[H185]Health Problems In Canada

ICDs can generate (1) a series of precisely timed low-intensity electrical pulses to reset the heart to normal rhythm when the heartbeat becomes faster than normal (ventricular tachycardia), and (2) electric shocks that may feel like a sudden kick in the chest to stop potentially fatal quivering of the heart (ventricular fibrillation).

In addition, the ICD may be programmed to work as a pacemaker and send small electrical signals to pace the heart whenever it detects an abnormally low heartbeat (bradycardia).

These electronic medical devices are placed in the body to prevent cardiac arrest from severe ventricular tachycardia. The defibrillator works by connecting a small electrode between the heart and a computer in the device. This device monitors the heartbeat and if it detects an arrhythmia, it activates a built-in pacemaker to stabilize the heart rate. If this fails, the defibrillator sends a jolt to the heart.
ICDs are among the fastest-growing group of medical devices; in the year 2005 alone, more than 200,000 patients are expected to have one implanted. An ICD can cost up to $25,000 for the device itself and uncomplicated hospital and doctor costs can run another $15,000 to $25,000.

If the device does not work, death can occur from the failing condition of the patient. Medtronic allegedly knew of the defects in their defibrillators before they were sold for implantation in thousands of patients. Medtronic has recalled approximately 65,000 defective devices. Defects in Medtronic devices include internal short circuits, memory errors, and problems with magnetic switching. ICDs are used to shock the heart into normal rhythm after a patient suffers ventricular tachycardia or fibrillation, which are rapid, life-threatening arrhythmias originating in the lower chambers of the heart. Some of the defibrillators failed to charge properly, resulting in late or non-delivery of cardiac shock therapy.

FDA Recalls Defective Medtronic ICDs

In April 2004, Medtronic announced a recall of two implantable cardioverter-defibrillators which had been linked to four deaths and a serious injury. The recall affected the Micro Jewel II Model 7223Cx and the GEM DR Model 7271 implanted cardioverter-defibrillators, most of which were implanted between 1997 and 1998. There were thought to be about 1,800 of these units in use at the time.

On February 11, 2005, the Food and Drug Administration (FDA) announced that Medtronic was recalling certain ICDs due to a battery shorting defect which results in rapid battery depletion leading to loss of device function. Devices with batteries manufactured between April 2001 and December 2003 may exhibit this shorting action. Thus in February 2005, Medtronic announced that two types of its devices, ICDs and "cardiac resynchronization therapy defibrillators" (CRT-Ds) may experience battery shorts.

The affected defibrillators include the following: Marquis VR/DR Iand Maximo VR/DR ICDs and the InSync I/II/III Marquis and InSync III Protect CRT-D lines, manufactured between April 2001 and December 2003. CRT-Ds are implantable devices used to treat heart failure and other life-threatening heart rhythm disturbances by delivering electrical impulses to the heart.

On June 21, 2005, the FDA criticized Medtronic's procedures for following up on complaints about an external defibrillator, including a failure to properly investigate a patient's death. This letter focused on damaged cable connectors in the devices, which are designed to deliver a powerful shock to patients experiencing sudden cardiac arrest. The damaged cables can cause the wrong amount of power to be delivered. The problems highlighted in the letter "may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems."

FDA Warning

The FDA has advised patients to take the following steps:

* Contact your doctor to determine if you have an affected ICD.

* Contact your doctor if you feel an electrical shock from your device.

* Contact your doctor or go to the nearest emergency room if you hear an audible "beeping" from your ICD.

Medtronic and Litigation

On December 7, 2005, all federal court cases were consolidated and transferred to the Hon. James M. Rosenbaum in the District of Minnesota for further pre-trial proceedings.