Defective Medtronic Implantable Cardiac Defibrillators

Implantable Cardiac Defibrillators are devices placed in the body intended to prevent cardiac arrest from a severe irregular heart beat. A wire (lead) is attached to the heart and is connected to a miniature computer that contains its own power source that is placed under the skin usually in the area in the upper chest The device monitors the heart beat and is intended to react to changes in the heart beat. The built-in pacemaker replaces the hearts normal pacing system and restores normal heart rhythm. In some situations the device will deliver an electrical shock to the heart to whether restart or reset the heart rate.

Medtronic Incorporated

Medtronic refers to itself as the global leader in medical technology -alleviating pain, restoring health and extending life for millions of people around the world.

Marquis™ VR/DR and Maximo™ VR/DR ICDs and the InSync I/II/III Marquis™ and InSync III Protect

On February 11, 2005 -- Medtronic, Inc., recalled approximately 87,000 devices due to a potential battery shorting mechanism that may occur in implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models. In a letter to physicians, Medtronic reported that the defective devices have experienced rapid battery depletion due to this shorting action. If shorting occurs, battery depletion can take place within a few hours to a few days, after which there is loss of device function.

Devices with batteries manufactured between April 2001 and December 2003 may exhibit this shorting action. Potentially affected models are the Marquis™ VR/DR and Maximo™ VR/DR ICDs and the InSync I/II/III Marquis™ and InSync III Protect™ CRT-D devices. Approximately 75 percent of these devices were implanted in the United States. Patients with other models of Medtronic devices or these device models with batteries manufactured after December 2003 are not affected.

Although, Medtronic was aware of the defect and started to manufacture devices without the defect in December 2003 it continued to sell the older manufactured devices containing the defect and many of the devices with the defect were implanted in patients after December 2003 continuing up to the date of the recall.

What models are defective:

• Marquis VR 7230
• Marquis DR 7274
• Maximo VR 7232
• Maximo DR 7278
• InSync I Marquis
• InSync II Marquis
• InSync III Marquis
• InSync III Protect 7277
• InSync III Protect 7289

SIGMA

Approximately 28,000 active implants, with approximately 6,650 in the US, out of an initial implant population of 40,000 worldwide. Affected serial numbers are available online at http://SigmaSNList.medtronic.com. Sigma® series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or no output.

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