Defective Pain Pumps: Medtronic Fails to Protect Patients

I really feel for chronic pain patients. Over the course of my 32 years in practice, I have seen so many fine folks who are in pain 24/7/365. The lives of chronic pain patients center around what they can do to get relief. They often look to anything that can help reduce or relieve their pain.

Medical technology has entered the pain field and offered many solutions to pain patients, that are alternatives to powerful and highly addictive narcotics. Medtronic designed an implantable pain pump that would deliver medication directly to the patient at pre-set intervals. This could have several advantages, including providing consistent levels of medication and avoiding the risk of the patient accidentally over-medicating or over-dosing themselves.

The pump was designed to be implanted directly into the patient’s abdomen and connected internally by a catheter to the intrathecal space of the spine. In this way, the medication can be directly targeted to the pain receptors in the spine. The pump was only approved for use in certain patient populations and with certain drugs. For example, it could be used to deliver morphine for the treatment of intractable chronic pain or methotrexate for the treatment of pain associated with primary or metastatic cancer. As well, it was approved for delivery of Baclofen for treatment of severe spasticity.

However, the Medtronic Synchromed II Pump has faced many problems, leading up to an FDA recall. According to the FDA, Medtronic was required to recall the SynchroMed II pump, because “a software problem may cause unintended delivery of drugs during a priming bolus procedure, used to quickly deliver a large dose of medication from the device to the patient’s spine.” During this time, patients may also “receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid followed by a period of reduced drug delivery after the priming bolus.

During this time, patients may also “receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid followed by a period of reduced drug delivery after the priming bolus.

Other problems which have been observed with the pumps include:

  • Motor stalls.
  • Catheter becomes clogged.
  • Catheter disconnects from the pump.
  • Battery dies prematurely.
  • Soft ware misdirects the amount of medication.
  • Pump short-circuits.
  • Priming bolus fails.

Sadly, a malfunctioning pain pump can lead to a host of problems, including delivery of a fatal drug overdose to the unsuspecting patient!

The FDA, reacting to complaints, conducted multiple inspections of Medtronic’s manufacturing facilities between 2006-2013 and revealed many concerns. Part of the problem was the way in which Medtronic dealt with complaints about devices that were reported to have malfunctioned or caused serious injury to a patient. AS the FDA stated, the manufacturer is required to investigate and implement changes under these circumstances. But, the FDA didn’t stop there. They asked the Justice Department to get involved. That led to DOJ filing a complaint which alleged that Medtronic and two of its senior executives had been distributing medical devices into interstate commerce that were adulterated because they were not manufactured in accordance with current good manufacturing processes. The DOJ action led to a consent decree in which Medtronic and its leadership committed to make changes in their process that will “benefit the American public by ensuring that their products are safe and effective for patients.” According to counsel for the DOJ, “The DOJ will not permit medical device manufacturers to shirk their responsibility to ensure that the devices that patients rely upon are safe.” I say, GO DOJ!

“The DOJ will not permit medical device manufacturers to shirk their responsibility to ensure that the devices that patients rely upon are safe.” I say, GO DOJ!

In conclusion, I suppose this isn’t the first time you’ve heard about a defective medical device and I can almost promise you it won’t be the last. As patients, we have very little control over what products are put inside our bodies and we therefore, must place extreme trust in corporations who manufacture these products. Unfortunately, we see time and time again, that corporations are perfectly willing to put profits over patient safety until they are forced to stop and made to pay for the harm they have caused.

Don’t you wish the bad behavior would end so that I would run out of things to write about? Until then, friends and colleagues, stay safe out there! Kay Van Wey

