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  #1  
Old 09-29-2011, 10:50 PM
Anonymous
 
Posts: n/a
Default Riata / Durata More Bad News!!!!

A friend just sent me an analyst report from Wells Fargo that exposes how bad Riata really is, and how St. Jude is vastly under estimating the failures and not providing proper recommendations (like looking for exposed conductors with fluoro) to physicians. A lot of information in it about many doctors not being confident with using 7 French leads.

It's pathetic that a Wall Street analyst knows more about this issue than St.Jude's physicians.

You guys are soooooooooo screwed!!!!!!!!!!!!!!!
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  #2  
Old 09-30-2011, 05:52 AM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Quote:
Originally Posted by Anonymous View Post
A friend just sent me an analyst report from Wells Fargo that exposes how bad Riata really is, and how St. Jude is vastly under estimating the failures and not providing proper recommendations (like looking for exposed conductors with fluoro) to physicians. A lot of information in it about many doctors not being confident with using 7 French leads.

It's pathetic that a Wall Street analyst knows more about this issue than St.Jude's physicians.

You guys are soooooooooo screwed!!!!!!!!!!!!!!!
Here's a little piece.. The time frame will be shorter though and Dr's will stop implanting Durata because its the same internal design

Here comes the BOOM........

Summary. Based on our physician checks, we expect the problems with the
STJ Riata ICD lead to become more visible within the medical community over
the next 6-9 months. In our view, the degree to which this impacts STJ’s ICD
business (33% of total STJ sales) will depend on (1) the scope of the problem; (2)
how well STJ handles the issue; (3) how STJ recommends managing active Riata
patients; (4) the competitor response; and (5) any actual or perceived spillover to
STJ’s newer Durata lead. At the very least, we think the increased prominence of
this issue will make it more difficult for STJ to gain share in the ICD market,
which is a key component of the bull case on this name. If STJ does not handle
this issue well, it could result in the company losing share to MDT and BSX. We
are lowering our valuation range to $36-38 from $49-50 to reflect the recent
softness in cardiology procedures, the strengthening of the dollar vs. the Euro,
and the Riata issues described in this note.
• We Expect The Noise Level Around Riata To Increase. Over the next 6-
9 months, we expect additional studies on the Riata malfunction rate to be
presented at medical meetings such as the American College of Cardiology (ACC)
in March 2012 and the Heart Rhythm Society (HRS) meeting in May 2012.
Physicians with whom we have spoken expect the failure rate in the recently
presented Irish study (15%) to be replicated based on the relatively high number
of Riata insulation defects seen in the FDA MAUDE database. At some point, we
would expect STJ to issue recommendations on how to screen and manage these
patients. If STJ recommends conducting a fluoroscopy on these patients every
3-6 months, we think a large number of patients with insulation defects will be
identified and the nuisance of screening such a large number of patients may
cause some backlash against STJ among implanters.
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  #3  
Old 09-30-2011, 09:04 AM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Stj it's D-day. You pathetic pieces told NO ONE about your issues and now it's coming from not only we competitive reps but Wall Street!!!!! Seriously???? WTF!!! You are done. Your POS company is too small to survive this storm. LMAO. No mercy.
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  #4  
Old 09-30-2011, 09:22 AM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

You're kidding, right? To small? Shut the fuck up. Even at worst cast scenario, the failure rate will be 1/2 of Fidelis and with BSX's 20 recalls, if you work for EITHER company, you are throwing the proverbial stone from the balcony of your glass house.

Just shut the fuck up and worry about whats going on at your company. Oh yeah, and PLEASE go out and tell your Docs about the issues so we can go in and remind them about how YOUR company fucked up their practice in the last 2 years!
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  #5  
Old 09-30-2011, 09:38 AM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

We still had a quattro lead the doctors trusted. Good luck selling a 7 FRENCH LEAD WITH THE SAME SHITTY DESIGN!!!!!!!!

The failure rates will be much higher that Fidelis, and you guys look like assholes when Wall Steet knows more about your problems then you do!
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  #6  
Old 09-30-2011, 10:28 AM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Hi. I'm an ICD rep for BSX/MDT (take your pick) and my volumes are down 10% this year, along with the rest of the market, so I"m spending all of my time on Cafepharma taking shots at STJ. Isn't this productive? I wonder why we keep laying people off?
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  #7  
Old 09-30-2011, 11:03 AM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Quote:
Originally Posted by Anonymous View Post
You're kidding, right? To small? Shut the fuck up. Even at worst cast scenario, the failure rate will be 1/2 of Fidelis and with BSX's 20 recalls, if you work for EITHER company, you are throwing the proverbial stone from the balcony of your glass house.

