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.
But it does give the FDA strict oversight over design changes planned for the SynchroMed pump, as well as changes in the company's quality-control systems in manufacturing. Medtronic will have to hire an outside expert to validate plans to correct the problems cited by the FDA, and then submit regular audit reports on its new processes. The FDA will also make surprise visits to inspect the plant.
Company executives said in a statement that they're serious about addressing the issues and returning to normal manufacturing of the pump.
"We are committed to the highest level of quality, and have pursued significant efforts in recent years to enhance the performance of the pump and to address the FDA's expectations," Tefft said in a statement. "We are confident that our efforts to date will contribute to the timely and thorough completion of these activities while preserving access to this important therapy."
Violations and deaths
Many patients who need the device have symptoms caused by multiple sclerosis, spinal cord injuries, cerebral palsy or strokes. Under the agreement, patients will need signed forms indicating that they understand the FDA's findings and that their physician believes the benefits of the therapy outweigh the risks.
In June 2013, Medtronic acknowledged that 14 deaths had been associated with SynchroMed pumps since 1996. They included two people whose devices had blocks in the tube that delivers pain medication, and 11 cases in which the drugs were inadvertently injected into tissue around the pump rather than into its reservoir. One death was connected to a short-circuit in the device.
Word of the deaths came after the company told doctors about potential problems with the pump and issued special instructions for its use. The FDA later classified that communication as a Class I recall, which is the most critical type.
Monday's FDA announcement said that between 2006 and 2013, five inspections at the company's neuromodulation plant in Columbia Heights turned up violations of quality-control rules, resulting in three warning letters disclosing major violations in how the pumps are designed and made.
"Defendants promised corrections at the conclusion of each inspection," the FDA complaint says.
The violations included problems with how the company identified, investigated and corrected quality problems with the device, and its failure to document design changes. The company also failed to ensure the finished products met design specifications, the FDA said.
In 2012, the FDA warned the company it had failed to address numerous problems turned up in a 2007 inspection. It told the company that a complaint like the one sought in court on Monday could be filed if Medtronic didn't address the problems.
Joe Carlson • 612-673-4779
