Riata ST lead

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jafrica
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Riata ST lead

Post by jafrica » March 12th, 2016, 9:01 pm

Greetings...does anyone have any recent information on the St. Jude Riata lead problems? I was never told of any issues and have been caught completely off guard that I need a lead explant and new lead implanted next week due to suspected fracture/insulation issues. Very disappointed at lack of accountability and information from St. Jude. Any advice or contact information on this issue would be most appreciated. Thank you!
St. Jude's Epic II ICD. Viral cardiomyopathy, CHF

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freckles1880
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Re: Riata ST lead

Post by freckles1880 » March 13th, 2016, 7:58 am

First I did a search on this site and there are 131 references to the issues. Here is a link last updated January 2015 from the FDA FDA-Riata ST lead!
From what I read on here is don't be fooled by all the attorneys who want to file a lawsuit as it appears the payback is very little. Do check with your EP and the ICD rep to see what the company will cover. I also understand that in most cases they do NOT remove the old lead as it is more dangerous to do so.

I hope it all turns out alright for you.

wavhi
Bob

Medtronic-Visia AF implanted 7-8-2016 stayed with the with 6947 Sprint Quattro Secure lead. Original ICD implant 2-4-2009. ICD turned off 10-6-17 as stage 4 lung cancer taking over.
Major heart attack, carcinogenic shock and quad bypass 10-13-08 post myocardial infarction, old inferior MI complicated by shock and CHF, combined, Atherosclerosis, abdominal aortic Aneurysm, Seroma 7 cm, left leg. Stent in the left main vein 10-7-2014

My "Wardens" are my bride of 54+ years and my daughters.

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mykidsmom
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Re: Riata ST lead

Post by mykidsmom » March 13th, 2016, 11:29 am

I had a durata Lead and it fractured ...st jude said theyd never heard of these leads ever having a problem......so they wanted it back for investigation....thing was id had it implanted for a few years.....so getting it out wasnt going to be a walk in the park.....took 3 1/2 hrs i was awake for all the procedure, felt some slight pressure that was all...but it wasnt something id recommend to everyone...so here i am....3 years still and still asking my team for information and results of the "investigation" and i see ...durata have had many problems with this supposedly perfect lead.
I think.....Therefore I am.!!!!!

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mykidsmom
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Re: Riata ST lead

Post by mykidsmom » March 13th, 2016, 11:36 am

well interesting....The ST lead is now called the durata lead...and look at this....
Lead replacement and extraction
The FDA, St. Jude Medical, and the Heart Rhythm Society do not recommend routine removal of any leads due to the risks of explantation surgery.

Leads with normal imaging and normal electrical function
The FDA does not recommend routine replacement of leads with normal imaging and normal electrical function, although clinical management of patients should be individualized based on the patient's medical history and prognosis. Continue to monitor lead and device system performance.
Leads with abnormal imaging and normal electrical function
The FDA does not recommend routine replacement of leads with abnormal imaging and normal electrical function, although clinical management of patients should be individualized based on the patient's medical history and prognosis, as well as the severity of the visual abnormality. Continue to monitor lead and device system performance.
Leads with abnormal imaging and abnormal electrical function
Physicians should consider replacing the lead if there is evidence of insulation failure in imaging and if there is abnormal electrical function. If the lead is replaced, physicians should carefully weigh the risks and benefits of extracting the old lead compared to capping it and leaving it in place. The decision to remove a lead should be based on the individual patient as well as physician experience and the capabilities of the health care facility where the extraction would be performed. Lead extraction is a procedure that carries significant risk of severe injury and death, especially when the lead has been implanted for a long period of time.


I wish theyd told me this first...:(
I think.....Therefore I am.!!!!!

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jafrica
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Re: Riata ST lead

Post by jafrica » March 13th, 2016, 12:43 pm

My ICD internal alarm is going off frequently (sounding like a very loud British police car) due to electrical impedance problems. The settings were increased to try to stop the alarm from going off, but continued. Even when this was happening, no one told me of the lead issues! Mine has been implanted for 9 years. I am switching insurance and had visit with new EP who mentioned the problem and felt sure it was faulty and needed to come out asap as inappropriate shocks or failure to deliver appropriate therapy would result as lead continued to get worse. St. Jude rep. thought company MIGHT help with $1200 for out of pocket. Insulting! I miss 3 weeks of work, $2000 deductible and who knows how much else won't be covered. So frustrated! Were any of you with this lead told that it was faulty? On my bill, 9 years ago lead alone was $14,000. I have an issue handing this over to St. Jude for free when they were paid. When asked how long a lead should be expected to last, EP replied, "your whole life."

My kids mom....were you having any symptoms at all or told device was detecting lead issues? Did St. Jude take possession of your lead after extraction?

Were any of you with a St. Jude Riata or Riata ST notified by StJude, your EP or device clinic of potential problems?

Also, I will need new lead....anyone aware of any that should be avoided? Thanks so much..I feel pressed to be as informed as possible as my surgery date is coming soon.
St. Jude's Epic II ICD. Viral cardiomyopathy, CHF

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mykidsmom
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Re: Riata ST lead

Post by mykidsmom » March 13th, 2016, 1:09 pm

Im in canada here so i dont pay anything with our health insurance........no i had absolutely no symptoms indications, anything.....they found out via a regular icd check up at the clinic......but because im given to having SCAs they didnt want to even let me home that day.....Nope ive had absolutely no feedback at all from the company......and yes the company wanted their lead back which is why my ET wanted to pull it out rather than cap it...they figured capping it could leave me open to inappropriate shocks.....now my new lead is "rattly" but it can rattle away im not having it pulled out lol.. BUT i have to say..the surgery to get the lead out took 3 1/2 hrs for which i was awake....I didnt feel anything..except a bit of pressure now and then.....and when they replaced the lead..i got a whole new device too....so dont worry...you wont feel anything...and although they keep you in hospital overnight..your home the next day...

That sucks your having all these issues and costs.. where are you located? awful your insurance company wont cover everything..
I think.....Therefore I am.!!!!!

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jafrica
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Location: Iowa, US

Re: Riata ST lead

Post by jafrica » March 13th, 2016, 5:44 pm

Thank you for the reply and information. My device was just replaced with a Medtronic less than 2 years ago. I wish it had all been done at same time. I am sure I have a lot of scar tissue after 9 years so plan for general anesthesia. Did you get another St. Jude device and leads?
St. Jude's Epic II ICD. Viral cardiomyopathy, CHF

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mykidsmom
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Re: Riata ST lead

Post by mykidsmom » March 14th, 2016, 6:25 am

yes...because the clinic i go to for the ICD and my EP just use St Judes...i never had a choice...I didnt have a choice either on having general anesthesia or not either though.......but mind you ..i did contract an infection via the aftercare from that surgery and ended up having more surgery to remove tissue and check the leads and during that i insisted on being knocked out..
I think.....Therefore I am.!!!!!

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