want information on why doctors have decided to discontinue implant of medtronic pain pump

woman Community Member May 19, 2008
  • Hi:  I have a Medtronic pain pump (Type 2).  I think the model 3647II.  Recently my doctor told me casually that no one is treating or implanting the pump anymore as "it has not been very effective.)  I was flabbergasted!!  I have never been able to tolerate the pump very well because I get sick if the dosage goes very high.  I am on .174 Dilaudid and 1.74 Bupivicaine.  I want to know why doctors have stopped using them. I already know that the Medtronic company sent out an urgent warning as of January 2008 about this particular pump causing an increasing number of granulomas but there must be more to it if docs have actually stopped working with it and will not even take patients who have it.  I live in a big city but according to my doctor only one other doctor will take someone with a pump as a patient.  I should have been told about this sooner and there must be more to it.  Please let me know anything you think would be helpful.

     

    thanks a million.

18 Comments
  • Karen Lee Richards
    Health Guide
    May. 24, 2008

    This is the first I've heard that doctors are refusing to take patients with the pain pump, however, given the seriousness of the FDA recall, I can understand their hesitation.  The FDA has classified the Medtronic pain pump as a Class 1 recall.  According to the FDA, "Class 1 recalls are the most serious type of recall and involve situations in which...

    RHMLucky777

    Read More

    This is the first I've heard that doctors are refusing to take patients with the pain pump, however, given the seriousness of the FDA recall, I can understand their hesitation.  The FDA has classified the Medtronic pain pump as a Class 1 recall.  According to the FDA, "Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death." 

     

    If you go to the FDA's Web site http://www.fda.gov and do a search on Medtronic pump, you will find links to all of the Medtronic recalls, warnings, adverse event reports, etc. 

     

    To get some idea of how widespread the issue of doctors not wanting to treat pain pump patients is, I would suggest going to our ChronicPainConnection forum and posting your question in the thread "Willing to share experience with intrathecal morphine pump implant"  under General Discussion.  The gentleman who started the thread, Bob Englebardt, is usually up on all the latest information regarding pain pumps.  He and other forum members can tell you how doctors are handling this issue where they live. 

     

    (If you haven't been to the forum yet, you'll have to register seperately from your SharePost registration, but you can use the same e-mail address and password so it's easier to remember.)

     

    Karen

    • Anonymous
      TT
      Jun. 12, 2008

      I got my Medtronic Pain Pump put in around 2004 and in Nov. of 2007 my pump quit. Medtronic people told me that I was the 2nd person in eleven yrs. that they have ever had a pump quit.  No reason why but it was removed and replaced.  I had just finished the new study of Praialt that is a new pain pump drug.  I was serverly disabled after a broken...

      RHMLucky777

      Read More

      I got my Medtronic Pain Pump put in around 2004 and in Nov. of 2007 my pump quit. Medtronic people told me that I was the 2nd person in eleven yrs. that they have ever had a pump quit.  No reason why but it was removed and replaced.  I had just finished the new study of Praialt that is a new pain pump drug.  I was serverly disabled after a broken back and neck.  I am walking some but still on oral meds.  I was paralyzed and in a wheelchair in 2000.  I travel 2 hrs away to fill and maintain my pump.  I thought mainly due to the fact that I live in a small town and for one I don't really trust the Dr.s here.  I am also using fentanyl as well in my pump.  I was allergic to morphine and dialoted worked mildly.  I am on a slow raise again after the first pump finally getting up there and starting to do a good job, then failure and had to start all over again.  I am doing so so now but recently found that he scare tissue is wrapping around my spinal cord and pinching my ciatic nerve.  I am in a great deal of pain currently and still using the pump but on a low dose and working up again to a good dose.  I have what they call the peanut pump but hold the largest amount of meds.  The Dr. I go to is one of the for front Dr.s and travels around helping and teaching other Dr.s about it.  He is Dr. Timothy Deer in Charleston, WV @ St. Francis Pain Clinic.  NO-One has ever told or mentioned a recall to me, even to date or at the  time of failure.  I can say prior to the failure it was a heaven sent and was helping me walk and try to enjoy life somewhat more than ever since 2000.  

