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U.S. Department of Health and Human Services

MDR Database Search

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BRAND NAMESIGMA MR SYSTEM
MANUFACTURER
GENERAL ELECTRIC MEDICAL SYSTEMS
PO BOX 414, W709
MILWAUKEE WI 53201
ACCESS NUMBERM175218
PRODUCT CODELNH
PANELRADIOLOGICAL
REPORT TYPEDEATH
DATE FDA RECEIVED09/19/1989
DEVICE MODEL NUMBER46-271752G1
EVENT DESCRIPTION TYPEFINAL
EVENT DESCRIPTION
IT WAS REPORTED TO CO THAT A PT WITH A PACEMAKER DIED DURING, OR AFTER, AN MR EXAM, AND THAT THE CORONER DETERMINED THE DEATH WAS DUE TO THE INTERRUPTION OF THE PACEMAKER BY THE MR SYSTEM.
CLOSEOUT TEXT
THE CAUSE OF THIS EVENT HAS BEEN DETERMINED TO BE THE USE OF THE DEVICE.
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