Please use this identifier to cite or link to this item: http://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: PACE - 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.
RMID: 0030066028
DOI: 10.1111/pace.13073
Appears in Collections:Medicine publications

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