St. Jude Medical, a medical device company, is seeking a retraction of a manuscript accepted for publication in the Heart Rhythm Journal that suggests its cardiac devices are prone to more deaths than a comparable Medtronic device.
For the study, researchers relied on the FDA's Manufacturers and User Facility Device Experience database to determine possible deaths stemming from St. Jude's Riata and Riata ST devices compared to Medtronic's Quattro Secure leads. They found failures with the St. Jude and Medtronic devices caused 22 deaths and five deaths, respectively. Specifically, the researchers concluded St. Jude's devices demonstrated insulation defects.
St. Jude reportedly conducted an analysis with the same search criteria outlined in the above manuscript and has alleged the researchers "substantially undercounted total deaths in the MAUDE database for Quattro Secure, which therefore resulted in substantial errors related to how Riata and Riata ST leads compared to the Quattro Secure lead."
The company also alleged the research is flawed because it compares a recalled silicone-only insulated lead to a polyurethane-insulated product.
For the study, researchers relied on the FDA's Manufacturers and User Facility Device Experience database to determine possible deaths stemming from St. Jude's Riata and Riata ST devices compared to Medtronic's Quattro Secure leads. They found failures with the St. Jude and Medtronic devices caused 22 deaths and five deaths, respectively. Specifically, the researchers concluded St. Jude's devices demonstrated insulation defects.
St. Jude reportedly conducted an analysis with the same search criteria outlined in the above manuscript and has alleged the researchers "substantially undercounted total deaths in the MAUDE database for Quattro Secure, which therefore resulted in substantial errors related to how Riata and Riata ST leads compared to the Quattro Secure lead."
The company also alleged the research is flawed because it compares a recalled silicone-only insulated lead to a polyurethane-insulated product.
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