    • Anonymous
      Anonymous
      Dec. 21, 2009

      I think Dr. Deer is now using another programmable pump - Prometra by InSet.  I've heard that it's more accurate than the Synchromed and may not be subject to the problems of the recalled Medtronic device.  Something to ask him about anyway...

    • Anonymous
      jennifer
      Sep. 14, 2013

      i too have had Medtronic Synchromed 2 pumps since 2004..I have had Dillaudid and marcaine, which is Lignocaine(local anaesthetic) Every 3 years my pump has stopped  and I have had to undergo surgery to replace it, after 5 pumps the last in February this year 2013, I was told by the Medtronics Rep that there are only two drugs approved by Medtronics.  They...

      RHMLucky777

      Read More

      i too have had Medtronic Synchromed 2 pumps since 2004..I have had Dillaudid and marcaine, which is Lignocaine(local anaesthetic) Every 3 years my pump has stopped  and I have had to undergo surgery to replace it, after 5 pumps the last in February this year 2013, I was told by the Medtronics Rep that there are only two drugs approved by Medtronics.  They are Morphine and Baclofen, which is used for spasticity.  They took my pump away to find out why it had stopped and apparently the Dillaudid Crystalizes inside the motor and Jams it so it stops.  So this is what has been happening every 3 years, instead of my pump lasting the 6 to 8 years it is supposed to..  They then put Morphine in my pump,and I ended up in hospital for a total of 48 days, due to severe very painful headaches in both my temples, they were giving me morphine injections every three hours and they were doing nothing. Then they thought I might have a thing called Temple Arteritis, so they did a Biopsy on the left side of my head, but this showed up clear,  they then decided that I may be allerig to Morphine in the pump, which is weird as I've had Morphine for the 23 years I've had my ChronicPain. They then put the Dillaudid back in for a short time until they could work out what to do next,but that retained 9 kilos of fluid in my legs and had to be taken out.  They then put Su-Fentanyl into the pump but it also did nothing and blew my body up especially my legs with Fluid Retention.  For the last 4 months I have had Pethedine in and it also is doing nothing,as I am in more pain than I have been since having the pump put in in 2004.  My legs below the knees are so painful, I have been having it turned up every three days, with no relief. Now my pump doctor has said that she doesn't know what to do anymore, so she is giving me the flick and I am being referred to another Pump Specialist, who hopefully has alot more experience..  For Medtronics to say that they have only had 1 pump fail in 11 years is rubbish.  Many people with Dillaudid in their pumps have them stop and jam up, they cannot be restarted once it crystalizes inside the motor..  Good Luck Jennifer  Australis..

       

    • Anonymous
      jennifer
      Sep. 14, 2013

      i too have had Medtronic Synchromed 2 pumps since 2004..I have had Dillaudid and marcaine, which is Lignocaine(local anaesthetic) Every 3 years my pump has stopped  and I have had to undergo surgery to replace it, after 5 pumps the last in February this year 2013, I was told by the Medtronics Rep that there are only two drugs approved by Medtronics.  They...

