An implantable defibrillator (ICD) is a device that is implanted into the chest to monitor and, if necessary, correct episodes of heart rhythm disturbances (arrhythmias).

DCI can produce (1) a series of pulses of low intensity electrical exactly in the normal rhythm of the heart when the heart beat faster than normal (ventricular tachycardia) is reset calculated, and (2) electrical discharges that can feel like a kick chest shot to stop potentially deadly earthquakes of the heart (ventricular fibrillation).

In addition, the ICD programmed as a pacemaker function and send small electrical signals to the heart when it detects an abnormally low heart rate (bradycardia) pace.

This will prevent electronic medical devices in the body to cardiac arrest with severe ventricular tachycardia. The defibrillator works by attaching 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 it fails, the defibrillator sends a shock to the heart.
ICDs are among the fastest growing group of medical devices in 2005 alone over 200,000 patients have an implementation. An ICD can cost up to 000 Euro for the device itself and to the hospital without medical complications and costs, another run, 000 to 000th

If the device does not work, death can occur from the failing state of the patient. Medtronic would have known defects in its defibrillators, before they are sold for implantation in thousands of patients. Medtronic has recalled about 65,000 defective units. Defects in Medtronic devices include internal short circuits, memory errors and problems of the magnetic circuit. ICDs are used for the heart to normal rhythm after patients ventricular tachycardia or ventricular fibrillation, a rapid, life-threatening heart rhythm disturbances originating in the lower chambers of the heart, suffering shock. Some of the defibrillators do not charge properly, which in late or non delivery of cardiac shock therapy.

FDA recalls faulty Medtronic ICDs

In April 2004, Medtronic announced the recall of two implantable defibrillator carrier, which had four deaths and serious injuries linked. The recall affects Micro Jewel II Model 7223Cx and GEM DR Model 7271 implanted defibrillator, implanted by which most of them between 1997 and 1998. There were about 1,800 of these devices in use at the time thought.

On 11 February 2005, the Food and Drug Administration (FDA), the Medtronic recalling ICDs because of an error on some of the battery short circuit, the exhaustion of the battery leads, a rapid loss of function of the device lead. Devices with batteries between April 2001 and December 2003 can be made present these measures in the short circuit. In February 2005 announced Medtronic that two of its aircraft, DCI and cardiac resynchronization therapy defibrillators (CRT-D), the battery shorts experience.

Defibrillators are affected: Marquis VR / DR and Maximo VR I / DR ICDs and the InSync I / II / III Marquis and InSync III Protect CRT-D lines, which produced between April 2001 and December 2003. CRT-Ds are implantable devices for heart failure and other life-threatening heart rhythm disturbances treated by providing electrical pulses to the heart.

On 21 June 2005, the FDA criticized the method of Medtronic for tracking complaints about an external defibrillator, including the lack of properly investigating the death of a patient. This letter focuses on the damaged cable connectors in the devices that are designed to deliver a powerful shock to patients with cardiac arrest. The damaged cable can cause the wrong amount of power. The questions raised in the letter “may be symptomatic of serious problems in the production of your business systems and quality assurance.”

FDA warning

The FDA advised patients to take the following measures:

* Ask your doctor if you have affected an ICD.

Contact your doctor if you experience an electrical shock from your device.

Ask your doctor or go to the emergency room when you hear an audible “beep” from your ICD.

Medtronic and

Litigation
On 7 December 2005, all cases are consolidated for the Supreme Court and the Hon James M. Rosenbaum in the District of Minnesota for custody other methods.


Medtronic Pacemaker