Pacemaker and ICD generator malfunctions: Analysis of Food and Drug Administration annual reports
Article Abstract:
The postapproval annual reports submitted to the US Food and Drug Administration (FDA) by manufacturers of pacemakers and implantable cardioverter-defibrillators (ICDs) is analyzed to determine the reported number and rate of pacemaker and ICD malfunctions. Although pacemakers and ICDs are important life-sustaining devices that have saved many lives, careful monitoring of device performance is still required.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 2006
User Contributions:
Comment about this article or add new information about this topic:
Pacemaker and ICD malfunction: An incomplete picture
Article Abstract:
Pacemakers and (ICDs) are dependent on the entire implanted system to function properly where the device, the leads, the chosen programmed parameters, and the patient's response are all interdependent. The system malfunction rate may be the most important measure of reliability, but it is also the most elusive because no single measure captures all elements in a verifiable fashion.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 2006
User Contributions:
Comment about this article or add new information about this topic:
- Abstracts: Pacemaker and ICD generator reliability: Meta-analysis of device registries. Implantable defibrillators for the prevention of morality in patients with nonischemic cardiomyopathy: A meta-analysis of randomized controlled trials
- Abstracts: Will care checks raise standards? An overview of the new resuscitation guidelines. New guideline on preventing and managing pressure ulcers
- Abstracts: Politics and independence - The collapse of the Canadian Medical Association Journal. Improving global health - Margaret Chan at the WHO
- Abstracts: Fluid intake and bladder and bowel function. Ministering to spiritual needs. Caring for the children in care
- Abstracts: End-of-life decisions and respiratory disease. How to guard against assault