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 (27)  • Contact me when this article is cited  Related Content  • Related letters  • Related article  • Similar articles in JAMA  Topic Collections  • Pacemakers/ Defibrillators  • Cardiovascular System  • Quality of Care  • Quality of Care, Other  • Cardiovascular Intervention  • Alert me on articles by topic  Social Bookmarking   What's this?

Implications of Recent Implantable Cardioverter-Defibrillator Malfunctions

William H. Maisel, MD, MPH

JAMA. 2005;294:955-958.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

This past spring, Joshua Oukrop, a 21-year old Minnesota college student with familial hypertrophic cardiomyopathy, died of cardiac arrest when his implantable cardioverter-defibrillator (ICD) short-circuited and failed to resuscitate him.¹ Guidant Corporation (Indianapolis, Ind), the maker of his ICD, was aware of the potential for this type of malfunction, having observed 26 similar failures out of 37 000 devices.^1-2 The company, however, decided not to notify physicians of the flaw for more than 3 years after first detecting it.^1-2 As implantations of complex electrophysiological devices become increasingly commonplace, the number of patients affected by defective devices can be expected to increase. Understanding the history of medical device regulation, the benefits and limitations of technology, the obligations of manufacturers, the expectations of physicians and patients, and the responsibilities of national physician and industry organizations can provide a framework for improving the medical device reporting and notification systems.

History of Medical Device Regulation

. . . [Full Text of this Article]

Author Affiliation: Cardiovascular Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass.

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

RELATED LETTERS

Malfunctions of Implantable Cardioverter Defibrillators
Paul A. Levine and Gabriel Kohanyi
JAMA. 2006;295(2):161.
EXTRACT | FULL TEXT  

Malfunctions of Implantable Cardioverter Defibrillators—Reply
William H. Maisel
JAMA. 2006;295(2):161-162.
EXTRACT | FULL TEXT  

RELATED ARTICLE

Primary Prophylaxis With the Implantable Cardioverter-Defibrillator: The Need for Improved Risk Stratification
Anil Gehi, Donald Haas, and Valentin Fuster
JAMA. 2005;294(8):958-960.
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  

Devices, biology, imaging, and the regulatory processes...
Chandrashekhar et al.
J Am Coll Cardiol Img 2009;2:670-673.
FULL TEXT  

Implantable Cardioverter-Defibrillators after Myocardial Infarction
Myerburg
NEJM 2008;359:2245-2253.
FULL TEXT  

Semper Fidelis -- Consumer Protection for Patients with Implanted Medical Devices
Maisel
NEJM 2008;358:985-987.
FULL TEXT  

Device therapy in heart failure
McAlister
BMJ 2007;335:895-896.
FULL TEXT  

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

The high cost of implantable defibrillators
Hlatky and Mark
Eur Heart J 2007;28:388-391.
ABSTRACT | FULL TEXT  

Short QT syndrome and arrhythmogenic cardiac diseases in the young: the challenge of implantable cardioverter-defibrillator therapy for children
Boriani et al.
Eur Heart J 2006;27:2382-2384.
FULL TEXT  

Recalls and safety alerts affecting automated external defibrillators.
Shah and Maisel
JAMA 2006;296:655-660.
ABSTRACT | FULL TEXT  

Automated external defibrillators--device reliability and clinical benefits.
Estes
JAMA 2006;296:700-702.
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  

Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration annual reports.
Maisel et al.
JAMA 2006;295:1901-1906.
ABSTRACT | FULL TEXT  

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

JAMA's policy on industry sponsored studies
Fontanarosa and DeAngelis
BMJ 2006;332:177-177.
FULL TEXT  

Malfunctions of Implantable Cardioverter Defibrillators
Levine and Kohanyi
JAMA 2006;295:161-161.
FULL TEXT  

Conflicts of Interest and Independent Data Analysis in Industry-Funded Studies--Reply
Fontanarosa and DeAngelis
JAMA 2005;294:2576-2577.
FULL TEXT