      RHMLucky777

      Read More

      i too have had Medtronic Synchromed 2 pumps since 2004..I have had Dillaudid and marcaine, which is Lignocaine(local anaesthetic) Every 3 years my pump has stopped  and I have had to undergo surgery to replace it, after 5 pumps the last in February this year 2013, I was told by the Medtronics Rep that there are only two drugs approved by Medtronics.  They are Morphine and Baclofen, which is used for spasticity.  They took my pump away to find out why it had stopped and apparently the Dillaudid Crystalizes inside the motor and Jams it so it stops.  So this is what has been happening every 3 years, instead of my pump lasting the 6 to 8 years it is supposed to..  They then put Morphine in my pump,and I ended up in hospital for a total of 48 days, due to severe very painful headaches in both my temples, they were giving me morphine injections every three hours and they were doing nothing. Then they thought I might have a thing called Temple Arteritis, so they did a Biopsy on the left side of my head, but this showed up clear,  they then decided that I may be allerig to Morphine in the pump, which is weird as I've had Morphine for the 23 years I've had my ChronicPain. They then put the Dillaudid back in for a short time until they could work out what to do next,but that retained 9 kilos of fluid in my legs and had to be taken out.  They then put Su-Fentanyl into the pump but it also did nothing and blew my body up especially my legs with Fluid Retention.  For the last 4 months I have had Pethedine in and it also is doing nothing,as I am in more pain than I have been since having the pump put in in 2004.  My legs below the knees are so painful, I have been having it turned up every three days, with no relief. Now my pump doctor has said that she doesn't know what to do anymore, so she is giving me the flick and I am being referred to another Pump Specialist, who hopefully has alot more experience..  For Medtronics to say that they have only had 1 pump fail in 11 years is rubbish.  Many people with Dillaudid in their pumps have them stop and jam up, they cannot be restarted once it crystalizes inside the motor..  Good Luck Jennifer  Australis..

       

  • Lynn
    Jul. 19, 2010

    I just moved to the Charleston, SC area and I am trying to find a doctor in a 50 mile radius that will service an existing pump, as well as fill it each month(that is the schedule that in place in  the one  that I had put in  Phoenix) All the pain mangement doctors I called all said they do not SERVICE ones already in. I really...

    RHMLucky777

    Read More

    I just moved to the Charleston, SC area and I am trying to find a doctor in a 50 mile radius that will service an existing pump, as well as fill it each month(that is the schedule that in place in  the one  that I had put in  Phoenix) All the pain mangement doctors I called all said they do not SERVICE ones already in. I really don't want to keep traveling back and forth to Phoenix, nor do I want to have this one removed or have a new one installed if I can help it. But, If that is what it takes to keep one in my back, so be it. So, if someone knows a doctor in the area that do them, please contact me @ (480) 560-3467 Thank you in advance and God bless.         

    • r hagen
      Feb. 03, 2011

      i also have had no luck with doctors to take care of my pump but i have basic homel infusion  Basic HI.com  1-888-822-7428 that come to my home and refill my pump.they also say they can help find doctors

  • Anonymous
    loving the pump
    Jul. 19, 2010

    Hi, I have had the Medtronic pain pump implanted in my back for the last 3 years. I  LOVE IT !!! It is the best thing that has come along in a very long time. I have not had any problems with it except in the beginning when it was first implanted. The doctor and I had a hard time find a happy schedluing for the pump. After about a couple of months,...

    RHMLucky777

    Read More

    Hi, I have had the Medtronic pain pump implanted in my back for the last 3 years. I  LOVE IT !!! It is the best thing that has come along in a very long time. I have not had any problems with it except in the beginning when it was first implanted. The doctor and I had a hard time find a happy schedluing for the pump. After about a couple of months, Bingo!! Don't get me wrong there have a couple of times that we went up, we went down, and so on and so on. I have 4 different medicences in it that I couldn't even try to begin to pronounce the names of them all, but they all have their own job and for the mostpart they all work to gether very well. I don't know why some or most people have then installed(like we are some robot lol) but I was in the Navy asa Seabee(Steel worker) and for 2 solid years I was picking up 150# plus everyday. When I got out(this is after I had a back surgery while I was IN the service) Well, long story short, I shattered 4 discs in my back and blew out both my knees. Hence the reason I was boarded out of the srevice (getting out due to medical problems) I was taking up to 10 or 12 Perticiot a day, muscle relaxers. sleeping meds etc. etc. etc.. I went to an appointment after an apointment. After 6 surguies I couldn't take any more. Someone told me abouut this pain pump and the VA didn't even offer anything close to the pump. Well, the pump was a God send. I love it. Now my only problem is I moved to another state and I can't find a doctor that will fill it for me. I don't know what would happened if I have to have this thing taken out. It won't be pretty. Please excuse the spelling.                                                                                                    

