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Doctors and nurses walking in hospital hallway, blurred motion.

A Georgia woman has filed a new Medtronic infusion pump lawsuit on behalf of her friend, who was severely injured in a car accident in 2011. Since then, she has been incapacitated and was relying on the infusion pump to deliver medication to control the muscle spasticity associated with her condition.

The plaintiff states that the pump malfunctioned, landing her friend in the hospital.

Medtronic Pump Used to Regularly Deliver Medication

The device at issue is the Medtronic SyncrhoMed II device, a programmable drug-infusion system implanted into the body. It includes the pump, which is connected to a thin, flexible catheter that is then attached to the body. The pump delivers the medication as needed according to the schedule and dose programmed into it.

The entire device is implanted and remains under the skin. A clinician measures a precise amount of medication and injects it into the pump’s reservoir fill port. The battery-powered electronics and motor gears deliver the programmed dose of medication through the catheter.

Plaintiff’s Medtronic Pump Malfunctions and Fails

According to the complaint, the plaintiff is a 32-year-old woman with a history of muscle spasticity in her upper extremities, lower extremity weakness, and a seizure disorder due to the traumatic brain injury.

To reduce the spasticity, the plaintiff was implanted with the Medtronic SynchroMed II device in June 2011. It was later replaced in June 2017 with an identical device. Unfortunately, this second device malfunctioned, eroding through the plaintiff’s skin. It had to be removed shortly after implantation.

Doctors implanted a third pump—the same kind—into the plaintiff in January 2018. It was supposed to deliver a programmed amount of medication into her spine. For several months, the plaintiff’s muscle spasms improved, but then at the end of October, she suffered a series of six seizures in a handful of days.

Her family took her to the hospital, where the doctors conducted an MRI. From October 2018 through December 2018, her spasticity worsened and she suffered from dramatic mood changes. In December 2018, her doctors concluded that her Medtronic SynchroMed II device had malfunctioned and failed, based on her presentation of symptoms of significant medication withdrawal, and the pump showing a motor stall.

Because of the pump’s failure, her doctors scheduled her for surgery to remove it. She underwent that surgery in January 2019. Because of the pump’s malfunction and failure, the plaintiff suffered significant pain and suffering mental anxiety and anguish, and had to undergo additional medical procedures to solve the problem.

Medtronic Pumps and Catheters Have a Long History of Recalls

The plaintiff states that during the time the plaintiff’s pump was being manufactured, the FDA conducted numerous inspections of Medtronic’s manufacturing and quality control facilities, discovering a multitude of significant violations of federal law governing the manufacturing and quality control of medical devices like SynchroMed II pump. The FDA issued several warnings dealing with these violations.

The FDA also issued at least 19 Class I and II recall for SynchroMed II pump models during the time the device was on the market, starting in 2004 and continuing through at least 2019. In the October 11, 2019 recall, the FDA noted a risk of the permanent motor stall, such as that which occurred in the plaintiff’s pump.

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