Medtronic Insulin Pumps and MRIs
Recently, Medtronic became aware of cases where exposure to strong magnetic fields like Magnetic Resonance Imaging (MRI) resulted in damage to Medtronic Paradigm insulin infusion pumps. Medtronic has taken this situation very seriously, and we have voluntarily notified our patients, physicians and the FDA about these incidences, reinforcing the need for caution when using our insulin infusion pumps while in close proximity to strong magnetic fields like MRIs.
The FDA has agreed with our assessment of the situation, and categorized this announcement as a Class II Field Correction, requiring us only to notify patients of the potential risk MRIs pose to their insulin pumps. Patients should not be concerned or take any further action unless they believe their Paradigm insulin pump has been exposed to an MRI machine. Patients should not return their Paradigm insulin pump to Medtronic unless they believe this exposure has taken place.
Extensive testing with other magnetized devices such as airport metal detectors, electronic article surveillance equipment and cellular phones will not adversely affect pump operation.
Last Updated: Friday July 20, 2007 08:42:30
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