  • Jason
    Jun. 14, 2010

    I had my pump impalnted in Dec. 2009 and to this day have the worst abdominal pain at the implant site. Furthermore, I am receiving an extremely high dose of Morphine and Clonadine for the original back pain with limited or no comfort. Now I read about this recall for my model. If I read it correctly it was under recall back in 2008 and it is still being...

    RHMLucky777

    Read More

    I had my pump impalnted in Dec. 2009 and to this day have the worst abdominal pain at the implant site. Furthermore, I am receiving an extremely high dose of Morphine and Clonadine for the original back pain with limited or no comfort. Now I read about this recall for my model. If I read it correctly it was under recall back in 2008 and it is still being implanted? Anyone have similiar problems/concerns?

  • Angie Roberts
    Jun. 03, 2010

    There have been 5 "recalls" on Medtronic pumps in the last couple of years.  3 of the 5 were due to change of verbage in labeling.  A label change with the FDA classifies it as a recall - this is your government at work.  The other 2 were actually pump related:

    Battery failing after 7 years (in a pump designed to last 4-6 years).  Incident...

    RHMLucky777

    Read More

    There have been 5 "recalls" on Medtronic pumps in the last couple of years.  3 of the 5 were due to change of verbage in labeling.  A label change with the FDA classifies it as a recall - this is your government at work.  The other 2 were actually pump related:

    Battery failing after 7 years (in a pump designed to last 4-6 years).  Incident of failure after 7 years:  8/150,000 pumps.  Medtronic went to the FDA voluntarily over a .0000533 chance of failure. 

    Lack of propellent found in 23/10,000 pumps.  0 pumps were implanted in patients because Medtronic specialists are in surgery with the doctors making sure all is correct before anything gets implanted in a patient.  This was a .0023 chance and again, Medtronic went to the FDA voluntarily.

    All pump "recalls" are classified as a Class 1 recal due to the fact that anything that can cause a pump to stop infusing can be life threatening IF the drug in the pump is Baclofen, for severe spasticity.

    There is another pump in Europe, Prometra, that has had 5 complaints (107 patients implanted) of malfunction of the pump resulting in explant due to having an MRI. How frequently do patients need MRI's?  More accurate? No. Clinical accuracy of Medtronic pump is 101%, Prometra 95.3%; Reliability - Medtronic 98.3% event free at 48 months; Prometra 83.6% event free at 6 months; Medtronic pumps implanted over 150,000, Prometra, only 107.

    Granulomas at the tip of the catheter is caused by higher than 25mg/ml concentration of narcotic and a high flow rate.  Many docs are starting to go with something called Microdosing with great success at pain control which eliminates any concerns about granulomas.

    Go to Medtronic's website to find a physician - many issues with the pump have to do with the managing doctor's lack of knowledge or the pump was implanted in a person that shouldn't have had one implanted in the first place.  Patient selection and appropriate candidates are very important for good outcomes.  Pumps aren't for everyone, but in appropriate candidates, the results are good.

  • Anonymous
    wife of a pain ...
    May. 28, 2009

    My husband has had his pump since Jan. 2006. After going through the meds to find the right one, they have found that morphine works best for him. He has had no problems with the pump itself only the doctors. One new one set the meds to high and he went into a diabetic coma. We didnt even know he was diabetic. It seems as if they come and go very quickly. The...

