Implanted Heart Defibrillator Malfunctions Increase, FDA

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Main Category: Cardiovascular / Cardiology
Article Date: 17 Sep 2005 - 13:00 PDT

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In a report released yesterday, the FDA said there has been an increase in the number of Implantable Cardioverter Defibrillator (ICD) malfunctions during the period 1990 - 2002. On the other hand, the number of malfunctioning pacemakers removed and replaced in patients has decreased.

The FDA is not sure why the number of ICD malfunctions has increased - it suspects it may be 'related to the increased complexity of these devices, manufacturing challenges posed by device complexity, or increased reporting by physicians'.

The FDA said more careful monitoring of ICDs is needed - ways should be found for doctors to return explanted devices for analysis and to report adverse events.

Scott Gottlieb, MD, FDA Deputy Commissioner for Scientific and Medical Affairs, said "The FDA is committed to continuing to improve the quality of information that patients and doctors have to make decisions about the safe and effective use of these critical, life-saving technologies. Pacemakers and ICDs have saved many lives and the benefits of the devices clearly outweigh the risks. All sophisticated medical devices like these have certain risks. Our challenge remains to uncover these risks, measure them, and make information available to patients and doctors to help guide their personalized decisions about where the benefits of technologies like these outweigh known or potential risks from their use."

In the period 1990 - 2002

2.25 million pacemakers and 416,000 ICDs implanted in the USA
8834 Pacemakers and 8489 ICDs were removed from patients due to confirmed malfunction

ICD Malfunction Rate 1990 - 2002

20.7 per 1000 for ICDs (started dropping, then rose during last five years)
4.6 per 1000 for Pacemakers (steady decrease over this period)
Half of all ICD malfunctions happened during the last three years.

Deaths - Pacemakers and ICDs - 1990 - 2002

61 deaths out of nearly 3 million devices implanted
Most malfunctions did not lead to death.

See the study at:
fda.gov/cdrh/ocd/icd.

Written by Christian Nordqvist
Editor - Medical News Today
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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