Just shut the fuck up and worry about whats going on at your company. Oh yeah, and PLEASE go out and tell your Docs about the issues so we can go in and remind them about how YOUR company fucked up their practice in the last 2 years!
You're missing the point. It's not about the # of Fidelis vs. Riata/Durata....it's about how STJ is handling it. There is an industry expectation after all the previous recalls that companies have learned how to report their failures. There is no tolerance amongst physicians and they can care less about the #'s and it's about the lack of ethics being exercised by STJ. STJ is too small to go 2 yrs without a defib lead and it will put you out of business if this goes to recalll status.. FYI -JEFFERIES just posted another analyst review on the RIATA Lead....wheels are coming off the sh** wagon boys!
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  #8  
Old 09-30-2011, 02:08 PM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Quote:
Originally Posted by Anonymous View Post
You're kidding, right? To small? Shut the fuck up. Even at worst cast scenario, the failure rate will be 1/2 of Fidelis and with BSX's 20 recalls, if you work for EITHER company, you are throwing the proverbial stone from the balcony of your glass house.

Just shut the fuck up and worry about whats going on at your company. Oh yeah, and PLEASE go out and tell your Docs about the issues so we can go in and remind them about how YOUR company fucked up their practice in the last 2 years!
Spoken like a rep from a SMALL failing company. ICD sales are 33% of your companies sales. That's scary. When Durata is pulled from the market what will you do? Your failure to report until 1000 failures and failure to deliver this info to your customers
Is going to do you in. you can't survive losing 33% of sales. This wouldn't have happened had you just been honest. You probably didn't tell your docs did you?
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  #9  
Old 09-30-2011, 03:19 PM
Anonymous
 
Posts: n/a
Smile Re: Riata / Durata More Bad News!!!!

I can't stop smiling!!!
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  #10  
Old 09-30-2011, 10:33 PM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

anyone have the note from Jeffries?
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  #11  
Old 09-30-2011, 11:03 PM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Quote:
Originally Posted by Anonymous View Post
You're missing the point. It's not about the # of Fidelis vs. Riata/Durata....it's about how STJ is handling it. There is an industry expectation after all the previous recalls that companies have learned how to report their failures. There is no tolerance amongst physicians and they can care less about the #'s and it's about the lack of ethics being exercised by STJ. STJ is too small to go 2 yrs without a defib lead and it will put you out of business if this goes to recalll status.. FYI -JEFFERIES just posted another analyst review on the RIATA Lead....wheels are coming off the sh** wagon boys!
We sell Brady leads to Boston basically under the same premise, no reason we can't ramp up Linox production too.
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  #12  
Old 10-01-2011, 12:57 AM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Quote:
Originally Posted by Anonymous View Post
anyone have the note from Jeffries?

Here you go.
St. Jude Medical (STJ)
How Do You Solve a Problem Like Riata?
Key Takeaway
Concern is growing over STJ's Riata Lead. The 7F ICD lead is no longer implanted
and the failure rate suggested by the company is quite low, but some clinicians
that are seeing increasing failures with the lead and are again questioning the
safety of smaller leads, with some reports of centers not implanting down-sized
leads at all. This is of particular issue for St. Jude, as they do not offer a larger
lead in their current portfolio.
Focus on Riata appears to be increasing on the heels of clinical papers and
physician awareness of potential issues. The recent abstract presented at European
Society of Cardiology in late August has gained traction, with some clinicians and investors
concerned about the potential for increasing failure rates with the St. Jude Riata lead model.
The issue is being worsened by the company denying any problem exists — all the way from
tech support to the investor relations department — which is creating a level of frustration
from those seeking additional information or guidance on how to address this issue. There
are reports that some centers have stopped implanting smaller sized leads, which essentially
blocks out St. Jude as they offer only 7F sized leads in their current portfolio.
On December 10, 2010, St. Jude issued a Dear Doctor letter to physicians indicating
the discontinuation of the silicone Riata lead and noted the worldwide failure rate due
to insulation breaches is 0.47% taking into consideration 227,000 silicone Riata leads
implanted. While the published failure rate remains quite small, some clinicians are now
indicating they believe the failure rate could be trending higher as the leads age and
physicians start to proactively inspect the leads via fluoroscopy, which should detect any
potential insulation breaches.
To be clear, the issues seen with the Riata lead to date appear to be more cosmetic, with lead
insulation breaches, rather than catastrophic failure of the lead. However the lack of clarity
on how to manage this issue is creating concern among the clinical community.
Valuation/Risks
We use 12x our 2012 EPS to arrive at a one-year price of $44 (from $55). The 12x multiple is in
line with current levels and reflects the uncertainty growing in the company's ICD franchise.
Other risks include slower CRM share gains, slowing in overseas growth, and regulatory risk
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  #13  
Old 10-01-2011, 01:16 AM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Quote:
Originally Posted by Anonymous View Post
You're kidding, right? To small? Shut the fuck up. Even at worst cast scenario, the failure rate will be 1/2 of Fidelis and with BSX's 20 recalls, if you work for EITHER company, you are throwing the proverbial stone from the balcony of your glass house.

