Premature Trigger of ERI in Medtronic EnRhythm Devices.
Pacing Clin Electrophysiol
; 40(6): 624-628, 2017 Jun.
Article
em En
| MEDLINE
| ID: mdl-28294359
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Marca-Passo Artificial
/
Fontes de Energia Elétrica
/
Análise de Falha de Equipamento
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Remoção de Dispositivo
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Falha de Equipamento
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Segurança de Equipamentos
/
Recall de Dispositivo Médico
Limite:
Aged
/
Female
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Humans
/
Male
País/Região como assunto:
Oceania
Idioma:
En
Revista:
Pacing Clin Electrophysiol
Ano de publicação:
2017
Tipo de documento:
Article
País de afiliação:
Austrália