Recalls and Safety Alerts Involving Pacemakers and Implantable Cardioverter-Defibrillator Generators
Article Abstract:
The FDA issued 52 recalls or safety alerts involving 408,500 cardiac pacemakers and 114,645 implantable cardioverter-defibrillators between 1990 and 2000. Ninety-five percent of the recalls were caused by hardware malfunctions or computer errors.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 2001
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Safety Alerts Involving Device Therapy for Arrhythmias
Article Abstract:
More extensive testing of pacemakers and implantable cardioverter-defibrillators is needed before they are sold to the public. Between 1997 and 2000, the number of recalls of these devices increased substantially, affecting between 10% and 20% of all patients.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 2001
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Recalls and safety alerts affecting automated external defibrillators
Article Abstract:
A study was conducted to determine the number and rate of automated external defibrillators (AED) safety alerts and recalls, to identify the types of malfunctions prompting AED advisories, and to identify trends in AED performance. It was found that actual AED malfunctions do occur occasionally, although the number is small compared to the number of lives saved. Efforts to develop a reliable system by timely location and repair of defective devices are recommended, since AED advisories occur frequently.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 2006
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