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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.