Durata Lead Problems Prompt FDA Warning Letter

October 11, 2013

Important Information

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At A Glance

This Alert Affects
Patients who have been implanted with a defibrillator containing a lead, or electrical wire, known as Durata. This product is manufactured by St. Jude medical.
Damages
Patients who were injured by the Durata defibrillator lead may be entitled to compensation for medical bills and other damages.
Company(ies)
St. Jude Medical
Additional Details
The Durata lead is an electical wire which connects a defibrillator to the patient's heart.
Date
In Oct. 2012, the FDA conducted an inspection of a St. Jude manufacturing plant in California, finding 11 problems related to the design and manufacture of the Durata defibrillator lead.