Medtronic SynchroMed II Pump Lawsuit Filed Over Malfunctions That Resulted in Drug Overdoses

A product liability lawsuit has been filed over problems with the Medtronic Synchromed II infusion pump, indicating the device was defectively designed and resulted in repeated overdoses of powerful painkillers.

Nancy Kilmer filed the complaint (PDF) in the U.S. District Court for the Eastern District of California on September 8, pursuing claims against Medtronic for manufacturing and selling and unreasonably dangerous drug infusion pump system.

The Medtronic SynchroMed II is a small, battery powered implantable pump used to deliver prescription drugs to patients through a catheter, specifically into the spinal fluid to treat chronic pain and severe muscle spasticity in patients who are not responsive to other, less invasive, forms of drug therapies or treatments.

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Over-infusion from Medtronic Synchromed II pumps occur when more of the drug is delivered than programmed, which may or may not result in symptoms of a drug overdose, and could result in withdrawal symptoms if the drug reservoir is emptied prematurely due to overinfusion events. However, patients are often unaware their device is giving them too much of a drug until they go to refill the pump reservoir and find it lower than expected.

In 2016 Medtronic issued an Urgent Field Safety Notice indicating it was aware of more than 100 adverse events related to likely over-infusion events linked to the SynchroMed II.

According to the Medtronic Synchromed II lawsuit, Kilmer had one of the infusion pumps implanted in April 2006, for the treatment of pain caused by injuries she suffered in a 1998 fall that left her with chronic pain. Her pump was used to deliver powerful opioid doses, like hydromorphome and clonidine, when it malfunctioned in 2008, causing her to vomit and suffer symptoms of drug withdrawal.

Kilmer had that first pump replaced in 2012. However, the next SynchroMed II pump implanted also experienced problems which resulted in overdose-like symptoms in 2014 and 2018, during pump refill procedures, resulting in brief hospitalizations. She again had the SynchroMed II replaced in December 2018, with yet another Medtronic SynchroMed II pump.

The third pump was used to deliver Dilaudid (hydromorphone), which is a particularly powerful opioid pain reliever. Just months later, in March 2019, it overdosed her again during a refill procedure.

“On or about March 22, 2019, a Medtronic representative spoke with Ms. Kilmer via telephone, and advised her that Medtronic was aware of pump overdoses occurring at refill procedures and that Medtronic did not know why they were happening,” the lawsuit states. “In or about July 2019, displeased with the performance of the SynchroMed II after having suffered repeated overdoses, but still wanting to treat her pain and reduce or eliminate the need for oral medication, Ms. Kilmer was persuaded to have her SynchroMed II pump replaced with a Flowonix-brand pump.”

A History of Medtronic SynchroMed II Problems

The Medtronic SynchroMed II Infusion Pump line has been plagued with problems over the last several of years, which have caused many users to suffer severe and potentially life-threatening health issues.

In February 2011, the FDA declared a Class I Medtronic Synchromed pump recall following reports doctors were accidentally injecting drugs directly into patients’ subcutaneous tissues while attempting to refill the devices. These “pocket fills” resulted in at least eight deaths and 270 injuries requiring medical intervention.

In September 2011, a Synchromed II battery recall was announced after the company received reports of batteries becoming covered with a thin film and failing. The FDA classified that as a Class I recall as well. Class I medical device recall classifications mean that the FDA believes the device has a reasonable likelihood of causing severe injury or death.

In July 2012, the FDA sent a warning letter to Medtronic over the infusion pumps, ordering the company to put in place a plan to deal with reported failure problems. The FDA had received 567 complaints about motor corrosion in the SynchroMed II pump between then and October 2007. The corrosion caused gears to lose teeth, which lead to the motor seizing up.

The FDA finally entered into a consent decree with Medtronic over the repeated errors and manufacturing problems in April 2015, which required the company to cease manufacturing, designing and distribution of new Medtronic Syncromed II infusion pumps, except in cases where a doctor determined it was medically necessary for a patient’s treatment.

