GPA. This issue has unfortunately taken me away from my master's degree program because of the severity. Last July, I suffered from a spontaneous right leg swelling that started from my right knee down into my foot and it took me having to go on a water pill just to bring down the swelling. Also prior to all the fall's I had my implant set at 1.3-2 without any form's of discomfort now my urology specialist office can't even get it to 1 without me being in pain. I have never suffered from my ear's ringing until December of last year. As I had mentioned I just turned 35 this past February and I'm very concerned. I suffer from Raynauds disease (circulation disorder) as well in my leg's and feet that is now starting to affect my hand's more. My dr/surgeon say's it's a simple fix but if the neuro issue's are a result of the implant is this permanent??? If it is permanent, do I have to worry about it getting worse???
I have always been proactive in my health ever since my accident that killed my best friend's mom. The last thing I want is for my almost 15 year old daughter to loose her mom due to complications related from the interstem. Has anyone else experienced any of the symptoms I've discribed???
Phyllis Stein
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sharon kilburn
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K J Ellis
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Milly G
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Amberlee Snook
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Has this happened to anyone else, if so any advice?
PLEASE HELP!
essie osborne
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Nancy
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Scott McKay
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RestoreSensor Model 37714 Medtronic Neurostimulation System that is
surgically implanted in my lower back 4/4/2012.
I have had 3 painful surgies to correct extreme pain caused by the
electrodes after the Medtronic Neurostimulation System LEADS broke.
This seems to be a regular problem that Medtronic's
has always known about but I was never told of these problems.
I have had a lower back fusion in 2007 and back pain since than, so the
Medtronic Neurostimulation System seemed to be an excellent choice.
The Medtronic Neurostimulation System did work great as to relive me of my
back pain and mostly to take less pain medicines such as Percocet 10/325.
This is now a major setback I feel that now has False promises, in that
Medtronic knows of these electrodes and leads causing major problems.
I BELIEVE my problem is not just the broken leads that a recent X-Ray
showed, but the main stimulation system itself failed and now sends an out
of control shock and pain impulse that I was not told could happen.
June 27th 2013 the Medtronic Neurostimulation System broke inside me to
where it shocked me painfully and uncontrollable until I struggled to reach
my remote control to turn it off. If I was not home at this time to reach
the remote control this would have been a torturous pain that I could not
have stopped until the device was turned off.
The Medtronic Neurostimulation System will now need to be surgically removed
permanently as I never want to be in this painful situation again.
I am disabled on Medicare at age 49 since 2008 from Colon Cancer and back
problems and cannot afford to have this painful operation.
I now feel that I have been taken advantage of for there own experiment as
to how these leads break.I had my Doctor remove the Medtronic implant Tuesday the Oct 15th 2013.
I believe these leads where moving around in me freely as much
as 6 inches or more from where they were originally placed, X rays would
show the severe pain this movement was causing me. The pain I am in at this
time has me wondering how well the surgery went. Did the doctor cut me too
much to take out the broken wires he was removing? I should mention here
that Dr. T is not a surgeon. However, thats the least of my concerns
right now.As I mentioned, I have had and am still having major pain and suffering from
this implant and realize that this company was just using me. I saw a
segment on Good Morning America, Monday the 14th about how it can or can
not help you. Also I feel Medtronic representatives had no concern for me
and never offered any help or solutions which was very upsetting to me.
When I was in the waiting room the 15th, the Medtronic Rep walked into the
Doctors office and I had to address him. He would have just passed me by if
I hadn't addressed him. And he KNOWS me! After that initial greeting I
never saw the rep again. I presume he was there only to collect the
mechanism, which I felt I was entitled to keep in my possession.( I asked
for the mechanism and was told that I could not have it.) When I had the
operation, did I BUY the mechanism or did I just RENT it? Considering the
mechanism cost $20,000, I think I have a right to know! The fact that the
Medtronic people showed no concern and made me feel like a worthless Guinea
Pig leaves me with a feeling of hopelessness and helplessness as to my
future and quality of life. I still do not have the funds or know how to pay for this operation. Doctor
T and I agreed that there would be no cost to me as I told him I could
not pay anything at anytime for this. He did cancel the initial bill for
$3,500. I would like to pursue this matter because I feel very strongly
that, in addition to helping me, other people should know what this company
is doing. No one else should ever have to go through the pain and suffering
that I have. The lack of concern and the riskiness of the machinery alone,
is enough, but the insufferable pain endured is unforgivable.
I am pleading with you to help in this cause.
