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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
Statement of
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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