    RHMLucky777

    Read More

    My husband has had his pump since Jan. 2006. After going through the meds to find the right one, they have found that morphine works best for him. He has had no problems with the pump itself only the doctors. One new one set the meds to high and he went into a diabetic coma. We didnt even know he was diabetic. It seems as if they come and go very quickly. The doc who put the pump in retired shortly after and I think we have gone through 3-4 more in the same clinic until the clinic changed all together. Now their moving again with new doctors. We also drive 2.5 hours to have the pump refilled almost every 3 months. The drive is miserable for my husband but I cant seem to find any doctors closer then Seattle, WA who manages the pumps. The pump has been wonderful for him. He use to eat the pills like candy and it still didnt mask the pain. But now he rarely takes orals and the pump manages the rest. Does anyone know of any doctors who manage pumps in Washington? Preferably not in Seattle. Thanks

  • Randal
    Apr. 06, 2009

    Greetings all: I just had a pump implanted in November of 2008. I have the

    model# 8637-20 so perhaps they made some changes but obviously they are still using and maintaining them. I'm guessing the problems were with the older models.

    I was informed of the issues with the tips of the catheters but read somewhere that they contributed the problem more...

    RHMLucky777

    Read More

    Greetings all: I just had a pump implanted in November of 2008. I have the

    model# 8637-20 so perhaps they made some changes but obviously they are still using and maintaining them. I'm guessing the problems were with the older models.

    I was informed of the issues with the tips of the catheters but read somewhere that they contributed the problem more so to the flow of the medication. I'm hoping the issues are resolved anyway as this has been the best way to manage my pain in four years. I'm still having some breakthrough pain and side affects but as far as the core pain problems this has been a huge breakthrough for me.

    Good luck to all.

    Rooster.

  • Anonymous
    Melinda
    Jan. 07, 2009

    whoever told you doctors have stopped medtronic pumps doesn't know what they're tallking about. I have had mine since 2000 and still have it.  I received Methadone and Clondine in my pump and I've never felt better. I'm now off all the C2 oral  narcotics.  I live in Iowa and have to travel to Illinois as no one in Iowa does Methadone. I suggest...

    RHMLucky777

    Read More

    whoever told you doctors have stopped medtronic pumps doesn't know what they're tallking about. I have had mine since 2000 and still have it.  I received Methadone and Clondine in my pump and I've never felt better. I'm now off all the C2 oral  narcotics.  I live in Iowa and have to travel to Illinois as no one in Iowa does Methadone. I suggest you get on medtronic's website and contact them.

  • Anonymous
    Anonymous
    Aug. 27, 2008

    Hello,

        I have just had my pump replaced somewhat against my will. My problems have always been with the catheter clogging yet the insisted on replacing the pump. My doctor disappeared and I was never told about any recall. presently the pump is set so low that I have no idea whether it is working. I now see that there is a recall on...

    RHMLucky777

    Read More

    Hello,

        I have just had my pump replaced somewhat against my will. My problems have always been with the catheter clogging yet the insisted on replacing the pump. My doctor disappeared and I was never told about any recall. presently the pump is set so low that I have no idea whether it is working. I now see that there is a recall on the new one also. Who is responsible for telling patiants about these recalls? I don't know what to believe anymore. The old pump needed 5 catheter revisions the last of which has left me with considerable back pain. All I wanted was to go back to oral medications and instead I got new doctors and a new pump that may or may not funtion. it all seems rather strange to me.

  • jody
    May. 23, 2008

    Hi I too have a Medtronic pump only mine is currently only filled with saline due to the fact that I could not tolerate either morphine or dilaudid. So I just take meds by mouth for now but I heard about the recall and told my pain clinic and it was the first they had heard about it. Now this is the first I have heard about Pain clinics not even installing...