Similar problems have plagued Medtronic’s MiniMed Infusion Pump, which is used to deliver insulin. A number of Medtronic infusion set lawsuits have been filed on behalf of patients who suffered serious injury or death when they received too much or too little insulin. Each of the plaintiffs raise similar claims, indicating they were prescribed and used Medtronic’s 600 series of insulin infusion pumps to automatically deliver insulin into their bodies for the treatment of diabetes.

As Medtronic Minimed pump recall lawyers continue to review and file claims, it is expected that hundreds of lawsuits may be filed in the coming months and years, as individual realize that insulin pump malfunctions may have been caused by known defects associated with the device.

20 Comments

  • LindaAugust 8, 2023 at 10:15 am

    I posted a comment 12-22 Can't get anyone to listen to me..

  • kennethMarch 21, 2023 at 10:23 am

    I was recommended to have the back of it pumped for my spasticity from multiple sclerosis I was led to believe it would be tested to see if I would have good results when they tested me I told them I didn't have any effect on my spasticity at all I was told that was common and they could adjust this after it was implanted believing this I went and had the operation done instead of placing the pump[Show More]I was recommended to have the back of it pumped for my spasticity from multiple sclerosis I was led to believe it would be tested to see if I would have good results when they tested me I told them I didn't have any effect on my spasticity at all I was told that was common and they could adjust this after it was implanted believing this I went and had the operation done instead of placing the pump underneath my skin in my stomach it was placed in my back it was very painful for a long time it was placed in a very bad spot preventing me from sleeping well and sitting comfortably and they did not have my permission to place it there I was also told I was an imagining everything I was able to walk before the operation I was not able to walk after the operation again the doctor refused to give me rehab at home Rehabilitation or medical services it became impossible to get to his office since I can no longer walk or take care of myself I had to have my sister stay with me who by the way is a nurse to take care of me to this day I was bedridden please help me if you can

  • StevenJanuary 10, 2023 at 12:13 am

    I had a DR. re-place my 1st pump with a pump that was recalled. The Dr's office nor Medtronic didn't inform me that the device they were in-planting in me was covered under this re-call. I have had so many problems around the pump. It feels like fluid is sloshing around, subcutaneous around the area of the pump. The scar tissue is quite pronounced. I have diverticulitis and the pain around the[Show More]I had a DR. re-place my 1st pump with a pump that was recalled. The Dr's office nor Medtronic didn't inform me that the device they were in-planting in me was covered under this re-call. I have had so many problems around the pump. It feels like fluid is sloshing around, subcutaneous around the area of the pump. The scar tissue is quite pronounced. I have diverticulitis and the pain around the pump is unbearable. I had an MRI that went poorly. It was vibrating during the procedure, and I was screaming from the pain. My DR told me that the device was made from Titanium and couldn't vibrate during an MRI. My wife is ready to leave me as this hasn't been much fun for her.

  • TamaraJanuary 1, 2023 at 12:43 pm

    On on 2nd pump since 18 had 2nd replaced in Oct 22 and now the catheter is leaking

  • ReyDecember 26, 2022 at 1:56 pm

    My son has A Medtronic syndromed 11 Pump Implant date feb2016 serial # NGV514188H model #8637-40 In Lubbock Texas Doctor withdrew treatment he's in A Nursing home in El Paso Texas can't get any information.. currently going t withdrawals from medication.. pentax health manages the pump they took the medication out they never called me

