Medtronic will stop making an implantable pump system, after federal regulators claimed the company failed to fix problems with its manufacturing.
In a deal announced Monday, the Food and Drug Administration said Medtronic was warned three times about "major violations" regarding the manufacturing of its Synchromed II Implantable Infusion Pump Systems from 2006 to 2013.
The FDA cited Medtronic for "repeatedly failing to correct" those violations, including:
- Not having a process for identifying and correcting problems with the device
- Failing to record needed design changes
- Not ensuring the final product met design specifications
The pump device is implanted, and used to send medicine directly to the fluid around the spinal cord, Reuters says. It's used to treat patients with cancer, chronic pain and other issues.
According to the Star Tribune, Medtronic says 14 people have died as a result of complications with the device.
The FDA says the device would sometimes deliver too much or not enough of the medication, or can deliver the treatment later than intended.
Under the agreement – which is called a consent decree – the only time one of the pump systems can be manufactured and issued is if a doctor deems it "medically necessary" for a patient's treatment, the FDA says.
"We take our responsibility to ensure continued support for clinicians and their patients who rely on this important treatment option very seriously, and we are committed to working collaboratively with the FDA to address their expectations as quickly as possible," said Julie Foster, who works in Medtronic's Neuromodulation business.
In the meantime, Medtronic has to hire a third-party expert to help address those purported violations, and after some time could get the FDA's permission to once again manufacture the pump.
The devices aren't being recalled, but the FDA says anyone with a Synchromed II Implantable Infusion Pump System should maintain regular appointments with their doctor. If there is a change or return of symptoms, or if a device alarm going, they should contact their physician right away.
The Star Tribune says the company doesn't admit any fault or wrongdoing by agreeing to the terms.
A judge still has to give final approval to the deal.