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Important lesson with Metronic Pain Pump

stlrocksstlrock Posts: 2
edited 06/11/2012 - 9:02 AM in Pain Management
Hello Everyone,

I am brand new here, and would like to thank all of you for your posts concerning back problems. I am a 47 year old male with 5 back surgeries to date. 4 Lumbar, and 1 cervical. My problems started in 1999, and in 2005, I had an interthecal pain pump installed in my right stomach area. The pump has worked fine over the years, but the past 2 months have been a nightmare.
About 6 months ago, I started seeing a new pain doc. I live in Missouri, but my new wife lives in Florida. So we are spending the winter here, before moving back to Missouri later this summer.
On my first visit to my new pain doc, he noted that my eri on the pump was ate April of 2012. At the time, he said he
was not concerned about puting a new pump in right away, as the pain pumps are designed to last for months past the ERI
date. I thought that was a bit odd, but trusted my doctors opinion since he was the expert. On March 22 I had an appointment with my doctor to have my pump refilled. When he started his readout of my pump, he must have been alerted to the fact that my battery was set to expire at the end of April and that we needed to get this done right away. I was a little alarmed by his sudden concern, because of the severaL occasions when he told me we were in no hurry. So I went ahead and scheduled my pump replacement procedure for April 9th. The next day I was on the road back to Missouri with my wife and step kids as they had started their spring break. On the drive up...I noticed I was extremely tired, flushed and on edge. I chalked it up to the long drive and the pain I was in. A couple of days later, I got a cal from my pain clinic advising m, I decidede that I needed a psych eval before they could the replacement. I told the lady on the phone that I had already had a psych eval that was required when I had y initial pump installed, and as far as I knew....was not required to have one for a replacement. Four days and many phone calls later, I was getting nowhere and it was decided that the procedure on the 9th would have to be postponed until I got back to Florida, and went to see them in person. On the day we were set to drive back to Florida, my wife and I decided to leave me at the house in Missouri because of the long drive, and how horrible I was feeling. Fortunately, I was able to find an extremely cheap
flight back to Florida for the 12th of April. On 3 April, my pump started to alarm. It was a long tone alarm that is a warning. I had been feeling better, so I chalked it up to the fact that my ERI date was coming up at the end of April.
The alarm kept going off once an hour. Between April 3rd, and the April 12, I kept getting sick, then better....sick....then better. It felt like I was going into withdraw for a day or two...then I would feel fine. I flew home on April 12, and went to the doctors office first thing the next morning. The doctor checked my pump and said it was working fine. He turned off the alarm, but warned me that we needed to get the pump replaced as soon as possible. He also apologised for all the back and forth phone calls I had to make to his admin office, and said he didn't know what was going on. I told him that I would be more than happy to take another psych eval, if that would hurry the process up. So I made an appointment on the 16th for a psych eval at their min office downtown in Tampa. That night I started to feel horrible, and my alarm started to go off every 10 minutes starting around 3am. At this point I was starting to get scared as my body started to go into complete withdraw. (If you have ever gone through it....you know how horrible it is) I cancelled all of my engagements for the weekend and first thing Monday morning, my wife had to drive me into the main office for my psych eval. The eval was just a formality, but I told the doctor that I was critical alarming, and could he please have someone check it out before I left. I had two people try to read the pump, but they could not get it to respond to the device they use to read it. They asked me if If I could wait for awhile, as they wanted to call the the medtronic rep to come out and look at it. When she got there, she was able to communicate with the pump, and said it had stopped working. She said with the model I had, there were problems with the battery, and that the reason I was getting sick the past 6 to 8 weeks was that the model I have has been known to start and stop due to a defect. She seemed very concerned and tried to see if we could possibly get the new pump installed that day. Apparently, that was not going to happen because medicare still had to give its approval and they still had not done so. The rep then told me that she was going to turn off my critical alarm, so it wouldn't keep me up all night as it had done for the past couple of days. She also said that I had an appointment at 8am the next morning with my regular pain doctor in order to figure out what oral meds to take until I could get my new pump in. I told the rep that they might as well take me to the emergency room as I would not last another night in complete withdraw, nor would I put my family through it. She ws able to get another pan doctor that worked at the main office to write me some prescriptions to deal with the withdraw, and cover the pain meds I would have received from the pump. I went home, and around 11pm that night, started to feel better. Around 3am, I woke up to the sound of my critical alarm going off again. I thought that was strange because the medtronic rep told me she had turned off the alarm. I fell back asleep until my wife woke me up at 7am to get ready for my appointment. At this point, I felt completely out of it. We make it to the doctors office, and when they take my vital signs, my wife and I were shocked that my blood pressure was 105/63. When the doctor started to probe the data in the pain pump, he said that the pump was working again. This meant that I now had way too much medication in my body, and that explained why my blood pressure was so low. I was over dosing because the pump was sending me meds, as well as the oral meds I had been taking. My doctor then turned off the alarm, and programmed the pump to only give me approximately 1% of the medications that I had been receiving from it. He told me to continue with my oral meds, and we set up an appointment for Monday, April 23 to have my new pump replaced. Today is the day before the surgery, and I still have no idea if Medicare approved the procedure. This whole week has been a roller coaster trying to stay ahead of the pain, and keep the dreaded withdrawls away. The thing that makes me most angry about this incident, is that I found out that last summer, the FDA and Medtronic put out a class 1 recall for the Synchromed 2 pump, and specifically, for model 8637-20..(thats the one I have). I wrote this novel because all of us in the pain community have enough problems as it is. It is bad enough that we have to battle chronic pain every day, let alone deal with all of the BS that comes along with it. If you have a Medtronic pump, pleas check your model n umber, and if you have one that is being recalled, please discuss it with your doctor. Show him this posting if you feel like it. Nobody should have to suffer the way I have the pas 8 weeks. If you have any questions, or would like to talk further...Feel free to send me a message. Peace....Chris


