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Medtronic Synchromed II Infusion Pump Recall: Defective Batteries

  • Written by: Staff Writers
  • 18 Comments

Defective batteries in some Medtronic SynchroMed II implantable infusion pumps, which the manufacturer has reportedly known about since 2009, have led the FDA to determine the pumps pose a serious risk of health problems or death for consumers, resulting in a Class 1 medical device recall. 

Earlier this summer, Medtronic sent a letter to doctors warning that it had received at least reports of 55 battery problems with SynchroMed II infusion pumps, where the batteries became covered with a thin film that may cause the device to fail.

On Monday, the FDA announced that the battery failures and Medtronic’s warnings constitute a Class 1 recall, which is the most serious type of classification.

The Medtronic SynchroMed II Implantable Infusion Pump recall affects units with model numbers 8637-20 and 8637-40, which were distributed between May 2004 and July 8, 2011. Patients can visit a Medtronic device identification webpage and enter their device’s serial number to see if it is affected by the recall.

Despite being a recall, it is unlikely very many of the devices will be retrieved. More than 140,000 patients have already had the infusion pumps surgically implanted to release painkillers into the body.

The FDA and Medtronic recommend recipients of the defective infusion pumps make sure they carry their patient identification cards with them at all times and contact their doctor immediately if they hear the device begin to alarm or they begin to suffer a return of symptoms that the device is supposed to treat.

The sudden failure of the painkiller pumps may cause a patient to no longer receive medication, which can result in the return of pain symptoms and could also cause them to suffer drug withdrawal. In some cases, like with patients receiving intrathecal baclofen to treat multiple sclerosis, the withdrawal symptoms could be life-threatening.  The pumps are designed to have an 84-month lifespan, but the premature failures have occurred as early as 48 months, the company has warned.

The company indicated in a press release issued in July that it has been aware of the problem since July 2009, when it sent a letter to physicians.

A new battery design has been put into place for future SynchroMed II pumps in Europe, Australia, New Zealand, Canada, Africa and India. Medtronic is still seeking approval for the design for pumps sold in the United States.

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18 comments

  1. Julie Reply

    Hi…I am a recipient of one of the aforementioned Medtronic pumps. I am currently in Puerta Vallarta and NO-ONE seems to be available to help with the situation on hand. At this point my pump is on “critical alarm”, beeping twice three times.
    No-one seems to want to take responsibility for this. I’m disabled, on Medicare and have no money to return to the U.S., and there is no local doctor here (nor a Medtronic rep) to assist in the situation. Want a story? I have one for you. This is my THIRD pump implanted by Dr. David Schultz of MAPS (Medical Advanced Pain Specialists) in Maple Grove Minnesota. Trying to get in touch with them is impossible and, of course, a call to Mexico is “costly” to them…I guess more so than my life.
    I don’t have Baclofen in my pump. There is Fentanyl, Bupivicaine, and Clonidine. Withdrawal symptoms are worse than those of Heroin and the local doctors here can only do so much. Please advise. I am willing to fly to Los Angeles ASAP if I can find a doctor who is willing to correct this problem and would be more than happy to speak with you regarding my history with the three (3) pumps I have had implanted since 2000 from Medtronic.

  2. Anthony Reply

    I had the same pump implanted in October, 2010. Several months later I mentioned to my doctor that it seems like the pump is not working at times. My doctor has gone so far as to tell me I need a psychiatrist!! I have not left my apartment except for medical appointments in the past year. I called Medtronic several times since I discovered the recall – January, 2012. All they say is, “Anything we say might be construed as medical advice and we are not licensed medical practitioners. You must consult with your doctor”. That’s the same doctor who says I need a psychiatrist because I am ill from withdrawals and having severe pain! I want this pump out of my body!!!

