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Medtronic Class 1 Recall on Interthecal Pumps

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Posted 3/26/2008 8:05 AM (GMT 0)
Anyone with a Medtronic Pump might want to check the FDA recall website. Yesterday, the FDA issued a Class I recall on recently implanted pumps.  This is the most serious type of recall and patients with pumps should be familiar with the warning signs.
Posted 3/27/2008 4:14 PM (GMT 0)
Hi Stella!!

It's always great to hear from you...even if it's a recall. Thanks so much for taking the time to post this. I'm sure you'll save others from misery.

Give that puppy a scratch behind the ears for me, ok???

Chutzie
Posted 3/27/2008 4:22 PM (GMT 0)
I have a medtronic device, but not a pump, what a pump. I have a pacemaker in my sacral nerves for severe IC.
Posted 7/3/2008 7:42 AM (GMT 0)
I have a medtronics pump that has been recalled. I found out Tuesday 7/01/08 when my pain doc told me he is no longer filling pumps. I went on the medtronics site to find a new doctor when I saw the recall. I was furious. Then I read that anyone with dilaudid that has a concentration greater than 10Mg/ml is at a severe risk of forming granulomas on the tip of the catheter. My concentration is at 70mg/ml. My doctor had always told me that there was NO Danger in my concentration level.To make matter worse, when my pump was last refilled I should have only had 1ml left. I had 10ml left and the pump was telling the computer it was empty. I have a 40ml pump that lasts about 4 months or 10ml per month. The last 3 weeks before the refill I began to have a increase in pain and with drawl symptoms and no one took me serious. Now I need a new doctor, pump, and maybe Major spinal Surgery. Any advise would be greatly appreciated.
Posted 7/3/2008 12:26 PM (GMT 0)
Stella Marie,

Thanks for posting this update. I hope all goes well with you.

Fieldgoal,

I really feel what you are going through. I hope you are able to find a new doctor soon and one that is sympathetic to your situation! It is rough facing withdrawl symptoms and not having medical professionals address that for you. I just want to say, don't give up. You will find someone soon that will help you and get you back on track.

As for the pending surgery, I don't know quite what to say, except take one step at a time. First the doctor, then the evaluation, then the withdrawl address, then talk about future surgery. You will get there. Again my heart goes out to you.

Please keep posting and let us know how you are doing. You might want to start an additional thread that is more specific to you. By the way, welcome to the forum. I'm glad you are here!

Wishing you the best hon,

Lindaloo
Posted 7/3/2008 3:49 PM (GMT 0)
Fieldgoal my pump is also on recall. But, I am not having any trouble with mine either, so for the time being we are leaving mine alone. The pumps have been on recall from the gears not working correctly and thats what it sounds like you are going thru. Contact Medtronic again, they will pay up to $1,000 for any out of pocket expenses you incur having the pump taken out and a new one put in. I am very much aware of all the letters as I subscribe to he FDA site. Good luck, Susie
Posted 7/3/2008 4:13 PM (GMT 0)
Fieldgoal, I'd be furious with my doc if I were you! I'd probably think of filing some sort of suit against him. I'm sure he knew about the recall which is why he wouldn't refill it for you and I'm sure he has the obligation as a medical professional to notify all patients of these kinds of recalls as soon as he becomes aware of them. He's risking your health by not saying anything and refusing to take you seriously about your withdrawl symptoms and other problems. I'd have the pump removed or replaced if it was working and get a new doc ASAP.

Best wishes to everyone who is part of the recall. And thanks Stella for informing us about this.
Posted 7/3/2008 4:27 PM (GMT 0)
Fieldgoal, I forgot also you are right about the about the concentration levels. Medtronic has had an increase of people having masses at the tip of the catheter from what I have read. Medtronic sent letters out to drs telling them about this problem and they advided the drs to use the lowet dose possible to keep the pain under control. So i effect, there are 2 recalls from Medtronic, one for the gears not working properly and then the mass problem that has cropped up. Susie
Posted 7/3/2008 4:45 PM (GMT 0)
I don't know anything about the pumps except what I'm reading from all of you, but I'd be scared, angry and looking for both a doc and a lawyer!

