Maciej Grymuza, Lidia Chmielewska-Michalak, Agnieszka Katarzyńska-Szymańska, Jacek Migaj, Maciej Lesiak, Przemysław Mitkowski
{"title":"召回设备:在初始访问和远程监控期间的缺陷支持后续。","authors":"Maciej Grymuza, Lidia Chmielewska-Michalak, Agnieszka Katarzyńska-Szymańska, Jacek Migaj, Maciej Lesiak, Przemysław Mitkowski","doi":"10.1111/pace.14552","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>In March 2021, Biotronik informed about the risk of premature battery depletion in a group of implantable cardioverter-defibrillators. Following the manufacturers' recommendation, our center executed a recall and introduced remote monitoring (RM) in patients with susceptible devices. This study reports the rate of premature battery depletion in our center and events found in RM-supported follow-up.</p><p><strong>Methods: </strong>Single-center observational study.</p><p><strong>Results: </strong>Out of the 206 susceptible implanted devices, 125 patients appeared for the visit and RM was introduced in 107 (83%) patients. Until the visit, three (2.4%) devices required replacement due to battery depletion, and a further three (2.4%) devices had unexpected battery depletion during follow-up.</p><p><strong>Conclusions: </strong>The recalled devices had a higher rate of battery exhaustion than expected, while other device or lead defects were less common.</p>","PeriodicalId":520740,"journal":{"name":"Pacing and clinical electrophysiology : PACE","volume":" ","pages":"1320-1322"},"PeriodicalIF":1.3000,"publicationDate":"2022-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Recall devices: Defects at initial visit and during remote monitoring supported follow-up.\",\"authors\":\"Maciej Grymuza, Lidia Chmielewska-Michalak, Agnieszka Katarzyńska-Szymańska, Jacek Migaj, Maciej Lesiak, Przemysław Mitkowski\",\"doi\":\"10.1111/pace.14552\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>In March 2021, Biotronik informed about the risk of premature battery depletion in a group of implantable cardioverter-defibrillators. Following the manufacturers' recommendation, our center executed a recall and introduced remote monitoring (RM) in patients with susceptible devices. This study reports the rate of premature battery depletion in our center and events found in RM-supported follow-up.</p><p><strong>Methods: </strong>Single-center observational study.</p><p><strong>Results: </strong>Out of the 206 susceptible implanted devices, 125 patients appeared for the visit and RM was introduced in 107 (83%) patients. Until the visit, three (2.4%) devices required replacement due to battery depletion, and a further three (2.4%) devices had unexpected battery depletion during follow-up.</p><p><strong>Conclusions: </strong>The recalled devices had a higher rate of battery exhaustion than expected, while other device or lead defects were less common.</p>\",\"PeriodicalId\":520740,\"journal\":{\"name\":\"Pacing and clinical electrophysiology : PACE\",\"volume\":\" \",\"pages\":\"1320-1322\"},\"PeriodicalIF\":1.3000,\"publicationDate\":\"2022-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pacing and clinical electrophysiology : PACE\",\"FirstCategoryId\":\"5\",\"ListUrlMain\":\"https://doi.org/10.1111/pace.14552\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/7/9 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pacing and clinical electrophysiology : PACE","FirstCategoryId":"5","ListUrlMain":"https://doi.org/10.1111/pace.14552","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/7/9 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
Recall devices: Defects at initial visit and during remote monitoring supported follow-up.
Background: In March 2021, Biotronik informed about the risk of premature battery depletion in a group of implantable cardioverter-defibrillators. Following the manufacturers' recommendation, our center executed a recall and introduced remote monitoring (RM) in patients with susceptible devices. This study reports the rate of premature battery depletion in our center and events found in RM-supported follow-up.
Methods: Single-center observational study.
Results: Out of the 206 susceptible implanted devices, 125 patients appeared for the visit and RM was introduced in 107 (83%) patients. Until the visit, three (2.4%) devices required replacement due to battery depletion, and a further three (2.4%) devices had unexpected battery depletion during follow-up.
Conclusions: The recalled devices had a higher rate of battery exhaustion than expected, while other device or lead defects were less common.