Comments on: St Jude’s faulty Riata leads cause 22 deaths. The reason will surprise you.

By: Eric

Eric — Mon, 18 Jun 2012 21:07:41 +0000

I have leads outside the insulation but there does not seem to be a path forward to resolve the issue. The leads have separated quite a distance from the sheath. I know if I was dealing with anything else I would replace the leads but the real issue is with the barb that attached the lead to the heart.

By: Mary Greenlees

Mary Greenlees — Sat, 02 Jun 2012 15:20:40 +0000

My son has this lead for the past 6 years.
He is 24 years old, tall and very active.
It appears that he may need to have this lead
removed and replaced.

Can you tell me what Dr and medical center in the nation has removed the most riata leads?

By: Anonymous

Anonymous — Tue, 27 Mar 2012 11:09:43 +0000

6 DURATA paltient deaths in MAUDE

From MAUDE database, searching Durata. 2054911 – pt death, no HV therapy 2069033 – pt death, no episodes? 2176257 – pt death following inappropriate shocks 2088952 – pt death, no shock and two possible “externalized conductors”: 2157205 and 2156832 and even though the new designs are “perf-less” there were two deaths that may or may not have been attributed to perf: 2015172 and 2084488 the .

By: Anonomous

Anonomous — Mon, 26 Mar 2012 19:24:43 +0000

There is a big potential here for biased authors on the study. Medtronic is based out of Minneapolis too. The Durata lead family is the most researched HV lead in history with 6 years of data and 278000 implants. There have not been any major issues with Durata or even Riata with optim coating. Most of the issues reported are for a very small area of leads which is the uncommon single coil riata silicone. There is clearly an increased risk with this one type of hv lead. FDA did not recommend extraction like they did with Medtronic Fidelis which had issues with welds and connections within lead. It is a recall and the advice is to closely monitor these patients without exposing them to more risks by doing xrays, or worse surgery to extract.