Medical device maker Medtronic revealed that 14 patients have died due to problems associated with its SynchroMed implantable drug pump. The revelations came only a day after the FDA announced that the pump would be recalled over safety concerns.
The SynchroMed pump exists to deliver powerful drugs directly into spinal fluid in patients with severe pain or who are unable to take oral medication. Medtronic, which is the largest heart device maker in the world, issued a notice to customers and doctors in early June about four flaws it had discovered in its SynchroMed Implantable Infusion System. The FDA reviewed these issues and determined and each flaw mentioned in the customer notifications were serious enough to qualify as a Class I recall.
According to Medtronic, two deaths were associated with a blockage in the tube that delivers medication from the pump, one death was related to a short-circuit of the pump and 11 others were because the pump mistakenly injected medicine into the tissue around the pump rather than into the tube where the medicine should instead be directed. The company said the deaths occurred over the past decade and a half.
Medtronic decided to come forward with the numbers after the FDA announced earlier this week that it would be issuing a Class I recall for the product. Such a recall is only issued in cases where there is a reasonable risk that use of the product will lead to serious injury or death. Due to the variety of problems associated with the device, Medtronic says its recommendations about what to do in the case of patients with the pumps will vary depending on the age of the implant and other factors. Patients are recommended to talk to their doctors about any concerns they may have with the product.
Unfortunately this is not the first time Medtronic has run into problems with its medical devices. Medtronic recalled two types of the pumps in December of 2012 after reports came out that they may fail to properly deliver medicines, potentially leading to a return of symptoms and even death. The concern identified then was a risk of stalling and not properly delivering medicines, particularly when the pumps were used with unapproved drugs.