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GUIDANT DEFIBRILLATOR RECALL CLASSIFICATIONS

Guidant defibrillator recall: US FDA makes three classifications

BY OUR PHARMA CORRESPONDENT

 

2 July, 2005: In the continuing story of Guidant Corporation defribillator recall, US Food and Drug Administration has now classified the recalled implantable defibrillators according to safety and risks. FDA says that this extra information on the relative health risks of the defibrillators will help patients and the mecixal fraternity take proper action, whenever necessary.

US FDA has requested that physicians support Guidant's efforts to acquire additional information about the performance of these devices. Specifically, FDA has directed doctors to test these devices at the time they are no longer in service and if possible to return the devices to the manufacturer for analysis.

The FDA classifications are based on the probability that the device failure could lead to adverse health effects. According to Daniel Schultz, MD, Director of FDA's Center for Devices and Radiological Health, "malfunctions in defibrillators can lead trigger serious consequences and it's important for patients to talk to their physician for additional information and personalised advice. In most cases, these defibrillators work well and save lives."

The following is a complete list of the 11 devices affected by this recall
classification:

PRIZM 2 DR, CONTAK RENEWAL, and CONTAK RENEWAL 2 Devices- Class I

FDA has classified the actions taken by Guidant for some of their
defibrillators as Class I recalls. In a Class I recall, there is a
reasonable probability that if a particular device is malfunctioning, that device will cause serious adverse health consequences, and can even be fatal.

The Guidant investigation found that these implantable defbrillators can develop a short circuit when trying to deliver an electrical shock to the heart, which prevents the treatment of abnormal heart rhythms. This is caused by deterioration of electrical insulation and can only be detected after the device has already malfunctioned. There is no advance warning that the device is going to fail. 

A recall which comes under Class I does not necessarily call for removal of the
defibrillator. Under these recalls, Guidant is required to disclose the 
malfunction possibility while providing extra guidelines for safe use of the defibrillator. 

US FDA has not made any recommendation on whether those patients bearing one of these devices should have it removed and replaced. According to an FDA press statement, this decision has to be made by the patient and the doctor.

Guidant's recommendations on the safe use of the defbrillator include:

1. If you are not sure which model you have, or if you have other questions regarding your device, you should consult with your physician.
2. Continue to keep your normal doctor appointments.
3. If you feel a shock, contact your doctor as soon as possible.
4. 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- Class II

The recall of the devices mentioned above has been named by FDA as a Class II recall. In this category, the malfunctioning defibrillator may cause temporary or medically reversible adverse health consequences, however, the probability of serious adverse health consequences is remote. The problem here with the devices is a memory error which, in remote cases, may limit available therapy. Of the 21,000 defibrillators implanted worldwide, two incidents have been confirmed, neither of which resulted in death or injury. The fault can be detected by evaluating the device and Guidant has recommended that the device be
reprogrammed during a visit to the doctor. 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- Class II

FDA has categorised Guidant's previous actions regarding these devices as a Class II recall. These Guidant defibrillators are subject to a component failure which may, in rare cases, limit available therapy. A magnetic switch in these defibrillators 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, In this case, Guidant has suggested that doctors 
discontinue using these devices. For those defibrilators 
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.


BY OUR PHARMA CORRESPONDENT 

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