Just shut the fuck up and worry about whats going on at your company. Oh yeah, and PLEASE go out and tell your Docs about the issues so we can go in and remind them about how YOUR company fucked up their practice in the last 2 years!
Durata anyone????? Look this up on MAUDE......a picture paints what a thousand words can not.

St. Jude Durata 7120 (24.5 months of implant)


EdgeofOptimSplitTearofOptimSiliconeRupture
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  #14  
Old 10-01-2011, 07:53 AM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Do you have a link?
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  #15  
Old 10-01-2011, 12:35 PM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Quote:
Originally Posted by Anonymous View Post
Do you have a link?
Just google Jefferies Riata report on 9/30/2011
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  #16  
Old 10-02-2011, 01:22 AM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Quote:
Originally Posted by Anonymous View Post
Do you have a link?
Insulation Defects of Thin High-Voltage ICD Leads: An Underestimated Problem?
September 20, 2011 0 Comments
Insulation Defects of Thin High-Voltage ICD Leads. Background: Long-term lead failure is a known complication of ICD therapy. The precise incidence and sequelae of insulation defects at the tricuspid level, however, are not well characterized.
Objective: This study determined the risk of lead failure, with particular emphasis on insulation defects at the level of the tricuspid valve, in a large series of consecutive ICD recipients.
Methods: Data from 357 consecutive patients, who had received transvenous 7 and 8 French ICD-leads (St. Jude Medical, Riata family) and were followed at our center, formed the basis of this study.
Results: During a mean follow-up of 42 ± 24 months, 30 of 357 (8%) patients required surgical intervention due to lead failure. For overall lead defects, lead access via the subclavian vein and subpectoral device placement were independent predictors of overall lead failure (OR 3.47, 95% CI 1.38–8.72, P = 0.013 and OR 3.83, 95% CI 1.77–8.27, P = 0.001, respectively). Lead insulation defects at the level of the tricuspid valve accounted for 20% of all lead failures. Diagnosis of this specific insulation defect could only be established by fluoroscopy, while electrical parameters were within normal limits in all of these patients. On univariate but not on multivariate analysis the presence of nonischemic cardiomyopathy was a predictor of this lead complication (OR 8.2, CI 1.5–46.1, P = 0.02).
Conclusion: Insulation defects of 7 and 8 French ICD leads at the tricuspid level represent an important complication of device therapy. Even moderate changes in lead impedance within the normal limits at follow-up should prompt careful fluoroscopic evaluation to avoid spurious shocks.
(J Cardiovasc Electrophysiol, Vol. 22, pp. 1018-1022, September 2011)
DAMIR ERKAPIC M.D.1, GABOR Z. DURAY M.D.1, TAMAS BAUERNFEIND M.D.1, SALVATORE DE ROSA M.D.2, STEFAN H. HOHNLOSER M.D., F.H.R.S.1
Article first published online: 1 APR 2011
DOI: 10.1111/j.1540-8167.2011.02055.x
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  #17  
Old 10-02-2011, 01:43 AM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Lets just say all of upper mgmt on the West coast was well aware of problems with Durata and later Riata....from the Bay area to Sacramento, etc....it is real, whether SJM sweeps it under the rug for their stock price...here's the deal does this company give a damn about patients???? I say not...but it's all about the stock price!!
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  #18  
Old 11-29-2011, 11:35 PM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Do any of you care about those of us who have these devices? Or just about your income?
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  #19  
Old 11-30-2011, 08:03 PM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Quote:
Originally Posted by Anonymous View Post
Do any of you care about those of us who have these devices? Or just about your income?
I care. My thoughts to you as a patient is, I'm sorry you had to find out like this. I do regret that you are reading these horrific posts and think this could pertain to your risk of death. The truth is, if you have this lead, you are already deemed a high risk for sudden cardiac death or deadly arrhythmia (the whole reason you have the defib). If you are concerned, I mean really concerned, ask your doctor to look at it. Be adiment. It's your body, your life. You have the right to be proactive and take control of your situation. If he / she refuses, seek help elsewhere.

