FDA ISSUES HIGHEST LEVEL (CLASS I) WARNING REGARDING HEALTH RISKS ASSOCIATED WITH THREE OF THE RECALLED GUIDANT IMPLANTABLE DEFIBRILLATOR MODELS AS WELL AS A CLASS II WARNING AS TO EIGHT OTHER MODELSJul 2, 2005 | www.Newsinferno.com
The purpose of an implanted defibrillator is to shock an irregularly beating heart back into proper rhythm. If that is not done, death will result within minutes. For this reason, any defect or malfunction involving such a device is extremely serious.
On Friday, the FDA issued a series of Class I, II, and III warnings (recall classifications) with respect to the 11 models of implantable defibrillators that have been recalled by Guidant Corporation. The warnings apply to those devices which are still implanted and are classified in terms of “probability that the device failure could lead to adverse health effects.”
While the FDA is not recommending the removal of any device that is already in use, it has made it clear that the risks associated with the various recalled defibrillator models are quite serious. Affected individuals are urged to contact their doctors to discuss and decide upon the best course of action for them.
PRIZM 2 DR, CONTAK RENEWAL, and CONTAK RENEWAL 2 Devices
In a Class I recall, there is a reasonable probability that if a particular device is malfunctioning, the malfunctioning device will cause serious adverse health consequences or death.
The FDA has classified the actions taken by Guidant for these models of their defibrillators as Class I recalls.
Guidant has determined these devices can develop an internal short circuit when attempting to deliver an electrical shock to the heart, preventing the treatment of abnormal heart rhythms. The problem is caused by deterioration of electrical insulation in the device and can only be detected after the device has already malfunctioned.
The device does not give any sign of impending failure and there is no test that predicts whether the device will fail.
There have been two deaths reported to the FDA associated with these 42,000 affected devices worldwide (20,600 are still implanted).
The affected devices are:
• PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
• CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
• CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004
“A Class I recall designation does not necessarily require removal of the defibrillator. These recalls require Guidant to disclose the device malfunction to patients and doctors while providing additional instructions for safe use of the devices.”
The FDA is not recommending the removal and replacement of these models. “FDA believes that this decision must be made by the patient in consultation with his or her physician, based on the specific medical situation of the patient.”
Replacement of the device may pose some risk, so it is important that patients and physicians carefully discuss this matter before making a decision.
Guidant previously informed patients and physicians about the defibrillator problems and has provided additional instructions for safe use of the devices. Guidant’s recommendations include:
• If you are not sure which model you have, or if you have other questions regarding your device, you should consult with your physician.
• Continue to keep your normal doctor appointments.
• If you feel a shock, contact your doctor as soon as possible.
• If you or others hear “beeping” from your device, go immediately to your doctor or the emergency room.
VENTAK PRIZM AVT, VITALITY AVT, and RENEWAL AVT Devices
For a Class II recall, the malfunctioning product may cause temporary or medically reversible adverse health consequences, however the probability of serious adverse health consequences is remote.
The FDA has classified the actions taken by Guidant for these models of their defibrillators as Class II recalls.
These Guidant devices are subject to a memory error which, in rare cases, may limit available therapy. Of the 21,000 devices implanted worldwide (18,000 in the U.S.), two incidents have been confirmed, neither of which resulted in death or injury.
The defect can be detected by medical evaluation of the device and Guidant is recommending the device be reprogrammed during the patient’s next doctor visit. Guidant is developing an additional non-invasive software solution for this problem, which is expected by the end of the year.
CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF Devices
The FDA has classified the previous actions taken by Guidant regarding these devices as a Class II recall.
“These devices are subject to a component failure that in rare cases may limit available therapy. A magnetic switch in these devices may become stuck in the closed position, which in some cases inhibits the device’s ability to treat ventricular or atrial tachyarrhythmias (abnormally fast heart rhythms) and also accelerates battery depletion.”
Four occurrences have been confirmed out of approximately 46,000 devices; a fifth occurrence is suspected but cannot be confirmed. “In the four confirmed cases, patients and/or physicians were alerted to the condition by audible device tones signaling that the magnetic switch was closed. Based on this information, it is important that patients who hear tones from their device immediately contact their physician or go to the hospital emergency room.”
As a precautionary measure, Guidant has recommended that physicians discontinue implanting these devices until further notice. For devices already implanted, Guidant has recommended that physicians change “Enable Magnet Use” to “OFF.” This will ensure appropriate therapy to treat the patient’s abnormally fast heart rhythm.
The FDA has requested physicians support Guidant’s efforts to acquire additional information about the performance of these devices. Specifically, the FDA has asked doctors to test these devices at the time they are no longer in service and, if possible, return them to the manufacturer for analysis.
Physicians or patients who have experienced a problem with any of the affected defibrillator models should send a report to the FDA's MedWatch program and to Guidant.
See http://www.fda.gov/medwatch/index.html for filing information or call 1-800-FDA-1088 (1-800-332-1088).
Guidant has posted information for patients and physicians on its web site at http://guidant.com/physician_communications/.
If you have further questions, you may contact Guidant at 1-866-GUIDANT (1-866-484-3268).
On May 24, Guidant disclosed it had waited three years before disclosing it had been aware of an electrical problem that had caused some 28 of 28,900 Ventak Prizm 2 DR defibrillators to malfunction. The death of a 21-year-old college student was associated with this model.
As the story developed, the number of potentially defective defibrillators still in use reached almost 50,000; the 28,900 with the electrical problem and another 21,000 which could malfunction due to a computer memory error (the Vertak Prizm AVT, Vitality AVT, Renewal 3 AVT, and Renewal 4 AVT ICD). .
A third problem then came to light with respect to another potential short-circuit risk associated with the Contak Renewal (Model H135) and the Comtak Renewal 2 (Model H155). Out of those 16,000 devices, 15 reports of failures had been received including one involving a death on May 30. As a result, Guidant issued recalls for all of these devices on June 18.
c Those models are the Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF.
Guidant advised doctors to stop implanting these devices until further notice. Currently, however, some 46,000 of them are already in use.
Guidant acknowledged the FDA may classify this advisory as a recall. Although no deaths have been reported, as many as five devices have malfunctioned.
Many experts openly questioned a monitoring system which essentially leaves the question of disclosure, with respect to potential flaws in such critical medical devices, entirely to the manufacturer.
As a result, the Heart Rhythm Society will prepare a set of guidelines with respect to physician alerts and other actions that should be taken by defibrillator makers when they identify a pattern of malfunctions in the devices even if those failures are rare. The Society represents a branch of cardiology known as electrophysiology and is made up of cardiologists who specialize in implanting defibrillators.