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https://hdl.handle.net/2440/106879
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Type: | Journal article |
Title: | Premature Trigger of ERI in Medtronic EnRhythm Devices |
Author: | Middeldorp, M. Mahajan, R. Elliott, A. Pathak, R. Twomey, D. Wilson, L. Stolcman, S. Munawar, D. Kumar, S. Lau, D. Sanders, P. |
Citation: | Pacing and Clinical Electrophysiology, 2017; 40(6):624-628 |
Publisher: | Wiley |
Issue Date: | 2017 |
ISSN: | 0147-8389 1540-8159 |
Statement of Responsibility: | Melissa E. Middeldorp, Rajiv Mahajan, Adrian D. Elliott, Rajeev K. Pathak, Darragh Twomey, Lauren Wilson, Simon Stolcman, Dian A. Munawar, Sharath Kumar, Dennis H. Lau and Prashanthan Sanders |
Abstract: | Background: Medical technology has made significant advances over the last few decades with smaller and more dynamic pacemakers. However, technical failures leading to premature replacement is a cause of concern. We present a series of Medtronic EnRhythm devices that reached premature elective replacement indicator (ERI). Methods: The database of Centre of Heart Rhythm Disorders was searched for EnRhythm device implantation from 2006 to 2011. Battery depletion <8.5 years was considered premature considering the projected average longevity to be 8.5–10.5 years. An unexpected premature ERI was defined when it was reached within 3 months of last normal check. Device follow-up was conducted every 3 months after advisory. Results: A total of 88 EnRhythm pacemakers were implanted. Over a median follow-up of 6.2 years (range: 0.3–9.2), 39 (44.3%) EnRhythm devices reached premature ERI. In 11 (28%), ERI was not recognized and patients were being investigated for other causes of unsteadiness or dyspnea prior to device check. Notably, three (7%) patients had premature ERI < 3.5 years. Ten (25.6%) had sudden and unexpected premature ERI. While asynchronous pacing was observed, there were no cases of absence of pacing. Conclusions: The rate of premature ERI for EnRhythm devices was 44.3%, significantly higher than reported by the manufacturer. Of concern, a sizeable proportion occurred unexpectedly, warranting more frequent reviews and empirical replacement in some patients. With the experience of the EnRhythm, appropriate monitoring strategies are recommended for future advisories. |
Keywords: | device recalls elective replacement indicator pacemaker remote monitoring |
Rights: | © 2017 Wiley Periodicals, Inc. |
DOI: | 10.1111/pace.13073 |
Published version: | http://dx.doi.org/10.1111/pace.13073 |
Appears in Collections: | Aurora harvest 3 Medicine publications |
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