  3. Tinktink Reply

    I also have a Medtronic synchromed II pump with morphine and clonadine. This is my 3rd pump. My first pump was in about 6 yrs and because we knew the battery was getting old we changed. The 2nd pump also lasted about 6 yrs and I started having leg pain and was hearing a ticking sound. Almost like a clock ticking. It was not the alarm sounding so we changed it. I now have my 3rd pump put in April 2012 and was feeling wonderful and then it started …the pain returned and I heard that ticking noise. My dr also heard the ticking noise and doesn’t know what to make of it. Also had a Medtronic rep listen to it and even she was clueless. Will have this pump changed out to a new one if this ticking doesn’t stop. Has anyone had a ticking pump? I can’t be the only person in the world w a ticking pain pump. That ticking has to mean something. Can anyone help with this? Thanks

  4. Amy Reply

    I believe I am on my 3rd or 4th pump. One pump I started having terrible withdrawal symptoms, I turned white as a sheet, I was clammy, nausea & vomiting, shivering, and so forth. I was in an Emergency Room for over 20 hours because no doctor their had a clue on what a Medtronic pump was or how to treat me. Long story short, ended up going in for emergency surgery, my pain management doctor found that the catheter that connects to the pump and become dislodged. There is also a catheter that goes around to my spinal column to release medication and the tubing or rather the catheter completely broke off. My doctor went searching in my back for it and was never able to find it! I guess I have a piece of tubing floating around or by now, has probably disinigrated. So pump was changed out. It seems the next time the pump was replaced was maybe 6 months after having the new pump in due to an FDA recall on my pump. I get lost with how many pumps I have had but the next pump, I think was changed at proper time. Now, I am on my 4th pump and I feel like it is not work. I am coming up on having this pump in 48 months and I have return of symptoms. I can be seen regularly in my doctors office asking for a bolus dose. I told my doctor that they had a recall on this pump again and could there possibly be a problem. He uses his device to check the pump and says all is working well but I don’t feel that way. I feel a change in lifestyle and pain. I’m having to take my pain pills far more often and my husband sees a change in me. I don’t know what to do. My doctor said to call Medtronic and see what they say but it doesn’t sound like they will be much help. I’m convinced that either the battery life has slowed or it’s not pumpuing my medicine in the manner that it used to do. All I know is that I am in frequent pain and I have been using this pump for 11-12 years. Any suggestions you guys may have would be much appreciated. Thanks

  5. John Reply

    I am on my fourth pump since 2002. I tried to get a lawsuit going but no lawyer will touch it because you cannot sue medical device makers. My last two pumps were on the recall and after what happened I wish I had not had another put in. I worry that it will happen again and the withdrawal is really horrible.

  6. Sandra Reply

    I don’t get it. My husband’s pump stalled about 5 days ago. Medtronics is meeting with us at this doctor’s office tomorrow. I was hopeful that they would do the right thing. When a company has a recalled product, they should fix it. Why are they not required to? Now I am worried that they will not replace his pump and that Medicare will not pay for it. He cannot live without it. His quality of life will be decimated.

  7. eileen Reply

    had my 1st pump replaced last october (about 6 1/2 yrs old). i just found out motor started stalling in dec. 2011 and again feb 2012, march and may 2012. i also felt a flutter or vibration kind of feeling at the pump site 2 days ago. medtronic says 84 months, obviously this is not happening

  8. Kristy Reply

    I too am a synchromed ii owner and I HATE IT!!!! My pain doctor thinks i need to see a psychogist because my pump ticks like a clock. It also alarms for no reason and resets itself (or so I am told). I’ve had mine since December 2009 and the pocket that its in is very VERY PAINFUL (my upper left part of my stomach), i have horrible nausea and vomitting, pain, numb feet, an obvious area of swelling at the pump, very difficult to refill the pump b/c of the mesh its in, and they had over dosed me in the past (i went numb from the chest down and turned gray (but its not their fault when they were called…it only happened during the nighttime bolous kick)) Anyone have problems like this? Every time i ask the doc/pa about it they tell me that my pump is not implanted there (yea…i just oh so love to have that needle jabbed into my stomach every two months to have it filled), im not feeling those symptoms. My catheter had torn and floated WAY OUT of position. I ask for help, they refuse, i ask for a transfer and they refuse…they act like they own you and i feel very trapped. The physican assistant i see is now gone and im stuck wiyh the other one….the one who has broken Hippa by screaming my name, diagnosises, my current issues infront of a FULL WAITING ROOM!! He has also sexually harassed me about my large chest in front of my husband. Does anyone have any ideas on how i can get out? I thought i was entitled to a second opinion. Im soooo trapped. Can ANYONE HELP???

