Over 2,000 Youths at Greater Risk with Recalled Medtronic Leads

posted on:
October 25, 2007

author:
Staff

Medtronic's recall of its Sprint Fidelis defibrillator lead potentially affects 235,000 people. According to reports, approximately 2,000 of them are under the age of 21 and may be at greater risk than adults implanted with the same product. 

Why younger patients are at greater risk

According to a report in the Wall Street Journal, the leads that attach a defibrillator device (used to shock the heart into a normal rhythm) tend to "come under greater stress in more active people, including kids, adolescents and younger adults."

The recall has placed a great emphasis on the fact that some of the Fidelis leads can fracture and cause the defibrillator to shock the heart unnecessarily (some patients have reported being shocked dozens of times without cause) or to fail in shocking the heart when needed.

According to data released by the company, the Sprint Fidelis failure rate was higher, 3.8%, in patients under the age of 21 than for the entire population, which had a failure rate of 2.3%. Younger adults and children are also at a greater risk because their heart beats faster and may place more stress on the leads that are attached to their hearts.

What Medtronic is doing

Medtronic has said that it will pay to replace any defective leads. Patients should see their doctors immediately to see if they have a lead that might be defective. The defective leads have the following identification numbers: 6930, 6931, 6948 and 6949.

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