The FDA is warning people using drug infusion pumps implanted in their bodies of the danger of and their pump failing while having a Magnetic Resonance Imaging (MRI), causing 1) potentially lethal medication dosing inaccuracies, such as over-infusion or under-infusion, or unintended bolus of medication and 2) other mechanical problems with the pump, such as motor stall or the pump not restarting after the MRI. Implantable infusion pumps are used to treat chronic pain, muscle spasticity, and many other diseases or conditions.
The FDA says that the MRI can cause the drug infusion devices to stop dosing accurately and the pumps to fail. Only infusion pumps identified as “MRI Conditional” can be safely used and people with infusion pumps should tell their doctor and MRI technician what kind of infusion pump they have.
People with infusion devices are given an implant card that identifies what type of pump they have and the FDA is advising them to have the card with them when they go for an MRI exam.
FDA: Implantable Infusion Pump May Malfunction During MRI
Six Figure Settlement
Wrongful Death