  • First let me welcome you to Spine Health..

    Now I would like to clear up a few things.

    To find out if your pump is on the recall list you go by the serial number! The serial number is on your print out sheet.

    This problem ONLY occurs when your pump is due to be replaced, NOT before that. There is only a very slight chance of this ever occuring even if your battery is on the recall list. I have a Medtronic Pain Pump and it IS on the recall list but I will not worry about mine until it's due to be replaced.
    I will not let anyone postpone my replacement date either.
    I am sure that changing pump Doctors when you did, did not help matters either.

    I would think your insurance is what is holding up it's approval.....not medtronics. Medtronics has already said your pump muct be replaced after so may years.

    I am sorry you have had to go thru this and I do hope your new pump works out great for you.

    I also hope I have cleared up any confusion about this recall. No one has had their pump removed because of this recall and chances of this ever occuring is very slight.

    Best of luck to you Chris.

    Patsy W
  • Hi Patsy,

    You are correct on some items, however:

    A: Medtronic never notified me of the recall

    B: A medtronic rep told me that this does not only occurr at the end of the pumps ERI

    C: They did not replace the recalled pumps with my model number on it because of the cost involved.

    D: 1 person has died, and 55 others have become seriously ill such as myself. This is what prompted the FDA to make a class 1 recall with my pump.

    I don't know about you, but I find some serious issues here. Did medtronic screw up....YES

    I posted what I did so that others with my pump model would be aware, and make some informed decisions.

    I hope this clears up anything from my previous post.

    Take Care


    My pump malfunctioned before it's shelf life was over. I was 1000 miles away at the end of March when it malfunctioned. That is a huge problem.
  • I just noticed part of my last comment is missing.
    Blame that on the solar flare!! It has made my laptop go crazy. It will wipe out part or all of any comment or e-mail I am typing. It's nuts!! It just wiped out a comment just like this one that I was getting ready to post!!
    BTW.... this is the same recall that was issued last year so most of you already know about it.

    To find out if your Medtronics pain pump is on the recall list....type in "List of device recalls" into a search box. The Medtronic recall is at the bottem of the list....click on it. Click on the "Device identication web page". That will take you to the page that has a box to type in the serial number that is on your print out sheet.

    If your pump is on the recall list....do not panic but do call your Doctor the first chance you get and find out what to do about it...if anything.

    Thank you for the warning Chris. I am so sorry you had to go through all that you have.

    But as I said this is the same recall that was issued last year so most of us may already know about it. Best of luck Chris. I do hope we will continue to see you here.
    Patsy W

    W.....this is the same recall that was issued last year

  • Wow that is terribly scary.

    If your old 1992 Ford truck has a recall you get a letter from Ford....

    You can not tell me that they can not send out a letter to people whom have these in their bodies so they can get them checked out etc in a reasonable amount of time.

    Don't get me wrong, I am still all for using a pain pump if the SCS trial fails. But I would hope to expect more from a company like this. It makes me wonder if this is a decision decided on by the FDA rather than Medtronics.

    Thanks for sharing your story Chris and "Welcome to Spine Health".

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