I wish you the best.

not a STJ employee
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  #20  
Old 11-30-2011, 09:03 PM
Anonymous
 
Posts: n/a
Notworthy Re: Riata / Durata More Bad News!!!!

I am a patient too. And I LOVE reading the posts here. They are an honest and sobering window into the hearts and minds of CRDM industry. Your callousness and disregard for your own cohorts never ceases to amaze me.

Now in words you can understand: You are a bunch of pathetic trolls.
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  #21  
Old 11-30-2011, 11:22 PM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Quote:
Originally Posted by Anonymous View Post
I am a patient too. And I LOVE reading the posts here. They are an honest and sobering window into the hearts and minds of CRDM industry. Your callousness and disregard for your own cohorts never ceases to amaze me.

Now in words you can understand: You are a bunch of pathetic trolls.
This is no different than any other industry where folks joust....my concern is if this is the only "take away" you get out of this thread is that we fight, then you're missing the point. The common message is to pressure each other to report the truth and name calling is just attention getter's.

This is a simple stress reliever for a bunch of people who think their stuff is superior than the other but at the end of the day we are commited and driven to improve the QOL of our patients.....aside from our barbs, we all agree with the right thing.....patients first!!!
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  #22  
Old 12-01-2011, 12:42 PM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Of course I get a lot more out of this board than just the barbs you throw at each other. This is where I learned about those BSC headers that break off the can (which is clearly too thin to properly support a tall CRT header). Or how the Riata's core cuts through its insulation from inside out (and how the Durata Optim insulation is not that much better). Or about that Biotronik Lumax that exploded inside a patients' chest (and the story was quickly and suspiciously pulled from Europace.)

Those are valuable bits of information my doc would never think to mention. And for that, I thank YOU!
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  #23  
Old 12-01-2011, 12:44 PM
Anonymous
 
Posts: n/a
Arms Re: Riata / Durata More Bad News!!!!

Oh... PS: You're still a bunch of trolls.
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  #24  
Old 12-01-2011, 01:14 PM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Quote:
Originally Posted by Anonymous View Post
I am a patient too. And I LOVE reading the posts here. They are an honest and sobering window into the hearts and minds of CRDM industry. Your callousness and disregard for your own cohorts never ceases to amaze me.

Now in words you can understand: You are a bunch of pathetic trolls.
So true, but you should understand that 99.9% of these trolls are sales reps. They are for the most part overpaid, amoral, greedy m*f*ckrs.
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  #25  
Old 12-01-2011, 01:18 PM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Quote:
Originally Posted by Anonymous View Post
So true, but you should understand that 99.9% of these trolls are sales reps. They are for the most part overpaid, amoral, greedy m*f*ckrs.
U know nothing about me. And who are u to say that? I hate stj but not all of their reps are bad people.
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  #26  
Old 12-01-2011, 05:06 PM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

[quote=Anonymous;4161278]Of course I get a lot more out of this board than just the barbs you throw at each other. This is where I learned about those BSC headers that break off the can (which is clearly too thin to properly support a tall CRT header). Or how the Riata's core cuts through its insulation from inside out (and how the Durata Optim insulation is not that much better). Or about that Biotronik Lumax that exploded inside a patients' chest (and the story was quickly and suspiciously pulled from Europace.)



