FDA Issues Report on ICD and Pacemaker Malfunctions

Following the recent recalls of nearly 150,000 implantable cardioverter defibrillators (ICDs) and cardiac pacemakers, FDA's Center for Devices and Radiological Health (CDRH; Rockville, MD) released the findings of a major study on the malfunction of cardiac rhythm management devices. The report covers the likely causes and incidence of device failure, as well as ways to improve device monitoring and public communications. The results were presented in mid September at the "Policy Conference on Pacemaker and ICD Performance," sponsored by the Heart Rhythm Society (Washington, DC).

FDA's Gottlieb: Addressing the challenge.

The findings of the study were presented by Scott Gottlieb, MD, FDA deputy commissioner for scientific and medical affairs. "Pacemakers and ICDs have saved many lives and the benefits of the devices clearly outweigh the risks," Gottlieb said. "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."

The study characterized ICDs and pacemakers as "generally safe and effective devices" and noted that the number of patients receiving such implants has increased substantially in recent years. But FDA expressed concern with the study's findings that the malfunction replacement rate for ICDs was significantly higher than the malfunction replacement rate for pacemakers, and that the ICD malfunction replacement rate appeared to be increasing.

The study covered the period from 1990 to 2002, during which 2.25 million pacemakers and 416,000 ICDs were implanted in U.S. patients. When asked why the study didn't include more recent data, FDA said that 2002 was the last year for which complete information was available.

During the period covered by the study, 8834 pacemakers and 8489 ICDs were removed from patients due to malfunction. The annual average ICD malfunction replacement rate was 20.7 per 1000 implants, with a range of 7.9 to 38.6. This was significantly higher than the annual average pacemaker malfunction replacement rate of 4.6 per 1000 implants, with a reported range of 1.4 to 9.0. This rate for pacemakers decreased significantly during the study period. The malfunction replacement rate for ICDs, however, declined during the first half of the 1990s, but increased through 2002. More than 50% of the ICD failures occurred during 2000–2002, the last three years of the study.

All together, approximately 2.67 million cardiac rhythm management devices were implanted during the study's time frame, during which 61 deaths were attributed to device failure. According to the FDA report, "the vast majority of reported malfunctions did not lead to death or serious injury, and were detected in time to ensure that patients would continue to receive therapy when it was needed."

Battery, capacitor, and other electrical issues were found to be the most common causes of device failure. The reason for the disparity between malfunction rates for ICDs and pacemakers was not firmly established, but FDA cited "increased complexity of these devices, manufacturing challenges posed by device complexity, or increased reporting by physicians" as likely contributors. The report noted that ICDs continue to incorporate advanced technologies, greater memory, and more therapeutic features. At the same time, the devices have been decreasing in size. This has necessitated design modifications to the battery, capacitor, and overall circuitry, which may have also contributed to the malfunctions.

The study emphasized the need for more careful monitoring of device performance, along with better ways for doctors to return removed malfunctioning devices to the manufacturer for analysis and for preparing adverse event reports to be sent to CDRH. In its effort to improve device monitoring and issue earlier communications to physicians and patients, the agency cited the following priorities.

• Increase CDRH's ability to obtain information about device failures and rapidly communicate it to physicians and the public for sound medical decisions.

• Improve distribution and coordination of manufacturers' annual reports within CDRH to allow for a more integrated, efficient, and timely review.

• Establish a working task group within CDRH so that problems with ICDs and pacemakers can be quickly reviewed and evaluated by staff, and shared more rapidly with physicians and the public.

In addition, the agency indicated that it intended to implement a number of operational changes that had been recommended as part of a review of postmarket programs at CDRH. Key projects to be implemented would include the following.

• Design an electronic system for adverse event reporting to make the information available to CDRH analysts more quickly.

• Target agency resources toward inspections of firms that manufacture potentially higher risk devices.

• Develop guidance about the need for detailed device-failure information in manufacturers' annual reports to FDA.

• Develop guidance that more clearly defines when changes to devices need prior FDA review and approval before being implemented by the manufacturer.

CDRH's Schultz: Progress under way.

CDRH director Daniel Schultz, MD, said that the report points out the need for the agency to improve the way it regulates pacemakers and ICD devices. "We have already begun to better coordinate our pre- and postmarket regulation of these devices, to strengthen the link between how these products are approved and how they are monitored after clinical use," said Schultz. "We are also considering whether we need additional data from manufacturers in their annual reports, and how we can communicate more effectively with physicians and patients when these devices malfunction."

The policy conference was billed as "a productive forum among physicians, other healthcare providers, the medical device industry, government agencies, and the public to discuss the current process for ICD and pacemaker recalls and communication of device performance." Organizers indicated that the conference would place emphasis on exploring alternatives and recommending improvements to current policies.

Nevertheless, the process of developing and implementing new procedures for reporting ICD and pacemaker failures may be a lengthy one. "This conference was the start of a dialogue," says Mark Brager, director of communications at industry association AdvaMed (Washington, DC). "I don’t think anyone expected the conference to result in any final recommendations that could be implemented right away." Brager says that AdvaMed already has a number of working groups that are dealing with proposed policy and procedural changes for the field. "These groups are formed when issues arise that require concentrated industry attention," says Brager. "Some of the working groups dealing with the HRS issues have been fairly active recently addressing other related issues."

As a basis for further discussion, the Heart Rhythm Society expects to publish the proceedings of the conference later this year.

The FDA study was widely reported in both the business and general press. The study focused exclusively on cardiac rhythm devices, such as pacemakers and ICDs, but coverage of the report often cast it in a much broader light. For example, one headline read, "FDA to Seek Greater Control of Medical Devices." Indeed, many industry analysts believe that the same kind of agency oversight, Congressional intervention, and public scrutiny that has dominated the pharmaceutical industry in recent years will increasingly extend to medtech.

The full FDA report and supporting materials are available via the agency's Web site at: www.fda.gov/bbs/topics/news/2005/new01231.html.

Canon Communications LLC

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