Implantable infusion pumps are surgically placed under the skin to deliver medications and fluids to the body. In recent years, federal regulators have warned that these devices may malfunction when exposed to a Magnetic Resonance Imaging (MRI) environment. In 2015, the U.S. Food & Drug Administration (FDA) also ordered Medtronic, Inc. to stop selling its SynchroMed II Infusion Pumps due to numerous manufacturing violations.
Infusion pumps are electronic medical devices that allow for the intravenous delivery of medications and other fluids at regular, timed intervals. While some infusion pumps are external, a number of these devices are intended to be implanted in the body, usually the abdomen. Implantable infusion pumps are connected to an implanted catheter, and must be periodically refilled with medications or fluids by a health care provider. Such devices may be used to treat a range of diseases and conditions, including diabetes, pain and muscle spasticity.
From 2005 until 2009, the FDA received approximately 56,000 reports of serious injury or death associated with external and implantable infusion pumps. Causes of infusion pump injuries may include:
In January 2017, the FDA disclosed that it had received numerous adverse event reports, some detailing serious injuries and deaths, associated with the use of implantable infusion pumps in the MRI setting. Many of the reports described medication dosing inaccuracies, as well as mechanical problems.
“Only implantable infusion pumps labeled as MR Conditional may be used safely within an MR environment, and only under the specified conditions of safe use,” the FDA said. “The specific conditions that health care practitioners and patients should follow before, during, and after the MRI exam vary by the make and model of the implantable infusion pump system. Importantly, each implantable pump model may have unique conditions that must be followed in order for a patient to safely undergo an MRI exam. Failure to adhere to these conditions can result in serious injury or death.”
In April 2015, Medtronic, Inc. entered into a consent decree with the FDA, and agreed to cease sales of its Medtronic SynchroMed II infusion pumps, except in cases where a doctor determined the device was medically necessary for a patient’s treatment. The agency had accused two of the company’s officers of repeatedly failing to address manufacturing violations.
SyncrhoMed Infusion Pumps were the subject of a Class I recall in February 2011, following reports that doctors were accidentally injecting drugs directly into patients’ subcutaneous tissues while attempting to refill the devices. The issue was linked to at least eight deaths and 270 serious injuries. Another Class I recall was announced in September 2011 due to reports of failing SyncrhoMed II batteries. The FDA also issued a warning letter to Medtronic in 2012, which directed the company to take effective corrective actions to deal with its infusion pump problems.
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