Study: St. Jude Defibrillator Failures Persist
Prominent Cardiologist Reports Defibrillator Defects
Robert Hauser of Minneapolis Heart Institute found that St. Jude's “Riata ST Optim™” and its newer “Durata ICD” leads had sometimes failed due to insulation problems. Leads are the ends of electrical wires that transmit an electric shock from the defibrillator to the person. The medical device is supposed to deliver a life-saving shock if it detects a dangerous cardiac rhythm.
“The results of this study suggest that Optim … does not prevent critical insulation failures in Riata ST Optim and Durata leads that are caused by friction with the can or another device,” Robert Hauser.
St. Jude responded that it is still reviewing the information, but to date the data supports the safety and reliability of its Durata leads.
Findings from Study
- Returned leads for clinical events that occurred between December 2007 and January 2012:
- 15 reports for Riata ST Optim
- 37 reports for Durata leads
- 8 of 15 Optim leads had can abrasions and three abrasions were caused by friction with another device (most likely another lead).
- 4 of these abrasions resulted in high-voltage failures and one death.
- 1 failure was caused by an internal insulation defect.
- 12 Durata leads had can abrasions, and 6 leads had abrasions caused by friction with another device.
- Out of these 18 can and other device abrasions, 13 (72%) had electrical abnormalities.
The study concluded that the Optim and Durata leads failed because of insulation abrasions. Optim did not prevent these abrasions, which occurred less than 4 years after implant. However, the study also indicated that further studies are needed to determine the clinical implications.
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