CHICAGO, May 1 (Reuters) – St Jude Medical Inc
published a report on its website on Tuesday that shows problems
with wires that carry electricity from implantable
defibrillators to the heart have persisted in the last 3 months.
St Jude’s Riata lead was recalled late last year after
reports the silicone coating around the wire lead eroded at a
higher-than-expected rate. The company halted sales of Riata in
late 2010.
What is more, the authors of the report, which updates the
performance of all of the company’s cardiac rhythm management
devices, acknowledged the failure rate is probably
underestimated since problems are only recorded when doctors
file complaints.
As of Feb. 29, 2012, the report said there were 671
confirmed cases of problems with Riata and Riata ST
defibrillator leads, which equates to a 0.30 percent incidence.
Of the 671 leads, 500 were not returned and 171 were returned
for analysis after a patient had them removed and replaced, or
when they were removed after death.
Just last month, St Jude halted sales of its QuickSite and
QuickFlex defibrillator leads due to concerns the insulation
could wear away and expose the wires.
Around the same time, HeartRhythm, a prominent medical
journal, published an article by Dr. Robert Hauser of the
Minneapolis Heart Institute that took a critical look at the
Riata lead line that was recalled in 2011. The article concluded
the St Jude product failed at a higher rate than Medtronic Inc’s
lead, prompting St Jude to ask for a retraction and
drawing even more attention to the issue.
The world’s second largest maker of implantable heart
devices, said the report, which can be found at
http://www.sjmprofessional.com
, supports the safety and reliability of
the current-generation Durata lead.
The company said it will enhance its registry and follow
patients who have the device indefinitely.