  • JosephApril 16, 2022 at 10:56 pm

    Hi all I am on my Second Medtronic Pain Pump now! I had the First one for almost 8Yrs. I was never told about Recalls or Warnings on either one. I’m wondering if anyone else with the Pumpbhas had any problems with their ability to Think and remember things since they got the Pump? The first 3 Months I was on the Pump, I couldn’t make sense of anything. I couldn’t Think straight. It ended up caus[Show More]Hi all I am on my Second Medtronic Pain Pump now! I had the First one for almost 8Yrs. I was never told about Recalls or Warnings on either one. I’m wondering if anyone else with the Pumpbhas had any problems with their ability to Think and remember things since they got the Pump? The first 3 Months I was on the Pump, I couldn’t make sense of anything. I couldn’t Think straight. It ended up causing a Divorce and I accidentally Shot myself when my Dog alerted on someone sneaking around my House! I have Hunted my entire Life and know Firearm Safety! I don’t even know for sure how it happened. It took a while to get my Mind right and I still am dealing with Memory problems! My Pain is worse than it was before I got the Pump! I have been pretty much in Hell since getting the Pump. I’m scared to have it removed because if I’m in this much Pain, I don’t know how much Pain I will be without it. My first Dr. I was assigned to for the Pump was put in Prison for over subscribing Medications and Making the Medicine in the Pump to strong? He actually had Patients Dying. Has anyone else had these problems with the Pump effecting your Mind? It was only about the first 6-8 Months it effected me like that. I guess you get used to the Medicine after the First part of the First Year. What’s the worst part is I lost my Family and I’m pretty much alone now living with unbearable Pain. I hope everyone else with Chronic Pain is doing better than me. By the way I have 4 Fusions in my Neck and 2 Lumbar Fusions with I lost count on how many Surgeries. Screws coming loose, Failed Fusions, everything you can imagine going wrong. I had another MRI and was told I need 3 more Lumbar Fusions!!!! Thanks

  • TerriFebruary 15, 2022 at 6:37 pm

    For about 3 months more or less I've been experiencing withdrawal symptoms especially if I do not do a bolus for more than 12 hours. I've told my Dr. about this and was made to feel like I'm imagining this. I have an appointment in a few days and will bring up this issue again. If nothing is done then I might consider removing the pump. I will update

  • RobinOctober 26, 2021 at 3:13 pm

    Had a medtronics pain pump malfunction on me almost cost me my life need an attorney

  • LisaSeptember 9, 2021 at 5:14 pm

    I have one now. I have had 2 altogether for years. I am terrified everyday that mine will stop again. This has happened to me twice now. I have gone I to severe withdrawal. When I called my Dr he claimed he didn't work after hours or on the weekend. It was a Friday night. He made me suffer til Monday and I had to drive a state over to see him at another place . He was mean didn't care what was h[Show More]I have one now. I have had 2 altogether for years. I am terrified everyday that mine will stop again. This has happened to me twice now. I have gone I to severe withdrawal. When I called my Dr he claimed he didn't work after hours or on the weekend. It was a Friday night. He made me suffer til Monday and I had to drive a state over to see him at another place . He was mean didn't care what was happening to me. I tore my house up I wanted to kill myself because the withdrawal was so horrible. Then I had them let it run dry later on after that happened. Tell me to go to er and they wouldn't help me at all .

  • LeeAugust 16, 2021 at 4:07 pm

    I am saddened to read about people having issues, some even life-threatening, due to the Medtronic Pain Pump implanted in your body. I hope all of you get relief from the pain and suffering you are wanting. How disheartening is it to listen to our medical specialists, only to be led astray? I had L4-L5 fusion in 1987 and again in 1989 after a fall that dislodged the first fusion. I was externally[Show More]I am saddened to read about people having issues, some even life-threatening, due to the Medtronic Pain Pump implanted in your body. I hope all of you get relief from the pain and suffering you are wanting. How disheartening is it to listen to our medical specialists, only to be led astray? I had L4-L5 fusion in 1987 and again in 1989 after a fall that dislodged the first fusion. I was externally fortunate to get eighteen years of relief from the pain and suffering I was experiencing pre-surgery. Considering my Family Practice Doctor told me studies had shown that back surgery on a whole average only two years of comfort. In 2008 I hurt myself trimming bushes. The pain started minimally but progressed quickly. I went from Hydros for the pain to morphine (pills), Oxy 10’s, ’20s, then ‘30s, and taking four every 8 hours. Finally, my Doc put me on the fentanyl patch, starting with 25 mcg/h, then 50,75 and ended up wearing 3 x 100 mcg/h patches by 2012. I was in a good place pain-wise until 2016, when the feds started fucking with opiates. It was easier for the government to make opiates hard to get for legit pain patients thinking that addicts will have problems obtaining them too. Bullshit!! In 2017 I ended up having a Flowonix Pump implanted. Post-surgery sucked. I was in pain for weeks. Now, however, I am at a good place again, and I sincerely hope you all get to that point someday.

