St. Jude Medical Inc. Message Board
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riata and durata failures
What failure modes is your facility seeing and how are they being detected?
Is your facility proactively screening patients for lead damage with flouro?
If a damaged lead is detected, is it being capped or explanted?-
We are seeing inside-out abrasion. It is a dangerous finding because many times the lead is electrically in tact so you would not find it unless you screened. It is unknown if the patent would actually be able to receive a shock should they need one. We are screening on battery changes as we do not have the man power to bring in all of our patients at this point. Would be great to get some guidance from STJ .....for the patients sake......
- 1 Reply to jim.metals
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If you have evidence, report it. Start a registry. Publish it. Send customer complaints, and contact the regulatory body for your country and complain to them if your not satisfied with the response. If you are actually work in a clinical capacity (you're probably not), you or your coworkers would actually be in a position to do something about it if it was a problem. If it is a problem and you're not doing anything about it - shame on you. If you don't have evidence, quit muckraking.
As you can read during the Q&A period for the conference call, Dan Starks denied that there was any problem with Durata due to its Optim coating. It would be unwise for a CEO to publicly say that and be wrong about it.
STJ published a report and said the reliability rating for Durata leads at one year is >99% out to two years. On page 139, STJ even spells out the total insulation breach failure rates. It's less than 0.1% for Durata (though it is >1% for model 1582 of the Riata leads - which STJ doesn't sell anymore).
The MAUDE database (where manufacturer's report their device problems to the FDA) has a bunch of reports with Riata and abrasion damage but relatively few of Durata or Riata ST Optim. Some Durata/Riata ST Optim are linked below.
Might this be a problem? Yes. There are some journal articles out there that indicate that inside-out abrasion is occurring with Riata - which STJ does not sell anymore. If you've got evidence that its a problem with Durata, report it. Or share it if your center has already report it.
Lead on Can Abrasion:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1954890
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1955135
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2015164
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2084281
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2084498
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2084194
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2084197
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2242740
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2242754
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2242441
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2242755
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2242920
Lead to lead
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2015091
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2084058
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2014710
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2015063
Inside-out abrasion (lead body disintegration)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2157205
STJ's product performance report
http://www.sjmprofessional.com/Resources/product-performance-reports/Product-Performance-Report.aspx
Dan Starks comments
http://seekingalpha.com/article/300584-st-jude-medical-s-ceo-discusses-q3-2011-results-earnings-call-transcript
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