FDA Alerts Patients to Medtronic Pacemaker Recall - June 11, 2009.

The U.S. Food and Drug Administration is alerting patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. 

Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death.

There are more than 1.7 million Kappa or Sigma pacemakers implanted in patients throughout the world. Of those, only about 21,000 pacemakers are affected by this recall, most of which have been implanted in patients for five years or longer.

Medtronic Inc. issued a letter to physicians alerting them to this problem on May 18. The company communicated with patients via letter on May 27. 

The affected pacemakers are Kappa Series 600/700/900 and Sigma Series 100/200/300. Patients with these models of Kappa and Sigma pacemakers should determine if their pacemaker is part of this recall by contacting Medtronic.

Patients who have these recalled pacemakers and those who are unsure if their pacemakers are affected should follow up with their primary care physician or cardiologist.

Through standard medical device reporting requirements, the FDA became aware of possible problems and worked with the company to address them. The FDA classified this voluntary recall as Class I, indicating reasonable probability that the use of the device will cause serious adverse health consequences or death.

Medtronic Sprint Fidelis leads recalled - October 23, 2007 (newsinferno).

Medtronic suspended sales and recalled all unused Sprint Fidelis leads, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with defective Sprint Fidelis leads are being told to leave the components in place unless they fracture.

When Medtronic issued the Sprint Fidelis lead recall, it was estimated that about 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of having a defibrillator implanted. Apparently, it was a problem that the company had known about for months. Since it was introduced to the market in 2004, there have been 599 reports of lead fractures as of January 2007. And it seems as though the fracture problems became worse over time. In the first two months of 2006, there were 27 reports of the Sprint Fidelis lead fracturing. But in the first two months of 2007, there were 152 reports. And since January 10, 2007, there have been a staggering 1,030 reports of fractures.

Shortly after the Sprint Fidelis lead recall, it was learned that the FDA had not required extensive testing of the vital defibrillator component before it went on the market. Although the agency had required Medtronic to test an earlier version of a defibrillator lead in patients before approval, it had not required the company to do so for the defective Sprint Fidelis lead. That was because officials at the FDA had determined that the Sprint Fidelis lead was not a significant enough change from the design of its predecessor. Instead, the FDA required the Sprint Fidelis lead to pass only tests intended to identify design flaws. Those were principally mechanical stress tests meant to recreate the pressures in the body. The FDA is trying to figure out why those tests did not pick up the defects in the Sprint Fidelis lead.

Some medical experts have questioned the FDA’s decision not to put the defective Sprint Fidelis lead through more clinical tests. Though its predecessor, the Sprint Quattro, has a good performance history, the Sprint Fidelis lead is a significantly thinner wire. Many believe that thinness made the defective Sprint Fidelis lead more apt to fracture.

The issues that the Congressional Committee is investigating include the FDA’s decision not to subject the defective Sprint Fidelis lead to more rigorous testing, and why all defibrillator leads are not subject to the same level of scrutiny as the heart devices themselves.

Patients Warned as Maker Halts Sales of Heart Implant Part - October 15, 2007 (NYT).

The nation’s largest maker of implanted heart devices, Medtronic, said yesterday that it was urging doctors to stop using a crucial component in its most recent defibrillator models because it was prone to a defect that has caused malfunctions in hundreds of patients and may have contributed to five deaths..