PaLady
Posted 7/4/2008 1:39 AM (GMT 0)
Thank you all for your replies and concern. I have spent the last 36 hours on the phone with medtronics. Yesterday they told me to go to my PCP and have him call your local medtronics rep and she would advise him on the severity of intrathecal with drawl and that she would meet me in the hospital so she could run some Non-Invasive tests to determine the pump problems and the possible remedies. When my PCP spoke to her on the phone, all she told my PCP was to tell me to find another doctor. needless to say there is another doctor in a 30 mile radius, but he is on vacation, then he would need to reed through my charts and medical history, then he would see me for a consultation, and finally then if he approves me I can make another appointment to have him check my pump. So basically i wouldn't get my pump looked at for at least 6 weeks. I understand the responsibility that a new pain doctor has, and that the consults are necessary. But that means 6 weeks of with drawl, pain etc. I don't want to & can't afford 6 weeks in the hospital to get pain meds. I am only 31 and I am having high blood pressure, fast pulse, and in need of some spinal treatment at the least.I have no insurance and I am in the middle of applying for SSDI. So I am paying everything out of pocket for now. Hope to hear from you.
Kevin

dx- 16 rt. knee surgeries, 2 left knee, MRSA Infection in rt. leg,
RSD in rt. leg and lower back, 4 herniated disc's
Rx- dilaudid pump, fentora 800mcg, ativian, cymbalta, nexium
Posted 7/6/2008 4:22 AM (GMT 0)
Hi Fieldgoal!

I missed your first posts but I'd like to welcome you to Healing Well and to our CP family! I am so very sorry about the awful position you're in right now. There are a couple of possibilities for some help.

First call your Local Red Cross. Yep...don't need a tornado or earthquake to get help from them. Anyone in need gets help. They even hook people up with health insurance many times. Then...for the costs you're are paying out of pocket...call Medtronic and/or the people who make the medication you use in the pump. Many of them have supplemental or free programs for those without insurance. Also, below are a couple of web sites that often will help with getting medications. I sure hope something breaks your way soon. Hang in there...we'll do whatever we can!

Hugs,
Chutzie

http://www.themedicineprogram.com/
http://needymeds.com/
Posted 7/7/2008 10:26 AM (GMT 0)
thanks for the websites and for making me feel welcome on this site
Posted 7/9/2008 9:02 AM (GMT 0)
Fieldgoal,
I've been debating the pump for about seven months. Thanks for the information.
My doctor LOVES to implant those things. They scare me spitless.
Pamela Neckpain

MEDICAL INFORMATION
HYPERTENSION, SCOLIOSIS, ARTHRITIS, SPONDYLOSIS,
SPINAL STENOSIS THROUGHOUT THE SPINE,PINCHED NERVES C5-C7, NEUROPATHY THROUGHOUT THE SPINE, ANXIETY DISORDER, DEPRESSION, CONSTIPATION, POSSIBLE KIDNEY STONES (OR CANCER) DEGENERATIVE DISC DISEASE C3-C7

MEDICATION
MONOPRIL, HYDROCHLOROTHIAZIDE, METHADONE 10 MG. 3 BY MOUTH 3 TIMES DAILY. XANAX 1 1/2 MG. 3 TIMES DAILY, NEURONTIN 600 MG, 4 TIMES DAILY, FOLBEE TABS, SENOKOT S , 5 TABS AT NIGHT.
Posted 7/9/2008 7:13 PM (GMT 0)
Fieldgoal whats the odds of your PCP giving you pain meds to help with the W/D problems. I mean, he knows the pump is on the skid and common sense is you will need medication until the problems is resolved. I do think once I got securely in with another pain dr, I would file a complaint with the the state medical board of the idiot dr. I went for a refill yesterday and talked to my dr about the masses being reported on the tips, he says its drs uneducated in pumps. The drs are not educated in what meds to use in the pump is the big problem and having peeps on too high doses. In 24 hr period I am receing less than 3 1/2mg of medication. My concentration level of Dilaudid was increased to 15mg quite some time ago. As long as I don't lift, sit too long or take a fall, I get along well considering it all. I rarely have to take BT meds at all. I find my muscle relaxer does the trick much better. Pumps do work and I am one that is proof of it. I hope they get you taken care of quick. Could the PCP call the new dr & explain your situation to speed things up? Sometimes all it takes is a dr to dr call. Hang in there, Hugs coming your way. Susie
Posted 7/10/2008 7:41 AM (GMT 0)
My PCP is very aware of the situation and that I just got an apt. with a new doc on Tuesday. The question is, Why should I sit a home and suffer till Tuesday. The PCP is very trusting and he know most of his opioid meds from me or by my recommendation. He know that I was given dilaudid 8mg 1 per 4 hrs. That dose isn't even in the same strastophere as intrathecal

