Implanted Medical Device May Cause Death, Injury from MRI

The FDA recently sent out a safety communication regarding serious adverse events experienced by patients with implantable infusion pumps in the magnetic resonance (MR) environment.

Multiple reports of patient injuries and deaths have been received due to medication dosing inaccuracy, and other mechanical problems with the pump after undergoing magnetic resonance imaging (MRI) exams, according to the FDA.

MRIs are a common imagining process that provides physicians with a clear image of the internal structures of the body, and can be used in diagnosing numerous conditions. However, it has been discovered that this imagining technique can be harmful for those with implantable infusion pumps.

The FDA warns that only devices that are labeled as “MR Conditional” are able to be used safely within that environment.

Other specifications that dictate the processes physicians and patients must follow before, during, and after the MRI exam vary among the different infusion pump systems. If these conditions are not followed precisely, patients may experience serious injury or death, according to the FDA.

The FDA discovered this issue during an analysis of adverse events and manufacturer labeling, and the agency is now working with manufacturers of the affected devices to ensure that instructions are clear and current.

Implantable infusion pumps are typically placed in the abdominal region, and deliver medication or fluids to the body via a catheter. These devices are indicated to treat conditions such as chronic pain, muscle spasticity, and others. The fluids are typically changed by a healthcare provider.

Patients with implantable infusion pumps should be aware of the specific instructions that must be followed during an MRI exam, since they differ by manufacturer and model, according to the FDA. Patients should also make it known that they have this device to prevent any potential harm.

The FDA suggests that patients bring their implant card to their exam, which contains information about the pump, and other instructions. The agency also suggests that patients obtain a medical alert bracelet or necklace to indicate they have an implantable infusion device, in case emergency treatment is required.

Patients must also be aware that the functionality of their device may be affected by an MRI exam, and could need to be reprogrammed, according to the FDA.

MRI technologists also play a role in the safety of these patients, and should screen for implantable infusion devices prior to starting an MRI exam. These healthcare professionals should also refrain from performing an MRI exam until they are certain the patient has an MR Conditional device to prevent adverse events.

The FDA recommends that radiologists consider the risks and benefits of these exams for patients, and include all devices in the initial risk assessment. Other healthcare providers, such as physicians who manage the implanted infusion pump, should be aware of the risks involved with a device that is not MR Conditional.

Patients and healthcare providers are encouraged by the FDA to report any adverse events to the MedWatch Safety Information and Adverse Event Reporting Program.