Congress Questions FDA about Medtronic Recall

posted on:
October 24, 2007

author:
Staff

One week after a Medtronic Defibrillator Lead recall was issued, the U.S. Congressional Committee on Oversight and Government Reform wants to know what the FDA knew and when they knew it. Approximately 235,000 people have the defective lead implanted with their cardiac defibrillator, and many now question whether the FDA and Medtronic could have prevented thousands of potentially fatal problems. 

On Monday, Representative Henry A. Waxman, chairman of the committee, sent a detailed letter to Andrew C. von Eschenbach, M.D., the commissioner of the U.S. Food and Drug Administration. He requested information about the approval process for the Medtronic Sprint Fidelis defibrillator lead and when the FDA first learned that the small wire could fracture, causing serious injury or death.

The Medtronic Sprint Fidelis lead is a small electrical wire which attaches to an implantable cardiac defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D). It runs through the veins and connects the defibrillator to the heart.

Defibrillators are designed to continuously monitor the heart's rhythm and issue a lifesaving jolt of electricity to restore a normal heart beat if it the rhythm is too fast or erratic. However, the Medtronic lead could erode or break, causing a defibrillator malfunction. As a result, the device could deliver a severe and unnecessary electrical shock to the heart or fail to work when it is needed.

According to Medtronic's own estimates, as many as 5,000 people will experience fractures in their leads within 30 months after the device is implanted. While physicians can reprogram the defibrillators to better detect a possible fracture, experts are not recommending that the leads be replaced. Any attempts to place a second lead in the chest or remove the existing lead from the veins could carry substantial risk of complications.

According to an article last week in the New York Times, the FDA did not requiring any testing for the Sprint Fidelis lead before allowing the lead wire to be implanted in people's chests. Although the lead is similar to an older version which had been tested, the Sprint Fidelis wire is much thinner which is likely what makes it more prone to fractures and breaks.

Medtronic also failed to take steps which could have prevented potential problems for thousands of individuals. They did not properly research or study their product and failed to take prompt actions after the difficulties were discovered. It took several months for Medtronic to halt sales and warn of this potential malfunction, even though they had received reports of lead fractures and the problems were publicly reported in a peer-review journal months before the defibrillator lead was officially recalled.

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