    RHMLucky777

    Read More

    Hi I too have a Medtronic pump only mine is currently only filled with saline due to the fact that I could not tolerate either morphine or dilaudid. So I just take meds by mouth for now but I heard about the recall and told my pain clinic and it was the first they had heard about it. Now this is the first I have heard about Pain clinics not even installing the pumps anymore at all......May I ask where you are from? Do you know if this is all over the country or what? Also is it just because of the granulomas? I see that none of the experts have answered your post and I wonder what they would say about it. I havent heard anything anywhere else than here about this. I am just curious because I have this pump sitting in me for no reason at this point and I had hoped that maybe in the future I could use it. If not then I might as well get it taken out......

    Let me know anything else you know please! THANK YOU

    Jody

    • agbtg7
      Jun. 13, 2010

      Please go to the following web site: http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm062437.htm

       

      You will find that this only applies to pumps made prior to 1999 and it had to do with a problem with some of the motors. So, if your motor and pump was manufacturered after 1999 you don't even have to be concerned...

      RHMLucky777

      Read More

      Please go to the following web site: http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm062437.htm

       

      You will find that this only applies to pumps made prior to 1999 and it had to do with a problem with some of the motors. So, if your motor and pump was manufacturered after 1999 you don't even have to be concerned about this. All one has to do is read carefully and they will see the problem and everyone who had one of those pumps were notified. MGM.

    • devona
      Jun. 15, 2011

      i have found doctors that still deal with the pump, however, the major issue is that if they didn't put it in; they will not take you. even medtronic hasn't been able to help. this leaves us in a bad spot. my doc is horrid and unless i get my pump out, which barely helps now and he says can't be turned up anymore, i'm stuck with a man who refuses to do anything...

      RHMLucky777

      Read More

      i have found doctors that still deal with the pump, however, the major issue is that if they didn't put it in; they will not take you. even medtronic hasn't been able to help. this leaves us in a bad spot. my doc is horrid and unless i get my pump out, which barely helps now and he says can't be turned up anymore, i'm stuck with a man who refuses to do anything to help. i have rsd and am at a 8 daily.

    • Anonymous
      nomorepain
      Apr. 03, 2012

      For those of you who have chronic pain syndromes PLEASE CONSIDER THIS NEW TREATMENT, especially for NERVE conditions. Please pass this information on to anyone you feel might benefit from this.  It is a newer device and is gaining a lot of attention, but we need to help pass along this options to those who also suffer endless pain that robs our lives...

      RHMLucky777

      Read More

      For those of you who have chronic pain syndromes PLEASE CONSIDER THIS NEW TREATMENT, especially for NERVE conditions. Please pass this information on to anyone you feel might benefit from this.  It is a newer device and is gaining a lot of attention, but we need to help pass along this options to those who also suffer endless pain that robs our lives away from us. 

      During your first consultation, most places will do a trial on you.  It has been my experience that most patients will know if this will work for them just by this one treatment.  If you do a search on "diatomes" you will see the body is divided into several sections, and depending on the diatome section your pain is in, this is where these electrodes are placed onto for approximately 45-mins. It is important that to get the best relief, you have the 10 recommended treatments within 2 weeks without interruption (ie. M-F for both weeks).  If you space the treatments out longer, the success rate drops a bit; and you want the best outcome.  *MOST INSURANCES WILL PAY FOR THIS TREATMENT!

      PLEASE I BEG OF YOU TO TRY THIS NEW DEVICE.  It has been life altering especially for RSD syndromes which are so difficult to treat.  Now you have hope that there may be an new treatment option!  Also, for those of you who suffer from Pudendal Neuralgia; they are having a 50% success rate right now. 

      NEVER GIVE UP HOPE!

       

      Conditions treated include:

      • Chemotherapy-induced peripheral neuropathy (CIPN)
      • Phantom limb syndrome
      • Post-surgical neuropathic pain
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      • Postherpetic neuralgia (PHN)
      • Back and Neck Pain
      • Chemotherapy Related Cancer Pain
      • Failed Back Surgery Syndrome
      • Neuropathic Pain
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      http://www.sperotherapy.com/

       

      http://www.calmarett.com/