A medical device recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, or when it could be a risk to health. They do not always mean that you must stop using the product or return it to the company.
In most cases, a manufacturer or distributor recalls a medical device on its own. The FDA can require a company to recall a device if the company refuses to do it. But this is rare.
Doctors, patients say they intend to stick with Medtronic drug pump
- Article by: James Walsh
- Star Tribune
- June 27, 2013 - 9:15 PM
Medtronic Inc. said Thursday that 14 patients have died from complications associated with its SynchroMed implantable pump, which was formally recalled by the FDA on Wednesday. But with few alternatives available, doctors and patients said they will continue to use the device and tout its benefits.
“Most of my patients, if I told them I wanted to take their pump out because of potential problems, they would say ‘Leave it in until you know for sure,’ ” said Dr. Diane Chappuis of the Courage Kenny Rehabilitation Institute in Minneapolis. “That is not to say that some patients don’t have a problem or two with their pump. But most of our patients don’t have a problem.”
The SynchroMed pump is used to deliver drugs directly to the cerebral spinal fluid in patients with intractable pain or who have severe spasticity and for whom oral medication is ineffective.
On Wednesday, the Fridley-based company announced that it had issued special instructions and warnings to doctors earlier in June about potential problems with the pump — problems that the FDA then classified as a Class I recall, meaning “there is a reasonable probability that the use of [these products] will cause serious adverse health consequences or death.”
Of the 14 deaths associated with the device, Medtronic said Thursday that one was from Minnesota.
Still, doctors such Chappuis said physicians and patients are fully aware of the issues associated with the device — and will keep using it. Without the pump, the medicine would have to be taken orally or by injection, which can cause fatigue in patients because the medicine has to go through the entire body.
Medtronic also says it remains confident in the pump’s ability to deliver safe and effective therapy. More than 200,000 pumps have been implanted in patients worldwide and, according to the company’s data, more than 98 percent of pumps implanted three years ago still are working well. For pumps implanted six years ago, more than 94 percent are working “within specifications.”
“We also continuously monitor and share information with physicians when appropriate to ensure they have information to make clinical decisions about choice of therapy for their patients,” said Donna Marquard, a Medtronic spokeswoman.
For patients like Matthew Taylor, the benefits of the pumps far exceed the risks.
A year ago, when his pump stopped delivering the drug that loosened his muscles and allowed him to run, the Florida teen took it as a “bump in the road,” his mother, Kim, said Thursday. The positive impact on his life had been so great, that once the device’s problems were fixed, the Taylors haven’t bothered to worry.
“So far, so good,” Kim Taylor said. “Everything seems great.”
Still, there have been issues. In 2011, the FDA classified a battery problem with the pump as a recall. In August 2012, the FDA issued a warning letter to Medtronic, alleging that the medical technology giant had failed to address safety issues. The FDA said it had received complaints about corrosion.
Medtronic’s Marquard said the company is no longer distributing a previously designed catheter with the pump. But there are no limitations on the continued sale and use of the device, she said.
Since the product was approved decades ago, she added, Medtronic has worked with the FDA to share information about the approved uses of the device — and the risks. The company publishes a product performance report, which has been available on its website since 2008.
Medtronic issued instructions to doctors addressing the most recent list of problems earlier this month. The FDA on Wednesday classified that communication as a recall.
The first problem is something called the “priming bolus function,” which is used to quickly move medication from the pump reservoir to the tip of the catheter. Medtronic found that anytime the function is used with the pump, the drug mixes with the sterile water or spinal fluid already in the catheter, which can result in an overdose — or an underdose — of the drug. Medtronic said no patient deaths have been attributed to this problem.
The second problem is a potential electrical short circuit causing the motor to stall, leading to a loss of therapy — leading to one patient death, Medtronic said.
The third issue involves the pump’s catheter, and a risk of the catheter becoming blocked if not aligned correctly with where it connects to the pump. Medtronic said two patient deaths have been associated with that.
Finally, Medtronic on Wednesday announced a safety update to the pump’s refill procedure, which continues a 2011 recall. Medtronic said 11 patient deaths are associated with that. The update is intended to help health care professionals reduce the risk of accidentally injecting drugs into the area under a patient’s skin where the pump is implanted, instead of into the pump itself.
For all these potential troubles, it’s not unusual that a “recall” by the FDA doesn’t remove a product from the market. In fact, most FDA recalls are voluntary, requiring medical device companies to develop corrective action plans that outline steps to fix the problem. Those steps could include new labeling instructions for doctors, patient education efforts or tweaks to the design of the device.
Jeff Windau, an analyst with Edward Jones, said the drug pump business is not a huge share of Medtronic’s neuromodulation business, although the company is a market leader. As such, he said, he doesn’t expect the recall to have much impact on Medtronic’s bottom line. It would only become an issue if “doctors get concerned,” he said.
Chappuis seemed unfazed Thursday. Her program, part of Allina, works with about 200 patients in the Twin Cities. They have MS, spinal cord injuries or cerebral palsy, or have suffered strokes. They range in age from 18 to 80 and have found little relief from other therapies, she said. The pump, she said, is not perfect.
“It’s a medical device like any other medical device; it can fail,” she said. But over the years, problems have decreased and she has seen fewer complications.
“The patients are well-informed that these problems can happen and we tell them about its potential Achilles’ heels,” she said.
James Walsh • 612-673-7428
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