  • MelissaAugust 3, 2021 at 5:48 pm

    DO NOT GET A PAIN PUMP if you think you will live longer than one year. I wish someone would have warned me before I had a Medtronic Pain Pump II inserted into my spine. I have since had it removed and after coming so close to death several times, almost wishing for death because of the symptoms that this caused me, I am now starting to feel more normal (it's been over 18 months since it was rem[Show More]DO NOT GET A PAIN PUMP if you think you will live longer than one year. I wish someone would have warned me before I had a Medtronic Pain Pump II inserted into my spine. I have since had it removed and after coming so close to death several times, almost wishing for death because of the symptoms that this caused me, I am now starting to feel more normal (it's been over 18 months since it was removed). I immediately had relief as soon as I had the medication in the pump lowered 50% each time, every 3 to 5 days. I would go through terrible withdrawals each time not realizing that the symptoms that I had been going through for several years were "withdrawal symptoms". Every time I would end up in the ER, having horrible symptoms and very high BP, etc. for no apparent reason, I realized after having the medication lowered that it was withdrawals. I gained over 80 pounds and I could not eat! I have lost all of the weight after having it removed. This is just a snapshot of how horrible the symptoms were to me. No matter how much pain I am in, I would NEVER get another pain pump! I took 7 years of life away completely. I feel fortunate that I am now capable of living again. I am one of the lucky ones! I made the doctor remove it against his will!

  • StevenJuly 25, 2021 at 4:43 am

    I had Flowonix Prometra 11 Implanted about 6yrs ago best thing I ever did.Has given me ability to do alot more.I have had 13 Spinal Surgeries starting at 28 to 51 .I am fused from C2-T8 and fro T11-S1 so most of my spine.I have had multiple MRI since it was Implanted they have always had a Nurse meet me at imaging and remove Medicine from my Pump then refill after MRI.I decided to get pump when CD[Show More]I had Flowonix Prometra 11 Implanted about 6yrs ago best thing I ever did.Has given me ability to do alot more.I have had 13 Spinal Surgeries starting at 28 to 51 .I am fused from C2-T8 and fro T11-S1 so most of my spine.I have had multiple MRI since it was Implanted they have always had a Nurse meet me at imaging and remove Medicine from my Pump then refill after MRI.I decided to get pump when CDC started cracking down on Narcotics.But going on Pump since dose is so small I felt clear headed and like I wasn't on any Narcotics anymore which was nice actually.

  • jeffreyJuly 15, 2021 at 4:40 am

    my name is jeff i had a medtronics pump put in back in july of 2012 after many stays in hospital come to find out same year /day / month the pump was put in me and many others the ceo of medtronics was sent criminal warning letter that the pumps where defective in many ways this was the start of my and gods battle with pain pumps then in around 2016 it was replaced with a flowonixs pain pump whic[Show More]my name is jeff i had a medtronics pump put in back in july of 2012 after many stays in hospital come to find out same year /day / month the pump was put in me and many others the ceo of medtronics was sent criminal warning letter that the pumps where defective in many ways this was the start of my and gods battle with pain pumps then in around 2016 it was replaced with a flowonixs pain pump which thy knew just overdosed a women while in hospital care cause scan open vale and it overdosed here lots more to come all backed digital and recordings im done setting back before i leave this world the truth will come out i know god has his hand on me to let me make it thru what i have been bleesed to still be here to tell my story lots more to come all backed in many ways.