dilaudid. When dilaudid is at 10mg/ml 1 mg of the intrathecal dilaudid is equal to 300mg of oral dilaudid. I'm at 70mg/ml and 27mg per day. I also have been off the fentora which I was taking 540 of the 800mcg per month. 1 every 90min. I used  up my free quanity till 7/14. So I am going to ask my PCP put me in the hospital on fentora or actiq and see if that helps. Also the drug rep. has now agreed to meet me $ my PCP in the hospital to begin the different diagnostic checks so when I see the new doc, he has the most up to date info. But that only if the PCP will admit me for pump , withdrawal and skull evere bone pain

Posted 7/10/2008 5:22 PM (GMT 0)
Oh man, you are in my prayers. You must have help and now. Please pleaselets hope your PCP will go laong with this. You should have to suffer like this because of that idiot you had for a paindoc. I do ask that if you get put in the hospital, please take a moment to just post and say you are going in. Good luck, Susie
Posted 7/10/2008 7:11 PM (GMT 0)
I hope everything goes well for you and that you can get all this taken care of ASAP. I hate to hear your suffering because of doctor error. Yes please keep us informed on how you are doing if you can.
Posted 7/11/2008 4:36 PM (GMT 0)
Hi Stella Marie,

After reading your post I became very worried. As of yet I haven't been to the FDA website but I wanted to ask a question about what you said about pumps that have been implanted recently. What is considered recent? I have had my pump for nearly two and a half years and am now at last at a level in my pump of

11 (?) dose of diaudid everyday. I also have found that finally after 2 and half years I have gotten to a

point where I am finally getting relief and have started to become active and up and about after nearly

15 years of being bed ridden. Needless to say I am over joyed by this change in my pain level. So my question is if 2 and a half years is recent, as you said in your post? I would hate to think that after finally reaching a tolerable pain level that allows me to begin living again that my pump is one of the recalled pumps.

Any help with this would be truly appreciated.

Good luck to you and I am sorry you are having so many problems, also I agree with everyone else that say you should definitely find a dr. because it is just inhumane to think that you have to go through the

with-drawls and pain that I am sure accompanies it.

Thanks for listening and I will be calling my dr. asap and going to the web site you talked about.

 

Toritoo

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Posted 7/12/2008 3:24 AM (GMT 0)

Toritoo, you can call Medtronic and they will run your serial numbers and product number to see if your pump is on the recall for the gears not working properly. My pump is on the recall but I am having no problems with it. Therefore, my dr & I both say leave it alone. One way the drs know if the pump is functionly correctly is when you go for refills they measure the medication pulled out of your pump. There should be a certain in the resevoir. If you have too much or too little remaining then you have a problems going on, also your alarm will go off. Also, if you have an increase in pain for no specific reason and you are experiencing withdrawal symptoms. I did talk to Medtronic about the recall and there has been some pumps that the gears have slipped, it does not mean all pumps will do that, there is a small amount this has happened to. Even if one pump fails they have to notify the FDA.

