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St. Jude Medical's reputation in the balance amid Riata, Durata scandals

Nov 27, 2012

What is the name of the medical device blacked out in a recent federal report made public by St. Jude Medical, one of the leading companies in the industry.

Speculation abounds, according to a New York Times report, on which product is redacted from a recent federal report on the medical device company. It could be one of its embattled implanted cardiac defibrillator lead wires, the Riata or the Durata, or it could be another device altogether. Whichever it is, the damage is already underway on the company's reputation and its value. 

In the last week, the company's stock price has dropped 12 percent, falling at the same as the company released information disclosed in a federal report last week. The report is a quarterly filing with the Securities and Exchange Commission and is viewed by shareholders who use these filings to ponder their future investment in a company. The report dealt mostly with a recent inspection of St. Jude's manufacturing facility. That report noted several deficiencies in the manufacture and record-keeping procedures. As St. Jude made the report public, it did so only after drawing a black line of the name of one of its devices specifically mentioned in the Food and Drug Administration report. 

Based on the company's recent history, it is likely one of its ICD lead wires. It has already recalled the Riata model from the market after it was shown to put recipients of these wires at significant risk of serious injuries or death if they failed. The Riata has a deficient insulated covering over the conductive ends of the lead wires that was prone to "inside-out" abrasions. This could cause serious internal injuries and it also could lead to an ICD not functioning properly, leading to serious heart damage or failure and death. Riata has been blamed for at least two dozen deaths and potentially thousands of serious injuries.

The redaction could also be on the Durata name. That is the new ICD lead the company released after the failing of Riata. It featured a new coating on the conductive ends that's not supposed to be prone to the same wear as the Riata. However, since its release, the company has faced increasing scrutiny over the safety of its new product.

Amid the height of scrutiny over Riata's safety, the company attempted to deflect blame rather than accept the faults of it but eventually vowed to work with the FDA and others in providing information on the best possible treatment for patients still relying on Riata. 

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