Defibrillators

The following Guidant implantable heart defibrillators and cardiac resynchronization therapy defibrillators are being recalled by Guidant Corporation:

• VENTAK 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.
• CONTAK RENEWAL 3, Model Number H170, H173 and H175
• CONTAK RENEWAL 3 HE, Model Numbers H177, H 179
• CONTAK RENEWAL 4, Model Numbers H190, H195
• CONTAK RENEWAL 4 HE, Model Numbers H197, H199
• CONTAK RENEWAL 3 AVT, Model Numbers M150, M155
• CONTAK RENEWAL 3 AVT HE, Model Number M157, M159
• CONTAK RENEWAL 4 AVT, Model Numbers M170, M175
• CONTAK RENEWAL 4 AVT HE, Model Numbers M177, M179
• RENEWAL RF, Model Numbers H230, H235
• RENEWAL RF HE, Model Number H239
• VENTAK PRIZM AVT, Model 1900
• VITALITY AVT, Model A135, A 155

These devices can either develop an internal short circuit without warning resulting in the devices failure to deliver a shock when needed or are subject to memory error.

The devices are implanted surgically in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia or abnormal rhythm. The devices are designed to deliver an electrical shock to restore the heart to a normal heart rhythm. The PRIZM 2 and RENEWAL devices are subject to a failure which prevents the devices from delivering an electrical shock during episodes of arrhythmia. The failure to deliver the electrical shock during an episode of arrhythmia could lead to a serious or life-threatening event for a patient. Forty-three failures have been reported to the FDA as a result of the defective nature of these two devices.

The Ventak Prizm 2, Model 1861, is implanted in approximately 24,000 patients. Following the death of a 21 year old college student, Guidant Corporation acknowledged that it was aware of 25 other cases in which the defibrillator had been affected with the same flaw. Guidant also indicated that it had known for one year that the Ventak Prizm 2, Model 1861, was defective. The Contact Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal AF are subject to a component failure that may limit available therapy. The magnetic switch in these devices may stick in a closed position.

The FDA is not making a recommendation on whether individual patients who have one of the Guidant devices should have it removed and replaced. This is a decision between the patient and his or her physician, based on that patient’s medical situation. Removal and replacement of the device may pose some risk, so it is very important that patients and physicians discuss this matter before making a decision.

The FDA is advising patients to take the following steps:

1. If you have not already been notified, contact your doctor to determine if you have an affected defibrillator or pacemaker.
2. Continue to keep your regular doctor appointments.
3. If you feel an electrical shock from your device, immediately contact your doctor.
4. If there is an audible “beeping” from your defibrillator device, immediately contact your doctor or go to the nearest emergency room. Beeping may mean your defibrillator is damaged.

Pacemakers

The following Guidant pacemakers have been recalled by Guidant Corporation:

• PULSARÒ MAX Models 1170, 1171, 1270
• PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
• DISCOVERYÒ Models 1174, 1175, 1273, 1274, 1275
• MERIDIANÒ 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 TRÒ Model 1241
• VIRTUS PLUSÒ II
• Models 1380, 1480
• INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499
• VIRTUS PLUS II and INTELIS II models available only outside the U.S.

On July 18, 2005 Guidant announced a voluntary recall of these pacemakers. The FDA upgraded Guidant’s voluntary recall to a CLASS I recall - the most serious of recalls. In a CLASS I recall, there is a reasonable probability that the malfunctioning device will cause serious adverse health consequences or death.

Heart disease remains one of the biggest killers in the United States. The Guidant devices are designed to extend the lives of heart disease patients. When the Guidant devices are defective and the proper therapy is not provided, the heart can cease functioning properly resulting in severe injuries or possibly death. It is Guidant’s responsibility to maintain the highest quality standards for their pacemakers.

Approximately 18,000 of the affected pacemaker devices remain in service in the United States. The FDA has recommended that if you are pacemaker dependent, you should:

1. Contact your physician soon to discuss your treatment options;
2. Continue your normal doctor appointments;
3. If you experience symptoms of shortness of breath, dizziness, lightheadedness, loss of consciousness, or a prolonged fast heart rate, you should consult with your physician or go to the emergency room immediately.

Mark Davis, P.C. is now handling claims for individuals with implanted Guidant defibrillators and Pacemakers manufactured by Guidant Corporation. Mark Davis, P.C. is experienced in medical device product liability cases and settlements. If you or a loved one has an implanted Guidant defibrillator or pacemaker, contact us at 1-800-277-0300. An attorney is standing by to assist you with your claim.