The U.S. Food and Drug Administration (FDA) has upgraded a voluntary recall of certain Guidant pacemakers to a Class I recall, the most serious category. At least 69 pacemakers have reportedly failed and at least one death has been reported so far.
The problem involves a seal within the devices. It can leak, allowing moisture to affect the electronic circuits, causing the pacemaker to fail to provide pacing or causing a rapid heart rate. Other unexpected device behaviors are also possible. The problems may occur without warning and can lead to loss of consciousness, and possibly heart failure and death.
As of July 11, 2005, Guidant had received reports that 69 pacemakers may have failed because of the leakage. Twenty of the devices were confirmed to have stopped providing pacing output, resulting in loss of consciousness in five patients.
Guidant also received reports of two patients who had sustained pacing at a rapid rate. A patient whose device exhibited sustained pacing at a rapid rate was admitted to the hospital and later died. The device problem could not be confirmed as leakage since the device was not returned.
Only the following models are affected by this recall. All were manufactured between November 25, 1997 and October 26, 2000.
• PULSAR MAX Models 1170, 1171, 1270
• PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
• DISCOVERY Models 1174, 1175, 1273, 1274, 1275
• MERIDIAN Models 0476, 0976, 1176, 1276
• PULSAR MAX II Models 1180, 1181, 1280
• DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
• CONTAK TR Model 1241
• VIRTUS PLUS II
• Models 1380, 1480
• INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499
• VIRTUS PLUS II and INTELIS II models available only outside the U.S.
Guidant announced the initiation of a voluntary recall on July 18, 2005. The recall action consisted of a letter to physicians that describes the problem and provides recommendations about how to minimize the risk of pacemaker failure.
The FDA has reclassified Guidant's action as a Class I recall -- the most serious. These numerical classifications are based on the probability that the device failure could lead to adverse health effects. In a Class I recall, there is a reasonable probability that the malfunctioning device will cause serious adverse health consequences or death.
"Pacemakers are complex medical devices that can extend and improve the lives of many people who have heart rate abnormalities. However, they are not perfect and can malfunction," said Daniel Schultz, M.D., Director, FDA's Center for Devices and Radiological Health. "We are notifying patients and physicians about this important safety matter so they can take prompt action to reduce the risk of serious health consequences." Some patients are very dependent on pacemakers to maintain an adequate heart rate. For these patients, failure of the device to provide pacing output can cause sudden faintness or loss of consciousness, and can result in death. The leakage defect can also cause a sustained rapid heart rate, which can cause heart failure and result in death.While the failures can occur without warning, sometimes a physician can detect a leak-related malfunction before the malfunction causes serious problems. Guidant has provided information to physicians about ways to identify a leak-related malfunction. However, Guidant is not aware of any test that will show if a normally functioning pacemaker is likely to fail in the future.
Approximately 18,000 of the affected devices remain in service in the United States and an additional 10,000 are in service in other countries. Guidant estimates that the failure rate from the leakage defect will be between 0.17% and 0.51% (i.e., between 1.7 per one thousand and 5.1 per one thousand) over the remaining lifetime of the devices. It is possible that the actual failure rate will be greater than this, in part, because some past failures may not have been reported to Guidant.
The FDA concurs with Guidant's proposed recommendation to patients, which are consistent with the physician recommendations previously set forth in Guidant's July 18 letter:
• If you believe you are pacemaker dependent, contact your physician soon to discuss your treatment options.
• Continue your normal doctor appointments.
• If you experience symptoms of shortness of breath, dizziness, lightheadedness, loss of consciousness, or a prolonged fast heart rate, you should consult with your physician or go to the emergency room immediately.
• If you are not sure which model you have, or if you have other questions regarding your device, you should consult with your physician.
• If you know your device's model and serial number and want to find out if it is affected by the leakage problem, you can check www.guidant.com/webapp/emarketing/lookup.jsp or contact Guidant Technical Services at 1-866-GUIDANT (1-866-484-3268).
• If you are a physician or a patient who has experienced a problem with any of these pacemakers, please send a report to FDA's MedWatch program and to Guidant. See www.fda.gov/medwatch/ for filing information or call 1-800-FDA-1088 (1-800-332-1088).