  • DeboraJuly 11, 2021 at 2:49 pm

    I had a Flowonix Prometra I pump put in 09/2013. I started having health problems not long after pump was placed in me but no doctor related it to the pain pump. After over 6 years of having attacks (which were withdrawals) multiple doctor and hospital visits, test after tests that nothing showed up, dangerously high BP and so sick I thought I’d die, well, my flowonix pain pump just stopped workin[Show More]I had a Flowonix Prometra I pump put in 09/2013. I started having health problems not long after pump was placed in me but no doctor related it to the pain pump. After over 6 years of having attacks (which were withdrawals) multiple doctor and hospital visits, test after tests that nothing showed up, dangerously high BP and so sick I thought I’d die, well, my flowonix pain pump just stopped working with no warning! It also has 2 alarms but no alarm went off! I have been through Hell since I had this pain pump put in!! I trusted the doctors and this pump when they said this was the best way to deal with my back pain plus help me have a better life controlling my pain; they were so wrong!! This has been a nightmare and I’m so angry!! The withdrawals were life-threatening with BP as high as 225/120 and so sick I thought I’d die!! So now it’s been over 5 weeks since pump totally quit working and my doctor has had to lower my BP meds in half and I’m slowly feeling normal again except for some side effects. I just don’t know where to turn or what to do about what I have been through? Has anyone reading this had a Flowonix Prometra l pain pump that malfunctioned or quit working? I know they now have Prometra ll but I have Prometra l from 2013. Thank you to anyone that responds!!

  • Lisa AnnJune 7, 2021 at 10:53 pm

    I have the device implanted to I have now gotten a possibility of tumor extreme pain where my catheter is saw my dr today I have to go to er now

  • TimMarch 18, 2021 at 6:26 pm

    I've basically been sick for 7 years since implanted. Major digestive issues any many more side effects. Have had meds and dosages switched many times, Dr's too. Weaning off for removal now. Worst decision of my life was getting this in me.

  • KarenMarch 14, 2021 at 3:14 pm

    I would like advice as to where to go as well have a product liability suit with the Synchromed to the serial number has already been placed as one in the class action lawsuit.. I’ve had multiple seizures from withdrawal and also I believe the doctor that put it in was already notified that it was a Defective pump and 2016 before he placed it, and is now lying about the fact that he was the one th[Show More]I would like advice as to where to go as well have a product liability suit with the Synchromed to the serial number has already been placed as one in the class action lawsuit.. I’ve had multiple seizures from withdrawal and also I believe the doctor that put it in was already notified that it was a Defective pump and 2016 before he placed it, and is now lying about the fact that he was the one that placed it in order to get it removed I contacted him as med Tronic is the one that advises us to have it out by the doctor that place in us. That’s all she has been lying to me ever since I contacted him about the device manufacture issues and therefore I am terrified to go under the knife with him to have him Remove it as he knows there’s many lawsuits against him i’m I’m sure he will not work hard to revive me if something goes south during the taking out of the device. Also I’ve been informed that I need to get another personal injury lawyer for all of the doctors that ever touched my Medtronic Synchromed II Baclofen infusion pump as well.

  • JohnFebruary 11, 2021 at 9:20 am

    I have a potential product liability and malpractice lawsuit regarding this devoce and would like info on where to go for help.

  • SharonFebruary 9, 2021 at 3:36 am

    I had one installed September 2019 and it has not worked right since they had to change out the BOLUS box 2 x in the 1st 3 months I had it in me.

  • MargieNovember 17, 2020 at 9:26 pm

    I would love to get help with this pump inside me

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