  9. Marlene Reply

    My significant other is on his second pump and second catheter. The first catheter broke at entry point and doc couldn’t figure out why it did so. The frost pump suddenly failed and while we waited doe medtronic to evaluate the reason foe failure, he went through withdrawal. We paid for the surgery to replace. The second pump which was under the “possible battery failure” list just failed and after 5 days of withdrawal it restarted itself, sending him into withdrawals Again. He is having it removed but guess who gets to pay for the surgery Again? We are going to seek legal advice. There has to be something that can be done to hold this company accountable

  10. Marlene Reply

    I forgot to mention in my prevous comment that my significant other has MS which makes his situation worse. Also, this is his second pump and catheter in 4 years. Both pumps lasted less than 3years

  11. kathleen Reply

    I JUST HAD A PUMP MODEL 8637-20 ON JAN 4 2013. BIG HUGE MISTAKE.I WISH I HAD RESEARCHED THE INFORMATION ON THE NET(SOETHING I NORMALLY WOULD DO) MY PAIN HAS INTENSIFIED AND I HAVE PAIN I DID NOT HAVE BEFORE. I ALSO FEEL TRAPPED. I HAVE NO CONTROL AND FEEL LIKE I HAVE TO URINATE 24/7. I AM SCARED TO DEATH. I WAS FINE ON MY FENYYNL PATCH AND FENTORIA BUT SLOWLY HE MY PAIN SPECIALIST DECIDED IT WAS TIME TO START CUTTING DOWN MY MEDS. I WOULD HAVE DONE ANYTHING WHEN MY PAIN SENT ME INTO ORBIT MY B/P WOULD GO SO HIGH I COULD NOT SLEEP EAT AND UNBEARABLE TO LIVE WITH. SO I SURRENDRED AND DID IT. I FEEL YOUR PAIN.NO-ONE TOLD ME ABOUT THE RISK THE RECALLS ONLY THE WONDERFUL BENEFITS. I FEEL BETRAYED I AM IN WORSE PAIN AND WHEN I AM HONEST ABOUT THE QUESTIONS AND CONCERNS I GET ACCUSED OF BEING DISRESPECTFUL.. OF COURSE THIS WAS TOLD TO MYHUSBAND BEHIND MY BACK.
    I AM SO DEPRESSED AND AL I DO IS CRY.

  12. sharon Reply

    My 85 year old Mother-In-Law had one of the recalled pumps implanted on July 22, 2011 after the recall date. She had her 1st pump fill on Aug 31, 2011 and went into respiratory arrest that evening. The pain doctor was called two times that night by the ER doctor with no reponse…they kept her on a respirator due to the continued infusion of morphine which they believe was the problem….the lax protocol from this pain doctor is what I believe to have been the cause. Getting an attorney to address this is next to impossible due to her age. This pain doctor totally abandoned her when his questionable practices caused her brain damage. She died 6 days later after taken off of the respirator. Medtronics had no right to provide a recalled pump and this pain doctor had no right to send her home without the proper monitoring of an elderly morphine naive patient with the morphine set to start after she arrived home without advice of what to watch for other than a possible upset stomach – and call them if she has a problem…..they won’t call back but then knowing what I know now I guess I didn’t expect them to. This is just a money making proposition for both Medtronics and the Pain doctors – I have researched this totally and find this doctor to be incompetient – or I should say those who work for him as he does nothing at his facility but sell. Lost his licence once for this for several years and my Mother In Law was under his care during this suspension also. What a guy!

  13. freeda Reply

    my husband got his first pump Dec.6 2005, things went fine for a while than he had his cather (tube) come loose. it was replaced, about a year later it came loose again and was replaced.. inFeb. 2012 he had it refilled, on the way home he starter going in and out his mind like he was Od ing called pain doc, he was out of state. his back up didnt know a thing about the pumps. sent him to a heart dr. had a pacemaker implant.a week later they desided to replace it. by this time he had laid passed out so much he got bed sores. and has to see a wound doc. he has had 3 surgeries on the sores and has still suffering from the body damage that this so called great pump has caused. he has had this pump all this thim and never had an alarm sound even though it has been empty a number of times. before all of this he had disc disease, but could move around with a cane now he has to use a walker and wheelchair. someone needs to put a stop to these pumps. NOW…….

