Durata Lead Linked to a Defect

Questions have been raised about the safety of St. Jude’s Durata, a wire used to connect defibrillators to the heart, after a report to federal regulators claimed one of the devices failed when its wires frayed.

The Food and Drug Administration (FDA) received a report to its safety database from an unidentified doctor alleging wires inside the heart lead broke through the medical device and became externalized. The FDA has yet to confirm the credibility of the report, according to the Wall Street Journal.

This report is the first case of an externalized Durata lead.

In December 2010, St. Jude stopped selling an older version of the Durata called the Riata and recalled it in 2011 due to reports of high failure rates, according to Bloomberg. The new version uses a coating called Optium that was designed to stop the wires from fraying.

If you or a loved one has been harmed by an unsafe medical device, contact Sokolove Law for a free legal consultation. A product liability lawyer may be able to help you.

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