Jan Franklin
on
discussed with me what strenghts I should stay with in....well after 2 weeks I went back to work, my job is physical, bending lifing, in & out of vehicle 60 or more times a day. I began to go downhill with my recovery, when I move or rub area certain way I feel this shocking screaming pain, brings tears to my eyes in the incision area, then I get really sore in the area where the leads were implanted, I hurt in the center of my spine and my right hip after I am up on my legs for several hrs...so I filed FMLA for more time off hoping more rest will alevate & heal pain, but im beginning to wonder after reading other posts...let me be clear it certainly has helped w my urgency problem, but has caused other the issues I am now dealing with.. if anyone out there has advice please respond...
Jan Franklin
on
discussed with me what strenghts I should stay with in....well after 2 weeks I went back to work, my job is physical, bending lifing, in & out of vehicle 60 or more times a day. I began to go downhill with my recovery, when I move or rub area certain way I feel this shocking screaming pain, brings tears to my eyes in the incision area, then I get really sore in the area where the leads were implanted, I hurt in the center of my spine and my right hip after I am up on my legs for several hrs...so I filed FMLA for more time off hoping more rest will alevate & heal pain, but im beginning to wonder after reading other posts...let me be clear it certainly has helped w my urgency problem, but has caused other the issues I am now dealing with.. if anyone out there has advice please respond...
denise ashburn
on
april
on
Marilynn
on
Rena
on
Rena
on
Yvonne Borelli
on
D. Wilson
on
Deborah Martinez
on
Or email mr at dmartinez1170@gmail.com
Thanks for any help!
Alice Sanders
on
So, they put in a smaller device, but the lead wires are right at the bottom of my spine. I hurt all of the time, and already had degenerative disc disease, so this really hurt my pain. I thought possibly a new battery would aleviate my bladder problem. No one believes someone goes to the restroom 70 times a day...and night. So instead of changing the battery, they put in an entirely new device as mentioned above. Well it didn't work at all. I have this device in me that doesn't work, and the doctor and the Medtronic Representative are telling me it is because the wires need changing.
So I go in to have the wires changed and they put in another Medtronic Interstim....and then tell me they couldn't change the wires, they had to put an entirely new device, the same model number and everything. Well here I am still going to restroom 50-70 times a day and night, so I went to see two more urologist. The first one referred me to another one in his office that put Interstims in and takes them out. The third urologist tells me I need to go back to the urologist who put it in and have it taken out, he is having nothing to do with it.
So I go to a fourth urologist, they do x-rays and cannot find the lead wires, and I am in horrific pain all the time running to the restroom every few minutes. Since 2005, I have been a prisoner in my own home. Even if the Interstim is taken out, I am still going to have the same problem. The PA in the office turned it completely off because she could not figure out why it was shocking me.
TAMMIE
on
Mandi
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Ginny Moore
on
At the hospital I was told the device was "coming out", that was the hard plastic thing I was feeling. They transferred me to the hospital where it was put in and my urologist removed it the next day.
Following the removal of the estim, I spent a week in the hospital and SIX WEEKS in a nursing home to keep the sight packed so it could heal properly. The wound I was left with was at least 9 inches deep and it took about 9 weeks to heal completely. This has been a horrible experience and my doctor and his staff had lied to me over and over again. I was told that infections were "rare". Something that is rare is not plastered all over the Internet. I think this kind of crap is criminal. I was so sick I thought I was dying. The infection was so persistent, I was sick for months with it. And I kept telling my doctor and the ER doctors I wanted it removed. Not until it tried to come out on its own would my doctor even talk about removing it.
I cannot believe there is no class action lawsuit over this. It certainly seems like there should be. I'm now looking for another urologist because I no longer trust the one I had. It's a bad deal all the way around.
Kim dwelt slater
on
Kristine Krebsbach
on
Rachel
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Paulette Rasberry
on
Penny
on
takashia j
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kathlene sims
on
Dianne Richardson
on
Thank you
Dianne Richardson
on
Thank you
Connie Sperandeo
on
The removal surgery is scheduled for April 30,2014.
I agree with the class action lawsuit. We should do it .
Missy
on
Maybe evyone on this site should form a class action suit against Medtronic. If anyone wants my advise do not allow your doctor to implant a Medtronic devise.
Thomas Niel Murphy Jr.
on
Tonya Michelle Murphy
on
I have briefly read through a few of these. I have conducted so much research on this thing because my mother passed away right after surgery. She was last seen approx. 1:30 in the afternoon then found dead the following morning.
I knew there would be a day people would have questions. I have done some extensive research.
I feel horrible because I promised my mother I would not let anything happen to her. She was so worried. I called her doctor in which the nurse called back and claim it to be a very simple procedure and that I was not needed. I told my mom this and it was as if she won the lotto. I have kept everything and continue to research. If anyone needs anything or has questions I will help the best I can. I am no expert but till this day. Medtronics has been known to pay kickbacks. I too think there should be a lawsuit and to get this device off the market completely. I have heard more negative things about this than good plus my mother is dead. I have not felt the same since nut to help or so a class action would be an inspire that I so much need. It still feels like yesterday. Not a day goes by that I don't think about her. My e-mail is N2AngelCare@yahoo.com and my name is Tonya.
