Baclofen pump FAQ

[McDuff]

Damn Rdf, I thought you had yours "locked", sorry to hear ya still have probs too.

Leedogg - never heard of a long dye test either, hope it pinpoints a prob, if there is one.

I just had my pump adjusted to do big shots every 3 hrs. We didn't change dose(I'm at 860/day), just how it is delivered. We tried a 2 hr shot but it made no diff. I seem to see a diff, my legs haven't been "quite" as bad today, but this is only going on rolling in bed, been a bed squid today due to butt sore. If this 3hr strategy works, it might seem to point to maybe a micro-hole in the catheter, even though the dye test didn't show it(fast dye test). Theory being, med can leak out traveling in slow motion, but when "pushed" in faster, the med makes it past.

I have an appt. with a pump surgeon in 2 weeks, to see about getting the cath replaced.

[rdf]

Damn Rdf, I thought you had yours "locked", sorry to hear ya still have probs too.

Leedogg - never heard of a long dye test either, hope it pinpoints a prob, if there is one.

I just had my pump adjusted to do big shots every 3 hrs. We didn't change dose(I'm at 860/day), just how it is delivered. We tried a 2 hr shot but it made no diff. I seem to see a diff, my legs haven't been "quite" as bad today, but this is only going on rolling in bed, been a bed squid today due to butt sore. If this 3hr strategy works, it might seem to point to maybe a micro-hole in the catheter, even though the dye test didn't show it(fast dye test). Theory being, med can leak out traveling in slow motion, but when "pushed" in faster, the med makes it past.

I have an appt. with a pump surgeon in 2 weeks, to see about getting the cath replaced.

No, I've been screwed up since Jan 31. I was fine for two months, then got a refill, and started getting spasms, and fell out of bed. I know what the problem is, it's the catheter again, dislodged or the connector is screwed up - bouncing out of bed only made it worse, because it was 12 hours later that I was in full withdrawal.

I checked the recall, the catheter type they used is under the FDA Class 1 "informational recall." It's model 8709SC, and it's supposed to be used as one single cath, from pump to intrathecal space. But I have two links, the first link is from the original pump, 1997. So they used this 8709 and patched it into the old model 8703. I had a long talk with Medtronics and read up on the recall, and the 8709 can cause problems because it gets misaligned when connected. And it wasn't made to be part of a two-link catheter system like I have.

I told the doc to replace the whole catheter(s) when he did surgery last Dec. He said only the last piece needed replacing. I asked about recalls, he said he heard of none. The recall came out just a couple of months before my surgery, and gives specific steps and checks to avoid the problems that initiated the recall.

I am assuming that their is a problem with the connector between the old model catheter and the new one. The problems that brought forth the recall was connector damage, or the catheter port would get sucked into the connector seal, etc. But they're talking about the connector to the port on the pump in the recall. Medtronics said using the 8709 with the old model is feasible, and they have little kits to make connectors between the two different models. That didn't sound too good to me. I finally convinced my doctor. He's a hardass, we don't get along. I went over his head to Qaulity control to get him to listen to me. He doesn't like me, and I don't care for him, so it's not a good situation all around.

It all started when he was talking about the pump when I first met him, and he was misinformed about many things, but I kept my mouth shut. Then when I was in the ER with full on withdrawals and he wouldn't give me a bolus, only an increase of 15%, we got into an argument. The ER docs had already given me 30mg of valium via IV, three doses of 10mg, with absolutely no effect on the spasticity, before the pump doc showed up.

I ended up telling him I knew more about pumps than he did. He stormed out. 24 hours later I was still having full body spasms every half second, and the ER docs thought I was doing damage to my muscle tissue, and were worried. He came in and finally gave me a bolus and increased dosage. The bolus kicked in 7 hours later so I could drive the 100 miles home. As soon as it wore off, I'm back to constant tone and spasticity. None of the other neurologists and ER docs like him, I could tell. He's very short, and I believe he has a Napoleonic complex - he's very arrogant, won't listen to my input until I'm almost yelling at him about what I know about my body and how it relates to the pump. He's the only guy around, though, and that's 100 miles. The next closest is twice as far at the UofI, which I might end up going to if things don't get fixed this week.

But I'll get er done. Hope you can figure your problem out McD. And you too LeeDogg. If he can't find anything wrong using the dye study, which sometimes happens, I'm going to tell him to replace all the catheter, period. If he won't, then I'm having him refer me to Iowa City, where the University is. I'm wearing down and there's no reason for it except for a stubborn doctor. I can't even sit in my chair without fear of falling out, and it's been like this since last July (except for the two months after catheter surgery)

Good luck all, we'll get it figured out. Keep us updated guys.

A defective Medtronic catheter used in the company’s implantable intrathecal pain pumps has been linked to the death of one patient. In June, the company alerted doctors to the problem, but now, the Food & Drug Administration (FDA) has classified Medtronic’s catheter safety alert a Class I recall. Such a recall is defined as a situation in which there is a reasonable probability that the use of the product will cause injury or death.

