A recall of Medtronic drug pumps was named class-one by the Food and Drug Administration on Monday. According to the FDA, these are “the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” In this case, the threat is a failure of the pumps to deliver the drugs consumers use for chronic pain, spasms, and other ailments.The issue lies in a film that may form over the batteries of the pumps, impairing their function.
This recall affects models SynchroMed II implantable pumps 8637-20 and 8637-40. SynchroMed II pumps are designed to deliver morphine sulfate and ziconotide for chronic pain, intrathecal baclofen for spasms, and floxuridine and methotrexate for certain types of cancer: metastatic and primary. These models were distributed beginning in May 2004, and ceased on July 8, 2011, when Minneapolis’s Medtronic Inc. informed doctors and suppliers of the malfunction in an urgent letter. According to the Washington Post, Medtronic has since changed the design of their drug pumps in response to the problem.
The possibility of malfunction was first noted back in July of 2009, but it wasn’t until two years later that Medtronic grew seriously concerned, with at least 55 battery-related problems confirmed in the use of their pumps. Currently, there are nearly 140,000 of these models of pumps worldwide.
Since the pumps are implants, Medtronic is not recommending a universal removal of these models. Although the severity of the issue is valid, the relatively low occurrence of incident (about 0.04%) is not reason enough for such an extensive measure. The FDA warns that replacement surgery can be a risky procedure, so with a less than one percent chance of pump impairment, patients should instead simply stay aware.
Patients with a SynchroMed II pump of the applicable models can monitor the function of their pumps in two simple ways: noting their general state of well-being and listening for the pump’s malfunction alarm. If the applicable drug doesn’t seem to be working, or a patient is experiencing withdrawal symptoms from the drug, they should contact their doctor. The FDA’s information on the recall provides an example: “patients receiving intrathecal baclofen therapy for severe spasticity are at risk for baclofen withdrawal syndrome, which can lead to a life-threatening condition if not treated quickly and effectively.” The pump’s alarm may also indicate problems and should be investigated with medical attention. Patients should carry their medical information cards with them at all times, in the event a medical emergency arises.
Anyone with questions about their device can contact Medtronic Patient Services at 1-800-510-6735, Monday – Friday, 8 a.m. to 5 p.m. CDT.