Comments 12

  1. Maillady42 says:

    Wow I’m shocked at all the complications & it terrifies me to hear of these! I’ve had multiple pumps since 2006. I have had complications in 2 of my Medtronics Pumps. Both of which were flipping upside down & the tubing was getting kinked & wrapping around the pump when I would bend over. Thank God, even after they were kinked more than 50 times. They did not break inside me. Both of these pumps were in my abdomen/side. After having revisions on both pumps they decided to put it in my back. I’ve not had any issues with it flipping over, however it is more uncomfortable in my back. I’ve had 1 occasion recently where I was got my pump filled & after my nurse left I started feeling very lethargic and out of it. Apparently, when my nurse was pulling the needle out of the port some of the medication got into the subcutaneous tissue and was overdosing me. Thankfully, it wasn’t enough to kill me! That was very scary. The other issue I had was my doctor thought because I had been on Dilaudid for so many years, to switch me to fentanyl. FYI, it takes 3 days for everything that’s in your catheter in your spine to run through your system. So, I still had the Dilaudid running through my catheter, and gradually the fentanyl replaced it. Within those 3 days I started getting very sick. I had the most horrible obnoxious, sweet, taste, and smell that seemed as if it was coming through my skin, and I could not get rid of it. It made me so nauseated with violent shakes & vomiting. Apparently fentanyl has a sweet taste to it, which I did not know until later that that is what it was. I was actually having a bad reaction to the fentanyl. After going through 3 days of hell & trip to the ER because I was having a hard time breathing, my doctor was finally able to take it out of my pump and replace it with the old medication. With that being said, it still took another 3 days for the rest of the fentanyl to work its way through my system. So again, I was still sick even after the medication was taken out of the pump, but each day got better. Thank God I wasn’t so highly allergic to it that it killed me immediately! It makes me wonder if we shouldn’t have a nurse or a doctor administer an IV regiment and trial run of medication to see how we’re going to react to it rather than put it in our pumps first to see if we are going to be allergic to it. Especially if it’s going to take that long to run through the catheter, bc if you allergic you’ll need it out immediately. You would think that should be a rule to go by. The issue I’m having now is my pump battery is going to be running out. My end of life for the battery will be in the next 3 to 4 weeks. However, it can start malfunctioning according to my at home pump nurse prior to that. Malfunctioning as in slowing down and pausing and not providing the proper dosing. I’ve been preapproved by insurance to get the next pump replacement surgery done, however, my surgeon refuses to do the surgery until after my open wounds on my ankles heal. I have lymphedema in my legs from my cancer, and deal with open wounds every year, which sometimes takes months to heal. The wound center does not think my wounds will be healed by the time my battery runs out. I receive absolutely zero oral pain medication, I’ve started having nights where I’ve been having so much nausea that it’s making me wonder if it’s already starting to malfunction. I know that my battery alarm will go off when it goes completely dead. I was advised to go to the ER when this happens. I just can’t imagine dealing with my open wounds on my ankles, and having to deal with going through withdrawal on top of it. I am hoping that I will be able to get some oral medication’s to help me through this transition. Because I had, an on the job injury, and I am dealing with the federal government because of my job, I have to go by what the DOL says, and they say if you have a pain pump, you don’t need any oral pain medication, and therefore they refuse to allow the doctor to give it, but I would think if my pump isn’t working, they would have no choice. I feel like a protocol needs to be in place before it all happens and that’s what I’ve been working on getting done, but I keep getting a run around. It’s very scary to say the least especially after hearing everybody’s issues on here. Ty all for sharing!

  2. Jessie says:

    I was in the Hospital twice. I didn’t know until three days ago, that they were suppose to let us know. I have a medtronic pain pump.

  3. Kathleen Zinda says:

    My removal of pump has caused me even more pain. Unable to sleep , walk far, stand long. My life is gone and now no one will help my pain
    All I do is sit in chair in my apartment .

  4. Keith says:

    I’m canceled my third pain pump due to prior failures and massive scar no get it. Move wrong once and the medication goes no ware. It’s all about the money

  5. Pam Clark says:

    I had a Medtronic Pain Pump since July 2000, several replacements over the years with one complete catheter revision about 15yrs. ago. Several weeks ago my Dr. did a dye study on my pump and thought he found a kink at the pump site. This past year or so when the he would drain my pump he would get way too much medicine out and was still at a high rate of pain and at 15mcg. I have a type of Neuropathy and have had all types of meds thru my pump before finally getting Preilat. Today I had a surgeon remove my pump, which was due to be renewed and since my catheter had blown a hole in it, he left the old one in place and put in a new one. In the past the other surgeons removed the old catheter before placing new one. I’m asking is this a new common practice now among surgeons? I already haven pieces of the blown cath. floating around in my body as it is, I really don’t like the idea of having an extra non-functioning item in my spine. I would appreciate a response. Respecfully, Concerned in Arkansas

  6. Joe Tuinstra says:

    I got a medtronic pump around 3 years ago. It made me go septic. After they put a new one in it worked fine until 3 months ago. I kept telling every dr i saw i was in so much more pain. Here the stupid pump had an issue with the catheter. It put me in the hospital due to my blood pressure rising so high (243/160) because of the pain. To top it off they wouldn’t give me pain meds because of the pump. I found out the pump was at fault when at my pump fill they pulled 35ml out of a 40ml pump.

