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

  • Written by: Irvin Jackson
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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.

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.

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5 comments

  1. Margie Reply

    I would love to get help with this pump inside me

  2. Sharon Reply

    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.

  3. John Reply

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

  4. Karen Reply

    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.

  5. Tim Reply

    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.

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