Florida Personal Injury and Wrongful Death Blog

Manufacturer Warns Heart Patients of Faulty Defibrillators

News was released recently  that 3 implantable heart defibrillators made by Boston Scientific, the 2nd largest maker of heart devices, have problems which can prevent the devices from performing life-saving functions for heart patients.

The defibrillators, also known as ICD's, are implanted in patients in danger of sudden cardiac death. The device which is a small battery powered electrical impulse generator is intended to recognize cardiac arrhythmia and correct it by delivering a jolt of electricity.

Over the last several years they have been plagued with regulatory and product issues. The affected models are:

• Renewal 3
• Renewal 4
• Vitality HE

The company said their quality monitoring system detected the "somewhat higher rate of switch failure". To address the concerns they issued an advisory and posted an open letter to physicians on their website this week detailing the problem:

Dear Doctor,

This letter provides important patient management information regarding certain Boston Scientific CRT-Ds and ICDs manufactured between January 2006 and November 2007. In rare instances, application of a magnet (typically in a clinic/hospital environment) may cause a magnetic reed switch located within the device to become permanently stuck in a closed position and prevent delivery of programmed tachy therapy. No patient deaths or injuries beyond device replacement have been reported as a result of this issue. CRT-Ds and ICDs currently being distributed are not subject to this advisory.

Physicians are not being advised to replace the estimated 38,000 devices which are implanted in patients worldwide. Approximately 26,000 patients in the United States are affected. Rather they should continue to schedule routine follow-ups. The company believes that the risk of patient harm is less than one in one million devices. Patients should expect to hear an audible beeping tone if a problem does occur. In the event of that transpiring, Boston Scientific is advising patients to go to a hospital emergency center.

According to CNN, just 5 months ago Boston Scientific stopped U.S. shipments of all of its ICDs because they failed to submit proper documents on manufacturing changes to U.S. regulators. It resumed sales in April after getting approval from the U.S. Food and Drug Administration.