Riata Recall

Hi All. I am new to this group and glad I found it.  I had a St Jude ICD implanted in 2004 with one of my leads being a Riata. Since I got this in 2004 I was shocked once in 2007 for no reason. They replaced the ICD with a Medtronic and I still have the St Jude leads.

Since 2004 I’ve gone to all my visits for my ICD check and it is still over sensing.  I know they have a recall on one of my leads.  I had a chest xray done and I am really nervous about all of this as to what they do now.  My cardiologist didn’t even know about the recall until I called her.

Any advice on what I should do would be greatly appreciated.

Thanks, Susan

6 Comments

Recall

by Brenda Price - 2011-12-30 05:12:08

My ep told me at my last check-up in November that the St. Jude lead had some problems. The insulation has some abrasion issues and basically looks worn out and since then I have seen the recall but unable to see what percentage they are talking about.
I will have a new device probably in the early spring and prior to that a scan to check lead.I already have a defective lead that is capped so I have no more room and am 100% paced.
Will let you know any information I receive

Recall

by cbaker - 2012-01-01 11:01:31

This is from the FDA recall letter of early December: "The affected model numbers are the Riata (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042). The FDA has classified this recall as a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction. As communicated in the Physician Advisory Letter, the clinical implications of externalized conductors in a defibrillation lead without electrical anomalies are not fully known or understood at this time. Externalized conductors can present as only a visual observation on x-ray or fluoroscopy without any associated clinical or device-related observations. If the electrical integrity of a lead were to be compromised, failure to deliver appropriate therapy, or the delivery of inappropriate therapy, could potentially occur, and could lead to a serious adverse event or death."

Some of these don't show an obvious problem uless they fluoro-ed (x-rayed by a fluoroscope). That's how they see the abrasion (that leads have worn through the outer casing). Susan, I'd ask what the results of the xray were speficially (any sign of abrasion?) and ask what their monitoring plan is. Heck, with your history, I'd think they'd make sure you're being checked often and accurately. Good luck!


recall

by suestapleford - 2012-01-04 07:01:58

I talked to my doctor and she said there is know way on the xray that it can show abrasions only if it was broke in half she called st jude and they said i have nothing to worry about. she also said that she is just going to keep and eye on me when i go there for machine check i do not believe any of this one of the side effects and recall is oversensing to me this is not right and i think they are trying to cover there selves which i think is wrong any suggestions.st jude never even notified my doctor.


Thanks
Susan

Re Recall

by Brenda Price - 2012-01-29 06:01:50

My ep said they would be able to see any abrasion in the lead and decide from there what if any action was needed by a heart scan.
This will be done prior to pacer and icd battery change with my full awareness and input. Stay on top.

Nothing to worry about is from someone that does not have to depend on the lead

Riata Recall

by suestapleford - 2012-02-19 10:02:19

OK so i went to another doctor he says there is nothing wrong with lead.but wants to put in another icd.i said no.went back to my cardiologist she agrees with the other doctor .but my ep says there is something wrong with my lead.they havent even done the fluroscopic test on me .i can see my ep seeing if something is wrong cause she checks my icd every 3 months. going to see my ep that would make the decision.

recall

by suestapleford - 2012-07-01 02:07:02

Ok so i had the fluro done because i was so persistant and it does show abrasion going to talk to doctor on july 12th about what to do i am really scared .

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