Guidant Corp. issued recalls Thursday for some of its best-selling pacemakers. Citing problems with the Insignia and Nexus families of implantable pacemakers, Guidant informed physicians that the devices may fail because of problems discovered by the U.S Food and Drug Administration (FDA).
Failures may result in an intermittent or permanent loss of pacing or telemetry, or the appearance of a reset warning message. According to Guidant, these failure modes can result in serious health complications. Although no known deaths have resulted from the failures, hospitalizations have occurred, and the company urged patients to consult with their doctors.
This recall affects over 50% of the company’s pacemaker products, and was due to a report issued by the FDA that included trend observations on the Insignia and Nexus pacemaker families. The report was filed when the FDA completed its most recent inspection of Guidant’s Cardiac Rhythm Management facilities in St. Paul, Minnesota. According to the FDA, a seal within the pacemaker devices can leak, allowing moisture to affect the electronic circuits. The problem can occur without warning and can lead to loss of consciousness, and possibly heart failure and death.
The following pacemaker models are affected by the Guidant recall. They were all 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
The FDA has classified Guidant’s recall as a Class I recall, meaning that there is a reasonable probability that the malfunctioning device will cause serious adverse health consequences or death.
While the failures can occur without warning, sometimes a malfunction can be detected by a physician before it 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.
As of July 11, 2005, Guidant had received reports that 69 pacemakers may have failed due to the leakage. 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.
This recall follows the June 17th, 2005 recall of 50,000 Guidant Implantable Cardiac Defibrillators, due to faulty insulation in the wiring. Defibrillators, used primarily by people who suffer from arrhythmia or an irregular heartbeat, are designed to electrically stimulate the heart. Guidant announced a second defibrillator recall on July 19th, affecting over 25,000 patients.
Joint research done by the Food and Drug Administration and Harvard Medical School, indicates that the number of defects in implantable defibrillators is rising quickly. According to William Maisel of Harvard Medical School, it is the recent increase of faulty devices that is troubling. More than half of the defects throughout their 12-year study occurred within the last three years.
According to the study, defibrillator replacements due to these defects has not kept pace with the recalls, indicating that more needs to be done to assist patients and doctors in the replacement of the faulty and life-threatening devices.
Congress is also taking a hard look at Guidant and how the FDA is monitoring the recalls. Senator Charles E. Grassley, Chairman of the Senate Finance Committee, has requested information from the FDA concerning the faulty defibrillators. In his letter of July 20th, he cites the death of a young college student whose implantable defibrillator failed due to a short circuit.
Joshua Oukrop, a 21-year-old student who suffered from a genetic heart disease, died earlier this year when his Guidant Prizm 2 defibrillator short-circuited while he was biking. A month later, Guidant began notifying doctors of the electrical flaw.
Senator Grassley requested post-approval reports for the recalled heart devices and an update on the steps the FDA and Guidant are taking to establish guidelines for device surveillance and the dissemination of information to both physicians and patients.
Grassley has long been an advocate of dissemination of post-approval information on drugs and their possible harmful side effects. He and Senator Christopher Dodd (D-Conn) have introduced legislation that would create a national data bank of clinical information, and have written a bill which would establish an independent drug safety office within the FDA. This office would regulate drugs once they are on the market.
It is not clear if Senator Grassley will call for hearings on Guidant’s recalls, but his staff left the door open for that possibility.