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Medtronic removes defibrillator leads from market

Device Regulation Alert: Safety, Compliance and Reimbursement News, November 5, 2007

The FDA issued a statement on October 15, 2007, recognizing Medtronic's decision to voluntarily take its Sprint Fidelis defibrillation leads out of the market. The leads had fractured "in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all," according to the FDA statement.

The statement noted the fractures had been linked to reported adverse events including some deaths and complications. A Medtronic press release explained voluntarily suspending distribution of the leads has no impact on Medtronic pacemaker patients.

In its statement, the FDA says just because the leads are "more prone to fracture" doesn't mean that every lead will break. Although the leads will no longer be manufactured, marketed, or sold, both the FDA and Medtronic recommend against surgically removing the leads from patients in whom they've already been implanted. Instead the FDA agreed with Medtronic's recommendation that patients see their physician if they have a Fidelis defibrillator lead and defibrillator settings can be adjusted to help detect a fracture.

According to Medtronic's release, its Physician Quality Panel and the Heart Rhythm Society recommend against removal of the leads because the risks of removal outweigh the "small risk to patients of a lead fracture." A fracture may result in "audible alerts, inappropriate shocks and/or loss of output."

The company provides information for patients and their physicians on the Medtronic Web site. Among the company's recommendations are device programming that sets the device to monitor for potential problems. Medtronic indicated it also will contact affected patients directly, advising them to talk to their physicians. Medtronic has also established a Web site and toll free number for more information.

Click here to read the FDA's statement. Click here to read Medtronic's press release, which includes a link to its web site dedicated to the Fidelis leads.

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