CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

January 16th, 2013

FDA Releases Warning Letter to St. Jude About ICD Leads

The FDA on Tuesday released the full text of a warning letter sent last week to St. Jude Medical. The company had previously disclosed the existence of the letter in an SEC filing but did not make clear the full extent of the FDA warning. The letter from the FDA is the latest in a series of setbacks and challenges to the company’s Durata and Riata ICD leads.

The letter makes clear that an FDA inspection last year of a California plant that manufactures the ICD leads turned up serious violations, and that the company’s response to those violations has not been adequate. In addition to numerous manufacturing, testing and documentation deficiencies, the letter states that the company failed to report within 30 days malfunctions relating to Durata leads that “would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.”

The FDA said it will no longer approve premarket approval applications of devices “reasonably related” to the violations until the violations have been corrected.

Click here for a PDF of the FDA warning letter.

Categories: Electrophysiology
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One Response to “FDA Releases Warning Letter to St. Jude About ICD Leads”

  1. Mark Dayer, MD PhD FRCP says:
    January 19, 2013 at 2:06 am

    I am somewhat surprised at this letter given the difficulties St Jude appear to be having (they are certainly haemorrhaging staff in the UK it seems) and the quality of the (few) people I have met and dealt with over the years (which seems to be high).

    Obviously this letter appears bad, but have the FDA inspected other manufacturers sites (is this sort of finding isolated or commonplace)?

    What does the statement “it will no longer approve premarket approval applications of devices “reasonably related” to the violations until the violations have been corrected” mean in practice, and have the shortcomings been addressed now?

    Thank you