Medtronic’s intrathecal drug delivery systems consist of an implantable pump and catheter that deliver small quantities of drug directly into the intrathecal space in the spine. These devices are used to treat chronic, intractable pain and for the management of severe spasticity of cerebral or spinal origin. The Medtronic catheter recall involves the following models: INDURA 1P Intrathecal Catheter, model 8709SC [ the new catheter model they put in in Dec. ], Intrathecal Catheter, model 8731SC, Sutureless Pump Connector Revision Kit, model 8578, and Intrathecal Catheter Pump Segment Revision Kit, model 8596SC.

Medtronic says it has received 83 reports of infusion system difficulties worldwide that have been attributed to either an occlusion or a disconnection of the sutureless catheter from the pump. In one case, a patient died from acute baclofen withdrawal related to complications from an improperly connected catheter.

According to Medtronic, an analysis of the products returned indicated that when there is an occlusion (misalignment during connection), the catheter port may become embedded in the inner wall of the connector seal, rather than aligning with the connector. Improper attachment can result in catheter connector damage, leaks at the connection site, or catheter disconnection some time after implant.

Occlusion or disconnection of the catheter can cause a lack of therapeutic effect, a clinically significant or fatal drug overdose or a return of underlying symptoms, and drug withdrawal symptoms. According to Medtronic’ s press release, patients receiving intrathecal baclofen therapy are at higher risk for adverse events because withdrawal from this drug can lead to a life threatening condition if not treated promptly and effectively.

Neither Medtronic’s letter to physicians in June nor the FDA’s classification Friday called on patients to have devices removed, and hospitals and doctors are not being asked to return unused products. However, patients who experience the catheter problems described in the recall will require a surgical procedure for correction, Medtronic said.

Source

[rdf]

Forgot to add, the surgeon was new at the hospital. In fact, I was one of his surgeries his first day in the new OR. He came from Missouri - and I'm sure it's hectic working with a new group of nurses and such, and maybe the recall instructions slipped by him. IF doctors and surgeons even read such things.

How much mcg is your bolus every 2 hours McD?

[McDuff]

Dayaam, guess Last I "talked" with ya was in your 2month "grace period". You definitely have a storied past with pumps. It sucks when you got a Doc who doesn't listen, sounds like you got real winner there.

My pump readout says I have catheter 8731, no SC at the end. I asked my NP about this when the recall hit, and she said that they are two different caths, so I let it drop, but will ask the surgeon again just for shits&grins.

As for bolus shots, now every 3 hours, from printout;

Basal Rate = 4.0mcg/hr

Start Time Duration Rate
00:00 00:10 h:m
1) 100.0mcg 600.0 mcg/hr

03:00 00:10
1) 100.0mcg 600.0 mcg/hr

...

21:00 00:10
1) 100.0mcg 600.0 mcg/hr

Daily Dose = 890.7mcg/day

So I went up a little this time to 890. Almost all coming in the 100mcg bolus'.

[sjean423]

I guess I need to be a little more proactive here. I just looked as well, and my catheter is 8709. No SC tho. Does the SC make a difference, or does the printout just list the numerals (the SC being understood)?

I'm not having any issues, but didn;t even realize there could be.

Guessing I have some q's for my doc!

Sorry you are back to having issues, and have a jerk for a doctor! Hope you get this resolved asap.

[bailey5774]

well update on my pump status. i went up to 295mcg and i started noticing my arms becoming weaker. i saw my rehab doctor the other day and he thinks it's because my tip of the catheter is in or around C3 or 4 i think. so they had to bump it back down to 219 and guess what my arms feel a little bit better. so guess what this means???? yup going back in and having the catheter cut down and moved down. GRRR. this wouldn't have happened if they had taken an x-ray while they were still in the OR!!! not sure what to think about this....i'll have to live with more spasms till it's fixed i guess.

[rdf]

Well it was just what I already knew. The dye study showed a huge leakage at the connector between the new and old catheters. Very little baclofen makes it up the catheter.

I have surgery on the 19th. I've told them to get rid of the two piece catheter, and put in the 8709 only, which is designed to be a one-piece catheter from the pump up to the intrathecal space.

The Medtronics rep was there, and I told him to make sure the surgeon follows the steps to verify correct connection at the pump that Medtronics has issued. I can't wait, but it's great that the problem is identified.

LeedDogg, the dye study took about 60 seconds to identify the problem. I don't know the reason your doctor wants a multi-day study done. There must be some reason, you should ask him, make sure he knows what he's doing, and has done dye studies before.

The Medtronics rep and the pump doctor of course blamed it on me. They said I was too active, being as I broke the connector that just was repaired in Dec., that surgery needed for basically the same reason, connector problems. I said BS. They asked me if I scoot around on the floor on my back, lmao. I said yeah, it's my favorite form of indoor mobilization I told them it wasn't me, it was the rinky dink setup connector kit with pins they have to use to connect the old and new catheters. The rep said no, he's seen hundreds and it's been tested and tested and tested, with no problems.