Christy Climer
on
Maurine McPike
on
Cathy
on
Thank you,
Cathy
Cathy
on
Thank you,
Cathy
Shatavia
on
denise ashburn
on
denise ashburn
on
mj
on
Unfortunately, I have been having problems with the device which seem to be getting worse. At first, I noticed that I was feeling the stimulation in odd places (on the outside of the crotch area, not the lower inner labia as in the test, or in my rectum) and that I was continuing to have bladder accidents.
The urologist turned the device up to the point that it is mildly painful and told me to "try to tolerate it." After that, I seemed to not urinate much for several weeks and also became extremely constipated (which laxatives failed to resolve).
It appears that I now may have an impacted bowel and my bladder problems are worse (possibly in part due to the increased constipation). Today, I have had at least 8 accidents, two of which went thru the Depends and flowed onto the chair and the floor. I am now feeling the stimulation mostly in the rectum.
I called the urologist's office and they don't seem to be interested in trying to adjust the device further or remove it for me, but now want to inject Botox into the bladder to treat what they believe is overactive bladder.
However, I have done the Interstim procedure (despite my own qualms) based on their advice, and don't feel that doing another extreme treatment without really figuring out what is causing the problem and trying safer alternatives is a good idea.
As for the Interstim, I am not sure if it would work if the urologist were willing to spend the time to trouble-shoot it more with me, or if a wire slipped out of position after the surgery somehow, or what, but I would most likely NOT have the Interstim procedure again.
It really seems that my bladder and bowel problems are now worse. Perhaps the higher level of stimulation was too much, and my worsened symptoms are the "backlash" from the device inhibiting normal functions too much.
MJ
willie marable.jr
on
Sarah Parker
on
S D
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Sarah Parker
on
Christopher Lee
on
I arrived at the hospital an hour early(6a.m.) was checked in and than called back to a room. Right before the surgery Doc comes in and says cant do implant insurance wants another test. The forst one was in office but they put me under for a deeper test implant I guess. First few days were great. Urinary retention was down to almost nil and bowels had slowed to 2 to 3 times a day, again my miracle medtronic. The friday a week following my surgery I awoke to stiffness and pain in my tailbone. I have dealt with a lot of pain so I tried to just tough it out. By 8:30 that evening I could not get up off of the couch I was crying and had my son bring phone to call for help. My mother-in-law Helped me to the ER where they asked if I wanted a wheelchair I stated no because of the pain caused by the sitting or standing and I knew I would not be able to get out of the wheelchair. Finally got to a room and my mother-in-law helped me onto the bed. I laid there facedown unable to move from the excruciating pain. They did CT, labs, low grade fever of 100...etc... but found nothing and were going to release me. My wife told the doc that I was not able to get up and had laid there face down unable to move for four hours. She than stated that someone would have to carry me to the car because she couldn't and I was in no shape to even make an attempt. The doc than called urologist on call and they admitted me for observation. I was told no infection yet they put me on a regimen of vancomycin and gertamycin via IV. I began to feel better and was ready to go home after a 2 night stay. They sent me home with pain meds and a 30 day supply of Bactrim. I am still confused about all the antibiotics with no infection present(susceptable to infections) and a history of c-diff.
I have been home now for 2 days and the pain is back with a vengeance. I can sit maybe 30 minutes before the pain is to great, laying down comfortably is all but impossible, and going from laying/sitting to standing is intolerable. I called the docs office today and they said he is not in until tomorrow which is the day before my surgery and I really need to talk to someone about this before I make this decision for a permanent implant. The results are great as having to self catheterize 3 times a day and bowels moving plus 10 times a day. However, If I can barely walk in exchange maybe not so great. Forgot to mention while in hospital doctor asked me for the Medtronic reps name and number because he wished to talk to him. I would think they would have a number but oh well. So goes my life. Another miracle down the drain after 11 surgeries, multiple infection, multiple hospital stays, etc....
You know its bad when someone would rather cath 3 times a day than deal with problems caused by the device supposed to fix them. Need help. Need understanding. Need direction
Sally
on
Sean Johnson
on
Gabriel
on
im from brazil and was searching for this kinds of treatments and pacemakers, but now im not that much excited with this device....
it seens a very unfunctional thing...
do you know the rate of unsuccessful improvment of it?!
thanks, answer me please...
gabrieldouran@hotmail.com
Candy
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Patsy Hoffman
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Kathi Perkins
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