Heart News

Rise in Recalls and Safety Alerts Involving Pacemakers and Implantable Cardioverter Defibrillator (ICD) Generators

A recent study reported in the August 15, 2001 issue of JAMA, reports that there were 52 advisories (ranging from alerts to recalls) from January 1990 and December 2000, with the annual rate increasing since 1995. This resulted in more than 500,000 permanent pacemaker and ICD generators being checked or replaced in the United States with a cost of $870 million dollars.

This study looked at the FDA's weekly Enforcement Reports to obtain numbers of the recalls and safety alerts in the United States from January 1990 through December 2000. Only advisories affecting pacemaker or ICD pulse generators were reviewed; advisories regarding leads were excluded from the study. Rates of annual prevalence of patients with devices was extrapolated using numbers obtained from the 1990s, rate of new implants, and numbers obtained by the US Census.

Results:

• The number of patients with implanted devices has increased 49 percent from 1990 to 2000. The number of ICDs has increased more than the number of pacemakers.
• There were 52 advisories. Recalls and safety alerts more often involved pacemakers, the annual percentage of advisories involving ICDs increased.
• Three fourths of the advisories were class I or II advisories.

• Class I = reasonable probability that failure of the product would cause serious adverse health consequences or death.
• Class II = Use of product that failed may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote. 95 percent of advisories were related to hardware or firmware (computer programming) errors.

• Pacemaker advisories required device check and analysis. Over 1.2 million pacemaker checks and analyses were recommended, mostly because those devices that were not replaced required monthly checks. Replacement of the device was more often recommended for ICDs.
• Total advisory costs were estimated to exceed 500 million based on replacement costs, analyses, and physician costs.

Dr. William Maisel et. Al relates these findings to several factors:

• There is an increase in the number of pacemakers and ICDs implanted 49 percent from 1990 to 2000. This is related to an increase in the aging population, in the number of indications for pacing and studies proving the survival benefit of ICDs in specific high-risk patients.
• There have been a limited number of registries tracking devices and these have been voluntary. There has been an increase in the vigilance of manufacturers and the FDA to track device safety.
• Devices are more complex, allowing for improved battery life, programming, conduction and diagnostic capabilities. This increase in technical complexity may lead to more safety advisories related to processes, which are difficult to anticipate.
• ICDs are more likely associated with life threatening arrhythmias and therefore, would more likely be replaced rather than monitored.

Comments by Dr. Bruce Wilkoff, Cleveland Clinic Foundation Heart Center, Section of Electrophysiology:

Cardiac pacemakers and ICDs treat serious heart conditions and are remarkably reliable, however since patients depend on these devices it is important that these patient’s and their devices are closely monitored. The devices are increasingly complex and consequently there are more opportunity for one of the functions or components to malfunction.

Usually these advisories identify a problem, which will occur only occasionally and sometimes have never in fact happened. Even so, it is encouraging that the monitoring systems, through the FDA, the manufacturers, the hospitals and physicians have been able to recognize the problems. There is almost no reason to believe that many patients die or are seriously injured because of the malfunctioning of the devices. However the recognition of potentially troublesome issues are crucial since the patients and doctors depend on these devices to work well.

Patients should not be concerned about their pacemaker or ICD malfunctioning if they are having the device checked regularly in a pacemaker or device clinic by specialists . Usually pacemaker patients have their device checked every 3 months by telephone or in person. Defibrillator patients usually will have their device checked at least every 6 months.

Often, with or without a recall or safety alert patient’s and their device need to be followed more frequently. The frequency of testing depends on the patient’s condition, the type of device and how long the device has been implanted. Testing, in the device clinic, evaluates both the device and their leads.

Resources

Maisel WH, Sweeney MO, Stevenson WG, et al. Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators. JAMA 2001;286:793-99.

© Cleveland Clinic Foundation, 2008.