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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