Medtronic advises physicians on pump-refill errors

Medtronic, the Fridley-based medical device manufacturer, says eight deaths have been reported in connection to mistakes in refilling its Synchromed implantable infusion pumps.

The devices are about the size of hockey puck and are implanted in the abdomen. A tube guides medication to a patient's spine.

The pumps can deliver pain medication, chemotherapy or drugs that treat muscle tightening resulting from a stroke or other medical condition.

Medtronic says the deaths, as well as 270 serious injuries, occurred from May 1996 through September 2010. The problem occurs when a physician tries to restock the pump with medication, which is done by injection through the skin.

If the needle isn't properly seated in a receptacle on the device, the doctor can deliver an overdose or underdose of medication.

Medtronic spokeswoman Cindy Resman said the company sent urgent medical device correction letters to physicians last month, giving them new guidance about making sure the pumps are filled properly.

"This is one of the areas we watch," she said. "And we saw that rate of occurrence -- 0.01 percent -- and recognized that if we could provide some additional information that it would help physicians make sure they're doing refills appropriately."

That error rate works out to one botched refill once every 10,000 times.

Medtronic said the U.S. Food and Drug Administration has classified the instruction changes for the pumps as a Class 1 recall. The devices are not being taken off the market, but it says the FDA believes patients with the devices could suffer serious harm or death.

Medtronic, however, said there are no actions recommended for patients or physicians other than to follow updated guidance about refilling the pumps.

Asked if the problem lies with Medtronic or doctors refilling the device, Resman said this has more to do with providing "additional insights."

"To make sure that physicians have more detail in terms of steps," she said. "And it has to do with visual and tactile assessment that can be done throughout the refill procedure to make sure it's being done appropriately."

The devices have been subject to at least two previous FDA recalls since 2006. There have been problems with catheters coming loose and motor pumps stalling. Both problems can be fatal.

Diana Zuckerman, who heads the National Research Center for Women & Families, said the group has advocated for stiffer approval standards for medical devices.

Zuckerman said it appears the infusion pumps underwent the FDA's pre-market approval process, the agency's most stringent review. Patients should look for physicians well-experienced in using the pumps, she said.

"It sounds to me that if the person already has the device and they're fine, there's nothing to worry about at all," she said. "It sounds to me like the problem is if they're going to have it, to make sure they find a physician who has used this many, many times before and not had problems in using it."

Zuckerman said the FDA prefers not to mandate physicians receive training to use a device, but she expects such a requirement could be coming for the Medtronic infusion pumps if the additional instructional guidance doesn't end the errors.

"Sometimes they do have to do that in order to protect patients and save lives," she said. "My assumption is that if this first step doesn't work, then the FDA would either require special training for the use of this product or take it off the market altogether."

Industry analysts don't see the issue with the pumps affecting Medtronic much financially.

"For a company this large with massive exposure in cardiology and ICDS and stents and surgery and orthopedics, diabetes care, this is just not that big of a business for them," said Dave Heupel with Thrivent Financial for Lutherans.

Heupel estimates the pumps account for less than one percent of Medtronic's some $16 billion in annual sales. Medtronic stock was up 1.5 percent today to close at $40.20.