{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T04:01:53Z","timestamp":1791345713124,"version":"4.3.1"},"reference-count":9,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2011,11,18]],"date-time":"2011-11-18T00:00:00Z","timestamp":1321574400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2012,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The Food and Drug Administration (FDA) became aware of lead fracture and inappropriate shock events related to Sprint Fidelis leads in January 2007. The manufacturer announced a voluntary market withdrawal in October 2007.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>Our aim was to retrospectively evaluate this safety signal using disproportionality analysis to estimate whether disproportionality analysis could have detected this particular safety signal earlier than actually occurred.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>The Manufacturer and User Facility Device Experience (MAUDE) database contains reports on device\u2010related adverse events, of which, FDA receives several hundred thousand every year. For each manufacturer, a list of the top lead brand names was ranked by frequency of reports. We used the Multi\u2010item Gamma Poisson Shrinker (MGPS) method for analysis. We isolated 11 top\u2010reported implantable cardioverter defibrillator (ICD) lead brand names. Using MGPS methodology, we calculated the one\u2010sided 95% lower confidence bound EB05 on the empirical Bayes geometric mean of the reporting ratio.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We performed individual MGPS analysis for each of the top reported adverse events in 2006 for ICD leads. Fidelis had the highest EB05 scores for lead fractures and inappropriate shock.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>Through disproportionality analysis of the MAUDE database, we were able to identify known safety signals associated with the Medtronic Sprint Fidelis lead.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>If utilized at the time, this disproportionality analysis would have identified signals earlier for lead fractures, oversensing, high impedance, and inappropriate shock. Copyright \u00a9 2011 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.2261","type":"journal-article","created":{"date-parts":[[2011,11,18]],"date-time":"2011-11-18T07:41:03Z","timestamp":1321602063000},"page":"87-93","source":"Crossref","is-referenced-by-count":14,"title":["Disproportionality analysis for signal detection of implantable cardioverter\u2013defibrillator\u2010related adverse events in the Food and Drug Administration Medical Device Reporting System"],"prefix":"10.1002","volume":"21","author":[{"given":"Hesha J.","family":"Duggirala","sequence":"first","affiliation":[{"name":"Division of Epidemiology, Center for Devices and Radiological Health Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naomi D.","family":"Herz","sequence":"additional","affiliation":[{"name":"Division of Epidemiology, Center for Devices and Radiological Health Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel Arthur","family":"Ca\u00f1os","sequence":"additional","affiliation":[{"name":"Division of Epidemiology, Center for Devices and Radiological Health Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberta A.","family":"Sullivan","sequence":"additional","affiliation":[{"name":"Division of Postmarket Surveillance, Center for Devices and Radiological Health Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Schaaf","sequence":"additional","affiliation":[{"name":"Oracle Health Sciences Global Business Unit Oracle Corporation  Waltham MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellen","family":"Pinnow","sequence":"additional","affiliation":[{"name":"Division of Epidemiology, Center for Devices and Radiological Health Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danica","family":"Marinac\u2010Dabic","sequence":"additional","affiliation":[{"name":"Division of Epidemiology, Center for Devices and Radiological Health Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2011,11,18]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.2307\/2686093"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2007.03.041"},{"key":"e_1_2_8_4_1","unstructured":"Urgent Medical Device Information Sprint Fidelis\u00ae Lead Patient Management Recommendations.http:\/\/www.medtronic.com\/product\u2010advisories\/physician\/sprint\u2010fidelis\/PROD\u2010ADV\u2010PHYS\u2010OCT.htm[22 September2010]."},{"key":"e_1_2_8_5_1","unstructured":"Manufacturer and User Facility Device Experience Database \u2010 (MAUDE).http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/PostmarketRequirements\/ReportingAdverseEvents\/ucm127891.htm[13 August2010]."},{"key":"e_1_2_8_6_1","unstructured":"DuMouchelW.Bayesian measurement of associations in adverse drug reaction databases.Proceedings of the Joint Statistical Meetings New York City 13 August2002 presentation slides athttp:\/\/nymetro.chapter.informs.org\/prac_cor_pubs\/dumouchel_nov\u201013\u201002.pdf"},{"key":"e_1_2_8_7_1","doi-asserted-by":"crossref","unstructured":"DuMouchelW PregibonD.Empirical Bayes Screening for Multi\u2010Item Associations.Proceedings of the ACMSIGKDD 2001 International Conference on Knowledge Discovery from Data 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