This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (49)  • Contact me when this article is cited  Related Content  • Related letter  • Related articles  • Similar articles in JAMA  Topic Collections  • Pacemakers/ Defibrillators  • Cardiovascular System  • Quality of Care  • Quality of Care, Other  • Arrhythmias  • Cardiovascular Intervention  • Alert me on articles by topic  Social Bookmarking   What's this?

Analysis of Food and Drug Administration Annual Reports

William H. Maisel, MD, MPH; Megan Moynahan, MS; Bram D. Zuckerman, MD; Thomas P. Gross, MD, MPH; Oscar H. Tovar, MD; Donna-Bea Tillman, PhD, MPA; Daniel B. Schultz, MD

JAMA. 2006;295:1901-1906.

Context  Pacemakers and implantable cardioverter-defibrillators (ICDs) are complex medical devices proven to reduce mortality in specific high-risk patient populations. It is not known if increasing device complexity is associated with decreased reliability.

Objectives  To analyze postapproval annual reports submitted to the US Food and Drug Administration (FDA) by manufacturers of pacemakers and ICDs to determine the reported number and rate of pacemaker and ICD malfunctions and to assess trends in device performance.

Design and Setting  Pacemaker and ICD annual reports submitted to the FDA for the years 1990-2002 were reviewed. A pacemaker or ICD generator was defined as having malfunctioned if it was explanted due to an observed malfunction, returned to the manufacturer, and confirmed by the manufacturer to be functioning inappropriately. Leads and biventricular devices were not included in the study. Deaths were attributed to device malfunction only if they were witnessed, the malfunction immediately led to the death, and the malfunction was confirmed by the manufacturer.

Main Outcome Measures  Number of implanted pacemaker and ICD generators; number of reported malfunctions; and annual malfunction replacement rates. Generator malfunction replacement rates were defined as the annual number of replacements due to confirmed malfunction divided by the annual number of implants.

Results  During the study period, 2.25 million pacemakers and 415 780 ICDs were implanted in the United States. Overall, 17 323 devices (8834 pacemakers and 8489 ICDs) were explanted due to confirmed malfunction. Battery/capacitor abnormalities (4085 malfunctions [23.6%]) and electrical issues (4708 malfunctions [27.1%]) accounted for half of the total device failures. The annual pacemaker malfunction replacement rate per 1000 implants decreased significantly during the study, from a peak of 9.0 in 1993 to a low of 1.4 in 2002 (P = .006 for trend). In contrast, the ICD malfunction replacement rate per 1000 implants, after decreasing from 38.6 in 1993 to 7.9 in 1996, increased markedly during the latter half of the study, peaking in 2001 at 36.4 (P = .04 for trend). More than half of the reported ICD malfunctions occurred in the last 3 years of the study. Overall, the annual ICD malfunction replacement rate was significantly higher than the pacemaker malfunction replacement rate (mean [SD], 20.7 [11.6] vs 4.6 [2.2] replacements per 1000 implants; P<.001; rate ratio, 5.9 [95% confidence interval, 2.7-9.1]). Sixty-one deaths (30 pacemaker patients, 31 ICD patients) were attributable to device malfunction.

Conclusions  This study demonstrates that thousands of patients have been affected by pacemaker and ICD malfunctions, the pacemaker malfunction replacement rate has decreased, the ICD malfunction replacement rate increased during the latter half of the study, and the ICD malfunction replacement rate is significantly higher than that for pacemakers. Although pacemakers and ICDs are important life-sustaining devices that have saved many lives, careful monitoring of device performance is still required.

Author Affiliations: Cardiovascular Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass (Dr Maisel) and US Food and Drug Administration, Center for Devices and Radiologic Health, Rockville, Md (Ms Moynahan and Drs Zuckerman, Gross, Tovar, Tillman, and Schultz).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

RELATED LETTER

Outcomes of Medicare Beneficiaries With Ventricular Assist Devices—Reply
Adrian F. Hernandez, Bradley G. Hammill, and Lesley H. Curtis
JAMA. 2009;301(16):1658.
EXTRACT | FULL TEXT  

RELATED ARTICLES

Complications Associated With Implantable Cardioverter-Defibrillator Replacement in Response to Device Advisories
Paul A. Gould, Andrew D. Krahn, and for the Canadian Heart Rhythm Society Working Group on Device Advisories
JAMA. 2006;295(16):1907-1911.
ABSTRACT | FULL TEXT  

Pacemaker and ICD Generator Reliability: Meta-analysis of Device Registries
William H. Maisel
JAMA. 2006;295(16):1929-1934.
ABSTRACT | FULL TEXT  

Pacemaker and ICD Malfunction—An Incomplete Picture
Bruce L. Wilkoff
JAMA. 2006;295(16):1944-1946.
EXTRACT | FULL TEXT  

Implantable Cardioverter-Defibrillators
Janet M. Torpy, Alison E. Burke, and Richard M. Glass
JAMA. 2006;295(16):1964.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Predicting future shocks in implantable cardioverter defibrillator recipients: the role of biomarkers
Kanoupakis et al.
Europace 2009;11:1434-1439.
ABSTRACT | FULL TEXT  

Predicting Ventricular Arrhythmias in Patients With Ischemic Heart Disease: Clinical Application of the ECG-Derived QRS-T Angle
Borleffs et al.
Circ Arrhythm Electrophysiol 2009;2:548-554.
ABSTRACT | FULL TEXT  