I'm just glad the relief is near. I wish everyone else good luck in solving their problems and getting some relief, also. God knows it's a great thing, this baclofen pump, but it can also be a nightmare at times. I had a good run there of 7 or 8 years with no problems, then bam, two in a row.

Good luck everyone.

[rdf]

I guess I need to be a little more proactive here. I just looked as well, and my catheter is 8709. No SC tho. Does the SC make a difference, or does the printout just list the numerals (the SC being understood)?

I'm not having any issues, but didn;t even realize there could be.

Guessing I have some q's for my doc!

Sorry you are back to having issues, and have a jerk for a doctor! Hope you get this resolved asap.

My printout only has the numbers 8709. The SC is implicit to that catheter, I was told. It means Sutureless Catheter, but doesn't show up on the printout. I'm glad I'll only be having one catheter instead of two - the more parts, the more likelihood of failure somewhere. Hopefully I can after surgery have a good run of good luck. One can hope.

[Leedogg]

what they did yesterday is put nuclear dye in my pump. and I'm going tomorrow to have a neuro xray to see where exactly the dye (bacolefen) is going and not going in my spine. The doctor turned my pump down to 290 yesterday also. Medtronics rep????? I have never once seen a rep here in South Carolina. Just docs that put them in and just "care" for them.

The doc that I'm currently seeing only adjust doses or refill units or does tests. He does not replace cathedar or put pumps in. The doc that put my pump is over two hours away. And right now they are disagreeing on if the cathedar needs to be replaced. One says yes, but the doc that put the pump in. Says try this and report back to your other doc. Even though the doc that "cares" for it has tried everything he knows. Its very frustrating.

This nuero test is the only other thing he knows to try.

Edit: rdf, I've already had two of the regular dye studies you had. And they didn't find anything.

[rdf]

what they did yesterday is put nuclear dye in my pump. and I'm going tomorrow to have a neuro xray to see where exactly the dye (bacolefen) is going and not going in my spine. The doctor turned my pump down to 290 yesterday also. Medtronics rep????? I have never once seen a rep here in South Carolina. Just docs that put them in and just "care" for them.

The doc that I'm currently seeing only adjust doses or refill units or does tests. He does not replace cathedar or put pumps in. The doc that put my pump is over two hours away. And right now they are disagreeing on if the cathedar needs to be replaced. One says yes, but the doc that put the pump in. Says try this and report back to your other doc. Even though the doc that "cares" for it has tried everything he knows. Its very frustrating.

This nuero test is the only other thing he knows to try.

My doc used a fluoroscope. It's like an x-ray, but you can see better and rotate around to get a 360 degree view. He withdrew a little baclofen, then injected the dye into the second pump port, the one not used for refills. He had cranked it up about half a minute before injecting the dye. We all sat there and watched the dye travel from my pump through the catheter. 60 seconds later the dye was bleeding out of the connector into my CSF at the base of my spine. Very little was getting pumped up the catheter to the distal end up at T7.

There should always be a Medtronics rep when any surgery is done with the pump or catheters. For a dye test, I believe my doctor brought in the rep because of all the complaining and bitching I was doing about the connector problems I'd read about. The doc doesn't like me much, but he's a little afraid after I went to the hospital's Qaulity Control when he refused to test me for catheter problems.

I could have had this done 6 weeks ago when I first went into withdrawals and told him there was a break somewhere in my catheter. He said no, it had only been 2 months since my last catheter surgery, and it had to be something else wrong with me. (He did take simple x-rays in the ER, but they didn't show any problems - which oftentimes they don't) I told him before the last surgery they'd told me I was a very healthy man, and that I didn't believe there was anything physically wrong with me that was causing the withdrawals and spasticity. I told him I felt exactly the same lying there in the ER, with full body spasms every half second, the previous 4 or 5 times in 12 years when a catheter broke or a pump battery died. He just didn't believe me, and thought I had a uti or a freakin hangnail or something similar.

Tell your doc you want a Medtronics rep there because they're trained well and might spot something your doc might miss. Or at least he can call them and get the details on how to do a fluoroscopy dye study, which is so much quicker.

Here's Medtronics number: 1-800-707-0933. Give them a call, choose tecnical support option.

Good luck LeeDogg.

[Sober Living]

best place to buy a pump?

any online vendors ?

[rybread]

It's not something you can buy, it has to be surgically implanted by someone who knows what they're doing. Do you have a spinal cord injury? With spasm problems? it wouldn't be much use to you if you don't have that.

[marmalady]

Leedogg, where in SC do you live? Who put your cath in?

[Leedogg]

i live in Johnsonville, but went to Charleston MUSC Dr. Istvan Takacs neurosurgeon (can't spell his name he's from Germany)

[Leedogg]

WOW this was a surprise today...

the pump isn't pumping at all, the dye is still sitting in the reservoir. Its not even going up the cathedar. Going back tomorrow for another nuclear x-ray to see if the dye has moved any. The doctor was not there when they did the x-ray.

If your wondering I'm not having any withdraw symptoms.