Guidant: Stop Using Some of Its Defibrillators
Guidant: Stop Using Some of Its Defibrillators
Firm Tells Doctors to Halt Use of Certain Devices Until Further Notice
June 24, 2005 -- Guidant Corporation is telling doctors to discontinue use of certain of its implantable heart devices.
This is just as a precautionary measure until further notice. The FDA may classify this action as a recall, they write.
The devices are the Contak Renewal 3 and 4, the Renewal 3 and 4 AVT, and the Renewal RF.
"We have determined that a magnetic switch in these devices may become stuck in the closed position," says a Guidant news release. That problem could hinder the device's ability to treat irregular heartbeats and could speed up the depletion of the device's battery, says Guidant.
Defibrillators are surgically implanted in people who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm). The devices are designed to deliver an electrical shock to the heart to restore normal heart rhythm.
Four cases have been confirmed out of about 46,000 of the devices. A fifth is suspected but cannot be confirmed, says Guidant.
In four cases, the device had been implanted; in another, the problem was caught before the device was used.
"In the four occurrences in which the device was implanted, patients and/or physicians were alerted to the condition by audible device tones that signaled the magnetic switch was closed," says Guidant. All of those devices were replaced.
Guidant: Stop Using Some of Its Defibrillators
Firm Tells Doctors to Halt Use of Certain Devices Until Further Notice
June 24, 2005 -- Guidant Corporation is telling doctors to discontinue use of certain of its implantable heart devices.
This is just as a precautionary measure until further notice. The FDA may classify this action as a recall, they write.
The devices are the Contak Renewal 3 and 4, the Renewal 3 and 4 AVT, and the Renewal RF.
"We have determined that a magnetic switch in these devices may become stuck in the closed position," says a Guidant news release. That problem could hinder the device's ability to treat irregular heartbeats and could speed up the depletion of the device's battery, says Guidant.
Defibrillators are surgically implanted in people who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm). The devices are designed to deliver an electrical shock to the heart to restore normal heart rhythm.
4 Confirmed Cases
Four cases have been confirmed out of about 46,000 of the devices. A fifth is suspected but cannot be confirmed, says Guidant.
In four cases, the device had been implanted; in another, the problem was caught before the device was used.
"In the four occurrences in which the device was implanted, patients and/or physicians were alerted to the condition by audible device tones that signaled the magnetic switch was closed," says Guidant. All of those devices were replaced.
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