  14. Randy Reply

    I had my first pump put in and they used a mesh pocket, and by the time I put in my third pump the mesh became a problem. My doctor told my care taker that the mesh was a problem, but could not take it out. Then the next day told me about the mesh and that he was very concern about it and he wanted to keep a close eye on me. 10 days later he took out the stitches out I started to bleed at the end of the surgery site. But was able to put strips over the site. But the next day it broke open and I had to have another surgery. Then another surgery was done to close the second surgery. Two months later the pump had to come but they could not get the mesh out because of the fact it would impossible to get it out of me. So I came back to my pain doctor and he done the forth surgery to remove my mesh, they was not able to get it all and was told by the doctor the smell inside my stomach was almost to much for him to do the surgery Then two weeks later the doctor was able to put in my pump on the other side. This was the worst year in the last 34 years since the accident. I hope I never have to go threw this again. But the said I still could have problems down the road with the mesh they could not get. they new the mesh was a problem and never told me I should have the mesh out. And I’ve been threw heel and they should have make it right.

  15. Barbara Reply

    I am on my 3rd or 4th pump and am ready to have this one removed and not replaced. I have had it fail, had too many failed dye studies to count as well as so many surgeries I can’t remember.
    I AM TELLING ANYONE STRAIGHT UP-NO MATTER HOW BAD YOUR PAID IS, DO NOT AND I MEAN DO NOT CONSIDER A Medtronic infusion pump. Ity will destroy your life and you become addicted to drugs.
    I had a back surgery and the surgeon made a mistake which required a different surgeon try to correct the mistake and it wasn’t possible. My original surgeon knew he made a mistake and put me on oxtcontin. I was on that so long I became addicted. I went to my general doctor and told him i knew i was addicted and i needed to go to treatment. I spent 3 or 4 days inpatient and got thru that hell. After that I was suggested I consider a medtronic pump. So after thinking about it for several months I went in to M.A.P.S. and told them my history. I told hem specifically i went to treatment and don’t want anything I could become addicted to. I was assures the medicine drips into my spine and because its intrathecal, I wouldn’t become addicted. BIG EFFIN LIE. I am totally addicted.
    I haven’t even mentioned the horrible metallic taste in my mouth I can’t stand and then everything smells horrible. I have lost 5 pounds in 5 days now because i can barely eat or drink anything. even water smells terrible.
    I have had so many problems that im done. I had the most recent surgery back in April to move it from the front to the back because in front it kept flipping and kinks the catheter. Now in back it started flipping yet again. I have decided that I’m done with it. I have had 4 surgeries in the last year alone, to fix malfunctions and things I feel are directly the doctors fault. I am also looking for an attorney. I think it’s time to put medtronic and M.A.P.S. in their place and make them pay for all the hell I have gone thru because of them. Everytime I have had surgery to fix their mistakes my insurance has to pay the bill. When I was going thru withdrawl hell, the oxycontin was NOT covered by my insurance and that was over $30 PER PILL and thats beyond acceptable. I know im about to lose my job because of the constant surgeries and time off. It will be the 3rd job I lost because of the frequent time off.
    I need a good attorney, it’s time to sue both Medtronic and M.A.P.S. before it literally kills me.

  16. Pamela Reply

    I have had the synchroMedII I am on a very low dose very thins they try to increase it my heart rate goes down and I have shortness of breath.i was doing pretty good until Jan I was in an accident . I acused my nurse of turning it down I had like some one was shocking me and the pain is so bad I can’t walk a lot again weight Bering kills me my lower back and running down the front of my left leg my dr is runing test on me this month to see if the tubing has moved . I am wanting it out I have always been a little scared of it
    M

  17. KENNETH Reply

    After reading all of the above comments, my heart goes out to everyone who has suffered. My name is Shirley and Kenneth is my husband. He is on his third pump and it have been a living hell since it was placed September 11, 2013. Here it is Aug. 2016 and he is still going through the pain, overdosing and withdrawal systems. You never know what to expect from day to day. This week has been extremely hard on him, the ups and downs are nearly driving him crazy and I am right next to him. This affect the whole family in a way that no one can imagine. There has got to be someone out there that is willing to help take the burden away. This is cruel and-inhuman what people are going through and no one seems to care. Doctors think that you are craze and out of your mind when you complain. He was told at one time that if he complained too much they would discharge him from the clinic. What are you suppose to do, keep suffering with the pain, overdoses and withdrawals?

  18. Ry Reply

    A place to share concerns and support.

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