European Heart Rhythm Association Guidance Document on cardiac rhythm management product performance

被引：13

作者：

Auricchio, Angelo ^{[1
]}

Gropp, Michael ^{[1
]}

Ludgate, Susanne ^{[1
]}

Vardas, Panos ^{[1
]}

Brugada, Josep ^{[1
]}

Priori, Silvia G. ^{[1
]}

机构：

[1] Fdn Cardioctr Ticino, CH-6900 Lugano, Switzerland

来源：

EUROPACE | 2006年 / 8卷 / 05期

关键词：

pacemakers; implantable cardioverter defibrillators; field safety corrective actions; cardiac rhythm management;

D O I：

10.1093/europace/eul043

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

[No abstract available]

引用

页码：313 / 322

页数：10

共 17 条

[1] BECKER C, 2005, MOLD HEALTHC, V35, P20
[2] Variability in implantable cardioverter defibrillator pulse generator longevity between manufacturers
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Guy, ML
Ruskin, JN
McGovern, BA
[J]. PACE-PACING AND CLINICAL ELECTROPHYSIOLOGY, 2003, 26 (01): : 71 - 75
[3] FURMAN S, 1995, PACE, V18, P375, DOI 10.1111/j.1540-8159.1995.tb02532.x
[4] Goldman BS, 1996, CAN J CARDIOL, V12, P37
[5] Management of intracardiac device recalls: A consensus conference
Goldman, BS
Newman, D
Fraser, J
Irwin, M
[J]. PACE-PACING AND CLINICAL ELECTROPHYSIOLOGY, 1996, 19 (01): : 7 - 17
[6] Lessons from the failure and recall of an implantable cardioverter-defibrillator
Hauser, RG
Maron, BJ
[J]. CIRCULATION, 2005, 112 (13) : 2040 - 2042
[7] Deaths associated with implantable cardioverter defibrillator failure and deactivation reported in The United States Food and Drug Administration Manufacturer and User Facility Device Experience Database
Hauser, RG
Kallinen, L
[J]. HEART RHYTHM, 2004, 1 (04) : 399 - 405
[8] Medical device tracking: Results of a case study of the implantable cardioverter defibrillator
Kaczmarek, RG
Beaulieu, MD
Kessler, LG
[J]. AMERICAN JOURNAL OF CARDIOLOGY, 2000, 85 (05) : 588 - 592
[9] Failure rates of leads, pulse generators, and programmers have not diminished over the last 20 years: Formal monitoring of performance is still needed
Kawanishi, DT
Song, S
Furman, S
Parsonnet, V
Pioger, G
Petitot, JC
Godin, JF
[J]. PACE-PACING AND CLINICAL ELECTROPHYSIOLOGY, 1996, 19 (11): : 1819 - 1823
[10] THE IMPACT OF A MANUFACTURERS REVISION OF PACEMAKER SERVICE LIFE ON THE WORKLOAD OF A LARGE PACING CENTER
LLEWELLYN, MJ
BENNETT, DH
SHEARER, KS
SLAVEN, YM
[J]. PACE-PACING AND CLINICAL ELECTROPHYSIOLOGY, 1989, 12 (07): : 1014 - 1017

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