Pacemaker dependency after implantation of electrophysiological devices
Korantzopoulos et al.
Europace 2009;11:1151-1155.
ABSTRACT | FULL TEXT  

Severely malfunctioning defibrillator with cardiac resynchronization therapy showing no abnormalities during testing with the programming head in place
Bjerregaard and Brown
Europace 2009;11:1112-1114.
FULL TEXT  

Outcomes of Medicare Beneficiaries With Ventricular Assist Devices--Reply
Hernandez et al.
JAMA 2009;301:1658-1658.
FULL TEXT  

Impact of the main implantable cardioverter-defibrillator trials in clinical practice: data from the Italian ICD Registry for the years 2005-07
Proclemer et al.
Europace 2009;11:465-475.
ABSTRACT | FULL TEXT  

National registry data on implantable cardioverter defibrillator treatment: what are they useful for?
Nielsen
Europace 2009;11:405-406.
FULL TEXT  

Remote implantable cardioverter defibrillator monitoring in a Brugada syndrome population
Sacher et al.
Europace 2009;11:489-494.
ABSTRACT | FULL TEXT  

Choosing pacemakers appropriately
Panicker et al.
Heart Asia 2009;2009:11-15.
ABSTRACT | FULL TEXT  

Inappropriate ICD Shocks Caused by External Electrical Noise
Thogersen et al.
NEJM 2009;360:1363-1364.
FULL TEXT  

How to Respond to an Implantable Cardioverter-Defibrillator Recall
Kirian et al.
Circulation 2009;119:e189-e191.
FULL TEXT  

Heart Disease and Stroke Statistics--2009 Update: A Report From the American Heart Association Statistics Committee and Stroke Statistics Subcommittee
WRITING GROUP MEMBERS et al.
Circulation 2009;119:e21-e181.
FULL TEXT  

Performance and survival of transvenous defibrillation leads: need for a European data registry
Goette et al.
Europace 2009;11:31-34.
ABSTRACT | FULL TEXT  

Diffusion Of New Technology And Payment Policies: Coronary Stents
Shih and Berliner
Health Aff (Millwood) 2008;27:1566-1576.
ABSTRACT | FULL TEXT  

A Critical Appraisal of Implantable Cardioverter-Defibrillator Therapy for the Prevention of Sudden Cardiac Death
Tung et al.
J Am Coll Cardiol 2008;52:1111-1121.
ABSTRACT | FULL TEXT  

ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) Developed in Collaboration With the American Association for Thoracic Surgery and Society of Thoracic Surgeons
Epstein et al.
J Am Coll Cardiol 2008;51:e1-e62.
FULL TEXT  

ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): Developed in Collaboration With the American Association for Thoracic Surgery and Society of Thoracic Surgeons
Writing Committee Members et al.
Circulation 2008;117:e350-e408.
FULL TEXT  

Early automatic remote detection of combined lead insulation defect and ICD damage
Neuzil et al.
Europace 2008;10:556-557.
ABSTRACT | FULL TEXT  

The Year in Epidemiology, Health Services Research, and Outcomes Research
Krumholz and Masoudi
J Am Coll Cardiol 2007;50:2254-2262.
FULL TEXT  

The follow-up of cardiac devices: what to expect for the future?
Stellbrink and Trappe
Eur Heart J Suppl 2007;9:I113-I115.
ABSTRACT | FULL TEXT  

Transvenous Implantable Cardioverter-Defibrillator Leads: The Weakest Link
Maisel
Circulation 2007;115:2461-2463.
FULL TEXT  

A 59-Year-Old Man Considering Implantation of a Cardiac Defibrillator
Zimetbaum
JAMA 2007;297:1909-1916.
ABSTRACT | FULL TEXT  

Update in Critical Care 2006
Milbrandt et al.
Am. J. Respir. Crit. Care Med. 2007;175:638-648.
FULL TEXT  

Contemporary Pacemaker and Defibrillator Device Therapy: Challenges Confronting the General Cardiologist
Schoenfeld
Circulation 2007;115:638-653.
FULL TEXT  

The long-term cost-effectiveness of cardiac resynchronization therapy with or without an implantable cardioverter-defibrillator
Yao et al.
Eur Heart J 2007;28:42-51.
ABSTRACT | FULL TEXT  

ICD and Pacemaker Malfunctions
Journal Watch Cardiology 2006;2006:9-9.
FULL TEXT  

Management of recalled pacemakers and implantable cardioverter-defibrillators: a decision analysis model.
Amin et al.
JAMA 2006;296:412-420.
ABSTRACT | FULL TEXT  

Clinical Trials for Cardiac Pacing in Bradycardia: The End or the Beginning?
Tse and Lau
Circulation 2006;114:3-5.
FULL TEXT  

JournalScan
Malik
Heart 2006;92:1007-1008.
FULL TEXT  

Increasing Rate of ICD Malfunctions
JWatch Emergency Med. 2006;2006:11-11.
FULL TEXT  

ICD and Pacemaker Malfunctions
Journal Watch Cardiology 2006;2006:2-2.
FULL TEXT  

Pacemaker and ICD generator reliability: meta-analysis of device registries.
Maisel
JAMA 2006;295:1929-1934.
ABSTRACT | FULL TEXT  

Pacemaker and ICD malfunction--an incomplete picture.
Wilkoff
JAMA 2006;295:1944-1946.
FULL TEXT