Featured Defective Medical Devices

Defective Defibrillators and Pacemakers

An implantable cardioverter defibrillator (ICD) is used in patients at risk for recurrent, sustained ventricular tachycardia or fibrillation. The defibrillators are intended to deliver a shock to the heart to restore normal heart rhythm. The device is connected to leads positioned inside the heart or on its surface. These leads are used to deliver electrical shocks, sense the cardiac rhythm and sometimes pace the heart, as needed. Prior to delivering the shock, the device analyzes the patient’s heart rhythm to determine if a shock is appropriate. Newer devices are smaller and have simpler lead systems.

Medtronic Defibrillator Recall

In April 16, 2004 Medtronic announced that it was recalling two heart defibrillators because they have been associated with at least four deaths and one injury. Medtronic said that some of these defibrillators have failed to charge properly which can result in the late delivery or no delivery of cardiac shock therapy. Medtronic Inc. is the leading maker of implantable cardioverter defibrillators (ICDs) and pacemakers.

Troubles among patients who had received devices containing the defective batteries were first reported in the spring of 2004, after a failed ICD that had been removed from a patient was returned to the company for analysis. Physicians revealed six of the nine reported failed batteries because of Medtronic defective defibrillators during patient visits. The FDA classified the recall a Class I recall, meaning there was a situation in which reasonable probability that the use of or exposure to the product would cause serious adverse health consequences or death.

ICD Risks

Serious complications during ICD implant surgery:

• Torn blood vessels
• Severe bruising or bleeding
• Air intrusion between lungs and the chest wall
• Heart attack
• Stroke
• Electrical storm
• Puncture of lung or heart muscle
• Death