The FDA site is much better to get info from than Medtronic I found as far as alerts being posted. The masses that are being reported are from incorrect medications being used in the pumps, too high of doses of medications which is a result of uneducated drs when it comes to pump patients. You can get granulomas if you took a daily high dose of oral Morphine, and there are other meds as well that will cause this as well. Calm down, because none of this may affect you at all. If you are doing well without any problems then obviously your pump is working correctly like mine is. Hugs Susie 

Posted 7/12/2008 3:32 PM (GMT 0)
Dear Susie,
Thanks for answering my questions and like you at the time I don't seem to be having any problem with my pump even though I know it is at a high level, daily and the concentration of the dilaudid they use to fill it has just been increased
again. I will call Medtronic and find out what it is I should be worried about or if I need to be concerned with this. I also
plan on talking to my dr. the next time I see her (in about 2 weeks). Your reply has put my mind at ease for the moment and I thank you for that. I just had my pump refilled and the amount she removed before refilling was right on, according to her. I must say it seemed like quite a bit to me but I will wait and see. Thanks again Susie, I hope you have a good day, (weekend). Hugs from here as well.
Toritoo

And one more thing, I haven't been around for awhile so I just want to say hi to everyone and I hope you all have a
less pain day/weekend. Hugs to all
Posted 7/12/2008 7:43 PM (GMT 0)

Toritoo, believe me when I read about the gear problem, man I was on the phone to my dr and spoke to his pump nurse. She had me email the info to her which of course I did. My next phone call was to Medtronic and for once I got a a nice informative person on the phone. She ran my numbers for me with no problem. Now, you understand any time a pump fails, its at your expense not Medtronics, to have the pump taken out and  replaced, did you know that? All Medtronic pumps are sent back to them when a patient has one removed. On this recall Medtronic has their people check the pump out to see if its defective or not. If the pump is defective and another pump is being implanted then, Medtronic will give up to $1,000 to cover your out of pocket expenses. Not much to compensate a person for in my book. 

Truly you need to contact them and give them the info off of your card so they can run the numbers. Your pump may not even be involved. That way when you see your dr you can tell her you contacted Medtronic and they ran your info and if your pump is one of the models then you will have accurate info at the time of the appt. From what I understand back in January they sent letters to peoples drs with pumps telling them of the potential problem with the gears. It was the 2nd alert I read and my dr said they were not sent any letter but Medtronic said they did. What my dr was aware of is the granuloma problem that has been cropping up. He has not had any patients have a problem with their meds causing trouble in the pump, and the only pump they replaced was one a man had for 11 yrs.  They are not suppose to last near that long. But, my dr is very educated in the pumps so I have confidence in him. He said it was my decision on taking out this pump and putting a new one in, then Medtronic could then test it for the gear problem. I honestly believe that my pump is fine and I don't have that fear like I did at first. Not all the pumps are having the gear problem, so its not like all of them are bad. You can go into the archives at the FDA site and find the info.

I am with you, when they take the old meds out it seems like alot but they tell me its what should be left in there. If you have too little or too much in there then ya got a problem. I have been right on the money since June of 05. Try nnot to worry because I really think your is ok like mine. Please let us know what your has to say. Hugs, Susie

Posted 7/12/2008 11:43 PM (GMT 0)
Dear Susie,
Thanks again. I'm really not that worried about my pump and your letter has put my mind more at ease. I don't quite understand what you were saying about them taking it out and sending it back to them to see if the gears are alright, in the meantime are you left pumpless until they find out if it's ok or if you need a new one? I'm sure that is not an option
I'm interested in. I would imagine I would have to be hospitalized in the time between removal and finding out if I need
a new one. Sorry to bother you with this and you have been very kind in answering my letter with so much information already, so I hope you don't mind me asking again. Thanks ever so much Susie so have a good weekend. As pain free
as you can!
Toritoo
Posted 7/13/2008 9:19 PM (GMT 0)
Toritoo, no they would implant a new pump, you would not be left pumpless. Sorry, I was not clear on that one. If the old pump was in the group of recalls then after receiving your old pump Medtronic would have their people test it to see if it was failing. If it turned out to be a problem pump, Medtronic would reimburse you up to $1,000 for your out of pocket expenses.

Like I said, mine is working fine and we say leave it alone. This pump has been my life saver for sure. Susie
Posted 7/14/2008 3:12 AM (GMT 0)
Thanks again Susie, much like you I finally feel like the pump is going to be my life saver as well. It's still early in my getting any good results from it but at least now I have felt that painfree feeling again after so very long and I don't want any thing else to get in the way of the rest of my life.

Mine is fine for now and I will still look into it and hope like you that I'm ok. Enjoy your painfree or your less pain days Susie,
like I am. Many thanks again.

Toritoo
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