  7. Cheryl Smith says:

    My pain pump broke the catheter tubing fell from pump. The tubing fell in the flank area. During the replacement the tubing has now caused balance issues. Severe pain in the sciatic leg on my my right leg.
    After the surgery I was sent home. Nov 5th on Nov 6 evening time my husband he found me not breath @ gasping the medics came and tried to wake me. They gave me a shot they give to people who overdose. Briefly I awoke and heard what did you take? I was able to say it’s my pump. After that I only was aware of my surroundings in the morning of nov. 7th. I saw I was in the hospitable. I called the nurse and asked when they would call my husband. She said a doctor would be seeing me. Later my husband called a told me what he knew. Because of Covid he could not be able to visit.
    When you have almost 3 days missing is hard. It has caused balance issues panic attacks nerve issues. Bowel issues. Short term memory loss. The doctor who I saw in the hospital said my pump caused me to overdose. They had shut off my pump I would need to have my doctor to turn it on again.
    The tubing has dropped in my flank area and could not be removed for safety issues.

  8. Duane Satterfield says:

    I had a Flowonix pain pump installed approximately 3.5 years ago. Been working great until about 4-5 months ago. I went in for 90 day refill late January 2021. PA withdrew 20 ml of medication. It is 20 ml pump. So pump had failed at least 90 days ago. My pain levels keep increasing to where now it’s 8.9,10 everyday!! Don’t subscribe oxycodone anymore. So have Suboxone which doesn’t cut pain the well!
    Has anyone else here had a Flowonix pump? What were your results. I have CRPS, Complex regional pain syndrome in my right foot for 20 years. Also have a med Tronics spinal cord Stimulator that has really helped me over the years. Thanks for your input greatly appreciated!
    Here’s to a great 2021!

  9. terri theodore says:

    I had a medtronic pain device serial#NGV708001H Model#8637-40 implanted 21-Oct-2019 and taken out Oct. 2020 due to a malfunction. The morphine and lidacaine leaked into my veins and paralyzed me almost completely! If my pain Doctor hadn’t come to hospital and put me in ICU I wouldn’t be writing you this letter now! He found the problem and drained the medicine out of my body and what was left in the pump. The agony I felt and still feel was to say the least was excruciating, not to mention what my husband and family went through! My eyes aren’t the same, my eye Dr. said it’s from the paralysis. Needless to say I’m back on opioids again and the pain is much worse! I didn’t realize how much pain the pump helped me until it was gone! I never want to go through this again and will never have another pump or device put into me again! I’ve gone through physical therapy but still walk with a cane. Medtronic has not got back to the Dr. or myself to explain what went wrong. I want to be compensated for my near death experience and the pain I must endure for the rest of my life!! Any advice from you would be appreciated! thank you, sincerely Terri Theodore

  10. Gail Acerra says:

    I am intended to go with the medtronic pain pump, but now that i have read the bizzare problems that go with the pump. How can this happpen ? And when the problems happen, they still went on with the trials and thats disturbing. The pain im in is like ive been hit by a car or i feel that ive been beat up and thrown into the street. I have had a heart attack and a stent implanted. I now have disc disease, stenosis, thyroid disease, diabetes and now i have a ulcer. Before i was injured i was alive, and was with family all the time, now i sit or lay. I can only stand up for about 2min tops. the screws have come loose from my fushion. I have bone spurs, and a slew of problems, that have come out of a failed surgery. I am on a low dose, and i tell my dr. that i cannot do anything, grocery shopping, laundry, I feel like im going to die, im on a 15mg of pain meds, i tell dr that its not helping, he told me no. I am 65 yrs old if i stay in 1 place if i move an inch i suffer, I dont understand why my dr wants me to suffer, no quality of life. “Docter Do No Harm”. I am being harmed and it going to kill me. Im scared, Gail

    • In 20 years I’ve done very well with an implanted Medtronic pain pump until last week when my alarm sounded at 1210a and the NP confirmed the next day….full motor failure. I’m broken, in pain, meds being withheld by my son, and the pain mgmt office, as of yesterday, had nothing to offer but go home in withdrawal. I’ve been seeking out options to cope with this but after 13 hours in the ER Friday was told they couldn’t admit me anywhere. There are no bed available until Friday and I feel angry, abandoned and am in intractable pain.

  11. Karen Johnson says:

    Had medtronic pain pump implanted in September 2018 and taken out in September 2019 due to hardware failure, painful morphine pump, now have seizures, muscle spasms and weakness constantly, eyesight problems, and other issues as well

Leave a Reply

Your email address will not be published. Required fields are marked *

Trending Articles

Find a Lawyer   /   Ask a Question   /   Articles   /   About    Contact  

© Copyright 2022 | Attorney at Law Magazine | Privacy Policy