{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T16:32:45Z","timestamp":1791822765713,"version":"4.3.4"},"reference-count":5,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2023,5,20]],"date-time":"2023-05-20T00:00:00Z","timestamp":1684540800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cardiovasc electrophysiol"],"published-print":{"date-parts":[[2023,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Leadless pacemaker (LP) offers an innovative approach for treating bradyarrhythmia, thus avoiding pacemaker pocket and lead\u2010related complications. The Food and Drug Administration (FDA) has recently approved the Aveir\u2122 leadless pacing system (screw\u2010in type LP).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We queried the FDA MAUDE database to study the safety profile and assess the types of complications with this relatively novel device technology. A MAUDE database search was conducted on January 20, 2023, for reports received post\u2010FDA approval to capture all adverse events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 98 medical device report were reported for Aveir\u2122 LP. After excluding duplicate, programmer\u2010related, or introducer\u2010sheath\u2010related entries (<jats:italic>n<\/jats:italic>\u2009=\u200934), 64 entries were included. The most commonly encountered problem was high threshold\/noncapture (28.1%, 18 events), followed by stretched helix (17.2%, 11 events) and device dislodgement (15.6%, ten events\u20145 intraprocedural, while 5 in the postoperative Day 1). Other reported events included high impedance (14.1%, nine events), sensing issues (12.5%, eight events), bent\/broken helix (7.8%, five events), premature separation (4.7%, three events), interrogation problem (3.1%, two events), low impedance (3.1%, two events), premature battery depletion (1.6%, one event) and inadvertent MRI mode switch (1.6%, one event) and miscellaneous (15.6%, <jats:italic>n<\/jats:italic>\u2009=\u200910). There were eight serious patient injury events\u2014pericardial effusion requiring pericardiocentesis (7.8%, five events) due to cardiac perforation that resulted in two deaths (3.1%) followed by sustained ventricular arrhythmias (4.6%, <jats:italic>n<\/jats:italic>\u2009=\u20093).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In our study assessing the real\u2010world safety profile of the Aveir\u2122 LP, serious adverse events have been reported\u2014life\u2010threatening ventricular arrhythmias, pericardial effusion, device explantation\/reimplantation, and death.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jce.15932","type":"journal-article","created":{"date-parts":[[2023,5,20]],"date-time":"2023-05-20T20:00:15Z","timestamp":1684612815000},"page":"1469-1471","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Adverse events associated with Aveir<sup>TM<\/sup> VR leadless pacemaker: A Food and Drug Administration MAUDE database study"],"prefix":"10.1111","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6857-7418","authenticated-orcid":false,"given":"Jalaj","family":"Garg","sequence":"first","affiliation":[{"name":"Cardiac Arrhythmia Service Loma Linda University Health Loma Linda California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1345-0719","authenticated-orcid":false,"given":"Kuldeep","family":"Shah","sequence":"additional","affiliation":[{"name":"Cardiac Arrhythmia Service, MercyOne Siouxland Heart and Vascular Center Sioux City Iowa USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rahul","family":"Bhardwaj","sequence":"additional","affiliation":[{"name":"Cardiac Arrhythmia Service Loma Linda University Health Loma Linda California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tahmeed","family":"Contractor","sequence":"additional","affiliation":[{"name":"Cardiac Arrhythmia Service Loma Linda University Health Loma Linda California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ravi","family":"Mandapati","sequence":"additional","affiliation":[{"name":"Cardiac Arrhythmia Service Loma Linda University Health Loma Linda California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohit K.","family":"Turagam","sequence":"additional","affiliation":[{"name":"Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1492-2693","authenticated-orcid":false,"given":"Dhanunjaya","family":"Lakkireddy","sequence":"additional","affiliation":[{"name":"Kansas City Heart Rhythm Institute and Research Foundation Kansas City Kansas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,5,20]]},"reference":[{"key":"e_1_2_2_2_1","first-page":"115","article-title":"Primary results on safety and efficacy from the LEADLESS II\u2010Phase 2 worldwide clinical trial","volume":"8","author":"Reddy VY","year":"2022","journal-title":"JACC"},{"key":"e_1_2_2_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2021.10.015"},{"key":"e_1_2_2_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/jce.15287"},{"key":"e_1_2_2_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2021.12.034"},{"key":"e_1_2_2_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2022.06.003"}],"container-title":["Journal of Cardiovascular Electrophysiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jce.15932","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,19]],"date-time":"2023-08-19T21:52:12Z","timestamp":1692481932000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jce.15932"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,5,20]]},"references-count":5,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2023,6]]}},"alternative-id":["10.1111\/jce.15932"],"URL":"https:\/\/doi.org\/10.1111\/jce.15932","archive":["Portico"],"relation":{},"ISSN":["1045-3873","1540-8167"],"issn-type":[{"value":"1045-3873","type":"print"},{"value":"1540-8167","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,5,20]]},"assertion":[{"value":"2023-02-26","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-04-29","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-05-20","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}