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Serious injury or death can occur when patients with implanted neurological stimulators undergo MRI procedures
May 10, 2005 07:54

Date: Tue, 10 May 2005 15:01:23 -0400
From: CDER MEDWATCH LISTSERV
Subject: FDA MedWatch - MRI-Caused Injuries in Patients with Implanted Neu rological Stimulators

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA notified healthcare professionals that serious injury or death can occur when patients with implanted neurological stimulators undergo MRI procedures. The FDA received several reports of serious injury, including coma and permanent neurological impairment. The mechanism for these adverse events is likely to involve heating of the electrodes at the end of the leadwires, resulting in injury to the surrounding tissue. The public health notification also offered recommendations for preventive actions.