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St. Jude Medical (STJ) Releases MAUDE Database; Says Six-Fold Overstatment in Number of Deaths

April 10, 2012 10:31 AM EDT
St. Jude Medical, Inc. (NYSE: STJ), has posted information from the MAUDE database showing 377 deaths associated with the Medtronic (Nasdaq: MDT) Quattro Secure lead, rather than the 62 that was reported by Dr. Robert Hauser in a manuscript published online last week by the Heart Rhythm Journal.

Dr. Hauser’s review of the number of deaths in the MAUDE database was wrong by greater than a factor of six.

The company has called upon Dr. Hauser to state specifically whether or not he stands behind the factual accuracy of the number 62 used in comparing the St. Jude Medical Riata® and Riata ST leads to the Medtronic Quattro Secure device. The company also invites Medtronic to review the MAUDE database report findings.


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