Multicenter experience with failed and recalled implantable cardioverter-defibrillator pulse generators

Heart Rhythm

Volumn 3, Issue 6, 2006, Pages 640-644

  Hauser, Robert G ^a   Hayes, David L ^b   Epstein, Andrew E ^c   Cannom, David S ^d   Vlay, Stephen C ^e   Song, Susan L ^f   Tyers, G Frank O ^g  

^a MINNEAPOLIS HEART INSTITUTE FOUNDATION   (United States)

^b MAYO CLINIC   (United States)

^c UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^d GOOD SAMARITAN HOSPITAL   (United States)

^e STONY BROOK UNIVERSITY MEDICAL CENTER   (United States)

^f UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^g UNIVERSITY OF BRITISH COLUMBIA   (Canada)

Author keywords

Complications; Implantable cardioverter defibrillator; Pulse generator; Registry

Indexed keywords

ARTICLE; CARDIAC RESYNCHRONIZATION THERAPY; CLINICAL STUDY; CONTROLLED STUDY; DEFIBRILLATION; DEFIBRILLATOR; DEVICE REMOVAL; ELECTRONICS; EQUIPMENT DESIGN; FUNCTIONAL ASSESSMENT; HEART PACING; HEART VENTRICLE TACHYCARDIA; HUMAN; INCIDENCE; INFECTION; LONGEVITY; MORTALITY; PACEMAKER FAILURE; PRIORITY JOURNAL; PROSPECTIVE STUDY; PULSE GENERATOR; STATISTICAL ANALYSIS; STROKE; SYNCOPE; WOUND COMPLICATION;

EID: 33646775709     PISSN: 15475271     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.hrthm.2006.02.011     Document Type: Article

References (20)

1. The Antiarrhythmic versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med 337 (1997) 1576-1583
2. Moss A.J., Zareba W., Hall W.J., Klein H., Wilber D.J., Cannom D.S., Daubert J.P., Higgins S.L., Brown M.W., Andrews M.L., and Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 346 (2002) 877-883
3. Buxton A.E., Lee K.L., Fisher J.D., Josephson M.E., Prystowsky E.N., and Hafley G. A randomized study of the prevention of sudden death in patients with coronary artery disease. N Engl J Med 342 (2000) 1937-1945
4. Kadish A., Dyer A., Daubert J.P., Quigg R., Estes N.A., Anderson K.P., Calkins H., Hoch D., Goldberger J., Shalaby A., Sanders W.E., Schaechter A., Levine J.H., and Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med 350 (2004) 2151-2158
5. Bardy G.H., Lee K.L., Mark D.B., Poole J.E., Packer D.L., Boineau R., Domanski M., Troutman C., Anderson J., Johnson G., McNulty S.E., Clapp-Channing N., Davidson-Ray L.D., Fraulo E.S., Fishbein D.P., Luceri R.M., Ip J.H., and Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 352 (2005) 225-237
6. McClellan M.B., and Tunis S.R. Medicare coverage of ICDs. N Engl J Med 352 (2005) 222-224
7. Maisel WH. Pacemaker and ICD malfunctions. Information from the September 16, 2005 Policy Conference on Pacemaker and ICD Performance Presented by the Heart Rhythm Society in Cooperation with the U.S. Food and Drug Administration 2005. Available at: http://www.fda.gov/cdrh/ocd/icd/. Accessed April 12, 2006.
8. Hauser R.G., Hayes D., Parsonnet V., Furman S., Epstein A., Hayes J., Saksena S., Irwin M., Almquist A., Cannom D., Gross J., and Kallinen L. Feasibility and initial results of an Internet-based pacemaker and ICD pulse generator and lead registry. Pacing Clin Electrophysiol 24 (2001) 82-87
9. Hauser R., Hayes D., Cannom D., Parsonnet V., Furman S., Epstein A., Vlay S., Tyers G., Irwin M., Almquist A., Song S., Hayes J., and Kallinen L. Performance of pacemaker and implantable cardioverter defibrillator pulse generators and leads. results from the Multicenter Registry. In: Tse H.-F., Lee K.L.F., and Lau C.-K. (Eds). Clinical pacing and electrophysiology (2003), Monduzzi Editore, Bologna, Italy 173-179
10. Hauser R.G., Hayes D., Almquist A.K., Epstein A.E., Parsonnet V., Tyers G.F., Vlay S.C., and Schoenfeld M.H. Unexpected ICD pulse generator failure due to electronic circuit damage caused by electrical overstress. Pacing Clin Electrophysiol 24 (2001) 1046-1054
11. Wild D.M., Fisher J.D., Kim S.G., Ferrick K.J., Gross J.N., and Palma E.C. Pacemakers and implantable cardioverter defibrillators: device longevity is more important than smaller size: the patient's viewpoint. Pacing Clin Electrophysiol 27 (2004) 1526-1529
12. Maisel W.H. Safety issues involving medical devices. implications of recent implantable cardioverter-defibrillator malfunctions. JAMA 294 (2005) 955-958
13. Myrum S. Marquis ICD and CRT-D devices. Medtronic letter to physicians (2005) February
14. Steinbrook R. The controversy over Guidant's implantable defibrillators. N Engl J Med 353 (2005) 221-224
15. Gornick C.C., Hauser R.G., Almquist A.K., and Maron B.J. Unpredictable implantable cardioverter-defibrillator pulse generator failure due to electrical overstress causing sudden death in a young high-risk patient with hypertrophic cardiomyopathy. Heart Rhythm 2 (2004) 681-683
16. Hauser R.G., and Kallinen L. 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. Heart Rhythm 1 (2004) 399-405
17. Jauhar S., and Slotwiner D.J. The economics of ICDs. N Engl J Med 351 (2004) 2542-2544
18. Hauser R.G. The growing mismatch between patient longevity and the service life of implantable cardioverter defibrillators. J Am Coll Cardiol 45 (2005) 2022-2025
19. Sanders G.D., Hlatky M.A., and Owens D.K. Cost-effectiveness of implantable cardioverter-defibrillators. N Engl J Med 353 (2005) 1471-1480
20. Song S. Performance of implantable cardiac rhythm management devices. Pacing Clin Electrophysiol 17 (1994) 692-708