Medtronic PLC has agreed to stop selling a pain-medication pump linked to patient deaths except in rare cases, after regulators accused the company of failing to address recurring problems with how the device is manufactured at a plant in Columbia Heights.
The implantable device, called the SynchroMed II infusion system, delivers tiny doses of medication directly into the spines of patients with chronic pain from conditions like cerebral palsy, multiple sclerosis and cancer. The company has said 14 patients have died from complications associated with using the implantable device.
Monday's agreement with the Food and Drug Administration means the company can continue to sell the pump only in what the agency called "very limited" cases in which the patients understand the risks and physicians determine there is medical need. The agreement was filed in federal court along with a 10-page complaint that lays out the allegations.
"Defendants are well aware that their practices violate the Act," the complaint says, referring to the Food, Drug, and Cosmetic Act that gives the FDA the power to regulate quality control in how medical devices are designed and manufactured. "FDA has repeatedly warned defendants, both orally and in writing, about their violative conduct, and has emphasized the importance the defendants' compliance with the Act."
Problems cited years ago
Physicians have long known about issues with the device, but they say there are few alternatives on the market. The FDA said Monday that problems with how the device is made can cause it to deliver too much or too little medication, or to delay therapy.
Medtronic, which moved its headquarters from Fridley to Ireland in January, has sold more than 230,000 of the devices worldwide since the first version was brought to market more than 25 years ago. It's not clear what impact the legal agreement will have on sales of the device, which securities filings say is an important revenue driver in Medtronic's $1.9 billion neuromodulation division.
Neither Medtronic nor its chief executive, Omar Ishrak, admitted any wrongdoing or liability in signing the agreement. The Food and Drug Administration's complaint accuses the company and Ishrak, along with division President Thomas Tefft, of not addressing problems that were cited in inspections going back almost a decade.
The agreement, which still requires approval from a federal judge, doesn't require Medtronic to retrieve any of the implantable devices from patients or share any new safety information about its uses and limitations.