Guidant Defibrillators and Pacemakers

Munley, Munley and Cartwright is currently investigating cases involving the failure of Guidant Corporation defibrillators and pacemakers. Since June 2005, Guidant has recalled thousands of its medical devices.

On June 17, 2005, Guidant announced a recall of the following implantable cardiac defibrillators:

• 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

There are approximately 50,000 patients in the United States with one of these recalled defibrillators. Guidant Corporation has said that the devices have malfunctioned at least 45 times, causing two deaths. The malfunction that is the subject of the recall causes damage to the device?s circuitry, potentially resulting in the inability to deliver the required shock during episodes of arrhythmia. This malfunction could lead to a serious, life-threatening event. Importantly, the device does not give any sign of impending failure, and there is no test that predicts whether any particular device will fail.

On July 1, 2005, Guidant informed the FDA that it was recalling another set of defibrillators - the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT. The company has said the devices are subject to a memory error, which may affect device performance.

The FDA advises patients with any of the recalled defibrillators to keep their regular doctor appointments, and contact their doctors immediately if they feel an electrical shock from the device, or if there is an audible ?beeping? from their Contak Renewal or Renewal 2 device. Beeping may indicate that the defibrillator is damaged.

Two weeks later, on July 18, 2005, Guidant issued a warning about nine older models of its pacemakers because a hermetic sealing component used in the devices could leak, allowing moisture to affect the electronic circuits. This defect can cause the pacemakers to fail to provide pacing or can cause a rapid heart rate. The problems may occur without warning and can lead to loss of consciousness, and possibly heart failure and death.

The warning covers 28,000 pacemakers made between November 1997 and October 2000 and are still implanted in patients. Only the following models are affected by this recall. All were manufactured between November 25, 1997 and October 26, 2000:

• Pulsar? Max Models 1170, 1171, 1270
• Pulsar Models 0470, 0870, 0970, 0972, 1172, 1272
• Discovery? Models 1174, 1175, 1273, 1274, 1275
• Meridian? 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 TR? Model 1241
• Virtus Plus? II Models 1380, 1480
• Intelis II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499

Of the 78,000 pacemakers sold, 69 exhibited a problem, with five patients suffering dizziness or temporary loss of consciousness. The projected rate of failure for the implanted devices appears to be between 0.17 percent and 0.51 percent for the remaining life of the pacemaker.

Guidant has stated that it will cover the cost of a new pacemaker, plus $2,500 in any additional costs for replacement surgery beyond what Medicare or other health insurance would pay.

If you experience any of the symptoms related to Guidant defibrillators or pacemakers, you should consult with a physician promptly. Contact us if you believe you may have a claim for damages. Remember to leave your phone number if you wish to be contacted by telephone.