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Medtronic Synchromed II Infusion Pump Recall: Defective Batteries

  • Written by: Staff Writers
  • 20 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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20 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.

  19. Douglas Reply

    Well, the things you think would never come true! I as well this weekend had the critical alarm go off after 1800 on Friday…not one rep to be found (Medtronic) because they get the weekend off…after 3 hours on the web I found out it was a critical alarm …finally got one rep I found online who said it may be critical she was unsure…after 4 hours of trying to find anything the Doc found a rep…I was in complete withdraw by 11am Saturday in er trying to push the morphine to get me stable….painful, frightening for my entire family, nurses, and docs I am sure…took forever to get out of withdraws put me in pain I never wanted…and now in constant pain because they could only do so much at ER…doc gives me oral, has not helped yet going into complete pain mode, feel like I aged 40 years in a weekend…then…then…to get the pump replaced…I have to play …You have to be seen before we can get you an op date….so extending pain for days if not weeks….I served 21 years military, did what was needed for my country and I cant get pain relief from the damages of my service connected disabilities…I have again been spit on by the money train of greed by our freaking health care!

  20. Douglas Reply

    New…tried to kill me twice in a week…..pump rebooted without warning.

    First…Implant went well, I am home and more angry then when this started, 10:33 pm, Monday, 21 Sept, 2020.

    Douglas C Scalf, US Army, Retired 2003

    I am going to tell you what happened, I hope to save lives by doing this. Because now I have a deep concern about actions, steps, safety regulations, and since I was in the military I will even give you a possible how to avoid this in the future…because I was trained to take on problems, find the solution and then attack the situation or enemy with the knowledge and skills I have (true story).

    You know I spent 21 years in the Army, Mostly at Fort Bragg, NC, Infantry, Airborne for most of my young career until a bad jump took me down at year 12 sending me to an administrative job for the rest of my career and the fact that I survived, physically and mentally and moved on to have a somewhat normal life I think is kind of cool.

    I new when I was in the military what my job was, get called to war, do special missions, protect my soldiers, survive…I never thought my injuries and the treatment of them may have taken me out at age 57.

    You may be saying, Drama….no, anger. I hope you are as angry when I am done and read and learn from what may have happened, maybe stop ignoring folks (Statements read about others issues from folks with same model I have being told they are imagining things, they are paranoid) who are only trying to tell you…something is wrong! Get off your ego and fix this before you kill someone!

    Since 2014 I have complained to my Primary Care and to my Pain Mgt Doctor, Issues I have been having about my health, I have had blood test after blood test, drugs withdrawn from pump match what they should, changed out the catheter because of my complaints of feeling dizzy, every month getting thrown into what looked and felt like full blown drug withdraw stuck in my room 2 days eating and drinking nothing and to weak to do anything, changing clothes and sheets every few hours to try and stay warm because of the sweats. By day 3 my wife would then get me in a car and take me to the ER and we would explain to them the doctors have no clue, we (my wife and I) think it has something to do with the pump…and then I would be asked why, we would explain and I even informed them I came off every drug I ever had with the doctors approval, we put me back on only the things need Acid Reflux, Cialis, Testosterone shots, PUMP…this is how bad it got, I could not understand why my body would do this, why the doctors could not find the issues. I have had other issue, walking…I feel as I am drunk after a few meters…my head not feeling like it should and taking nothing that could explain why these things are happening…and then I read others postings, only after my fun day with full blown withdraw in the ER trying not to knock my head in the wall from the spasms, twitching like a chicken with its head cut off, bones itching from the inside (not the fun tickle, the tickle that hurts) and you cant make it stop, you cant touch it…. I can see how in the old days this would drive folks insane.

    Other then that…why am I so mad, why am I angry…?

    Your pump stopped on Friday…withdraw Saturday and pumped me with the safe amount enough to get me out of withdraw and yet not enough to stop all the spasms…Saturday night, went on drug plan until pump could be replaced… without any knowledge of your staff or my doctors…THE PUMP REBOOTS ITSELF Sunday (we found out today, a week later)! I am on a increased oral med to stop my pain and manage the withdraw….do you know why I felt stupid, slur words, had to walk assisted after sitting down, felt unlike me? Because I was overdosing myself…coming out of a severe withdrawal…after Sunday until surgery today I WAS SELF OVERDOASING because your machine gave a critical shut down…all of us (Pain Doc, PC Doc, ER Doc, me) did not have this information that this may happen…except you! And while every one tried to get this surgery going as fast as they could have…with the information that the pump may come back at anytime unknowingly all concerned may have rushed the surgery to prevent this exact issue to happen! But, my folks did not have this information.

    I had been on the pump for years, I thought because of the withdraw and the fact I was taking oral meds instead of the drip, this was the way I was suppose to feel…I am not a doctor. Now, I truly think you are lucky (if this only ever happened to me) because I am 100% disabled, I had to change my life style, I have to stay fit or my pain will come at me like a sledge hammer, my joints, my body…over 150 jumps and over 80% of them combat load. With the fact I do not drink, I try to stay fit…this is why my 173lb body at 5 foot 9…fought off what could have been a very bad situation…lets say if I was already overweight and had heart issues…you would have killed me.

    My heart issue, Wolff-Parkinson-White Syndrome…. Diagnosed my last hip replacement and tried to have it fixed and they could not recreate at the time of the procedure…anyone with heart issues, withdrawal or overdose…will have issues…but to do this to me all in a week, do you have a hit on me? Do you want me dead?

    To prevent death or this issue;

    The fix is very easy…on the card that you send us you have a 800 number that goes to a live person 24/7…someone who instructs them (us) what to do, give us the facts and then your rep goes to the hospital and puts the machine on, then confirms all and then at this point you either give the patience a machine to check every 12 hours until surgery and tell them (us) to inform you if the unit reboots to make a new drug plan/modify and allow no overdose ……….or not as cost effective, you create a machine for your patients you give to them incase of emergency, limited functions, something that reads the error and then spits out a number to call to put a plan in place………………………………………………………………………………………………..not let me call your doctor and see what he says (That’s been done, he knows, your telling him…cut out the middle man!) not make the patient search on the web for 3 hours to finally find a number after calling every Medtronic in and out of the area just to get one simple question answered, WHAT IS THIS ALARM! What should I do! Because you know what happens when you call 911 and say your tummy is beeping and you don’t know why, that will not fly. Going to an ER with the beep and let them look at you and say, unsure as well and you do not seem to be in withdraw. I suppose you can call your provider, to get the same answer as all above….I lived it…that is how it happened….plan must be in place, or folks will die.

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