HOW DEFIBRILLATORS WORK

Guidant Defibrillator Recall Information  |  Medtronic Defibrillator Recall Information

Implantable cardiac defibrillators (ICDs) are small devices, about the size of a pager, that are placed below the collarbone. A defibrillator can monitor heart rhythms, and deliver shocks if dangerous rhythms are detected.
 

Many ICDs record the heart’s electrical patterns whenever an abnormal heart beat occurs. Doctors can review this record during regular check-ups to help plan future treatment options.

Like a pacemaker, an ICD consists of a battery and electrical circuitry (pulse generator) connected to one or more insulated wires. The pulse generator and batteries are sealed together and implanted under the skin, usually near the shoulder. The wires are threaded through blood vessels from the ICD to the heart muscle.

The ICD continuously checks the heart rate. When it detects a too-rapid or irregular heartbeat, it delivers a shock that resets the heart to a more normal rate and electrical pattern (cardioversion). Sometimes the ICD can be programmed to “pace” the heart to restore its natural rhythm and avoid the need for a shock from the ICD. Pacing signals from the ICD are not felt by the patient; shock signals are, and have been described as a kick in the chest.

Stopping the potentially fatal fibrillation is called defibrillation.

Defibrillators have been very useful in preventing sudden death in patients with known, sustained ventricular tachycardia or fibrillation. However, recalls linked to ICD's are not uncommon, and with heart disease still the number one cause of death in the United States, the safety of these medical devices is of great concern.

In some cases, these surgically implanted defibrillators can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed. So, at the very moment when the patient's life depends on the reliability of the ICD, the device can malfunction.

Defibrillators that have a documented history of recalls and warnings from the FDA include:

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

VENTAK PRIZM AVT, VITALITY AVT, RENEWAL AVT Devices, CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF- Class II - FDA has classified the previous actions taken by Guidant for these devices as a Class II recall. 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.

Medtronic Defibrillator Recalls include:

• Model 7230 Marquis VR;
• Model 7274 Marquis DR;
• Model 7232 Maximo VR;
• Model 7278 Maximo DR;
• Model 7277 InSync Marquis;
• Model 7289 InSync II Marquis;
• Model 7279 InSync III Marquis;
• Model 7285

FDA advises patients to take the following steps:

• If you have not already been notified, contact your doctor to determine if you have an affected PRIZM 2, CONTAK RENEWAL, or CONTAK RENEWAL 2 device.
• Continue to keep your regular doctor appointments.
• If you feel an electrical shock from your device, immediately contact your doctor.
• If there is an audible "beeping" from your CONTAK RENEWAL or RENEWAL 2 device, immediately contact your doctor or go to the nearest emergency room. Beeping may mean that your defibrillator is damaged.

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