Maybe you need to read up on the Medtronic Marquis and Sprint Fidelis recalls if you are keeping a list.
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  #27  
Old 12-01-2011, 10:13 PM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Quote:
Originally Posted by Anonymous View Post
Of course I get a lot more out of this board than just the barbs you throw at each other. This is where I learned about those BSC headers that break off the can (which is clearly too thin to properly support a tall CRT header). Or how the Riata's core cuts through its insulation from inside out (and how the Durata Optim insulation is not that much better). Or about that Biotronik Lumax that exploded inside a patients' chest (and the story was quickly and suspiciously pulled from Europace.)

Those are valuable bits of information my doc would never think to mention. And for that, I thank YOU!
So headers never broke off cans. 4 headers were found loosened sub pectorally. Which division of mdt to u work for?
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  #28  
Old 12-02-2011, 03:47 AM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Seems to me like SJM is biting off a bit more than they can chew...why is there such ridiculous focus on moving technology forward, when they technology you "already perfected" was never fully certified safe? Dont bother starting a response by saying that the devices WERE certified safe...because we all know the FDA's BS programs (510K and other sleazy-fast review/approval processes) and device companies' "in-house reviews" are all seriously flawed.

I will stand up in support of a patient who asks an HONEST question like: "Do any of you care about us who have these devices?" Why??? Because I HAVE your devices. Don't grab your balls and tell someone you "feel for them" and you are sorry, but since they are AT RISK FOR CARDIAC FAILURE anyway (since they have one of the leads in question), they should consult their doctor. Isn't that the most common cop out SJM throws out at patients?? You should contact your doctor if your having problems...oh, contact your doctor if you are noticing changes that are uncomfortable...make sure you tell your doctor...blah blah blah.

If you truly valued patients, you would REPORT adverse events to the FDA. Thats your damn job as a patient rep...and guess what?? If you dont report the event and the FDA finds out that you didn't, the hammer can come down pretty hard. Go ahead, tell me I have no clue what I am talking about. Its not like I volunteered 3 years to SJM NMD to help promote, market, do media pieces, and become a patient ambassador. HEY, I know the damn policies that the FDA handed out to you in the past 3 years regarding adverse event reporting...and trust me, if the world knew what you WERENT reporting, all I can say is WOW. The FDA claims they can stop your manufacturing operations based on violation of this reporting process, but we all know the FDA is in the pockets of the GOP, who are in the pockets of SJM, who are in the pockets of one another...you are all playing pocket pool just pleasuring each other...not giving a @%## about the patients you are slowly disabling or killing because you cant MAN UP and report the problems, knowing that a recall would be imminent.

I used to be a St Jude Med "success story," I was featured on your website for years...but God forbid that I experience some problems with one of my two SJM implants, right? I didn't know that changed the fact that I was a success story! This company never fails to amaze me...I gave you my TRUST, my BODY, and FULL DISCLOSURE...you gave me SHADY BUSINESS and SECRETIVE recalls/Field Actions, an OCCASIONAL moment of your time (literal moment), and disclosure?? HA!! What a joke. Im blacklisted with SJM NMD...its probably a good thing b/c if the world knew what I DO, if the world knew what SJM did to me, your little Riata problem would be the LEAST of your worries. A 33% compromise of business? Try 100%.
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  #29  
Old 12-02-2011, 02:50 PM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Quit stewing! You either have a case to sue SJM, or you don't. That is your avenue for recourse.
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  #30  
Old 12-02-2011, 05:41 PM
Anonymous
 
Posts: n/a
Default Re: Riata / Durata More Bad News!!!!

Quote:
Originally Posted by Anonymous View Post
Seems to me like SJM is biting off a bit more than they can chew...why is there such ridiculous focus on moving technology forward, when they technology you "already perfected" was never fully certified safe? Dont bother starting a response by saying that the devices WERE certified safe...because we all know the FDA's BS programs (510K and other sleazy-fast review/approval processes) and device companies' "in-house reviews" are all seriously flawed.

I will stand up in support of a patient who asks an HONEST question like: "Do any of you care about us who have these devices?" Why??? Because I HAVE your devices. Don't grab your balls and tell someone you "feel for them" and you are sorry, but since they are AT RISK FOR CARDIAC FAILURE anyway (since they have one of the leads in question), they should consult their doctor. Isn't that the most common cop out SJM throws out at patients?? You should contact your doctor if your having problems...oh, contact your doctor if you are noticing changes that are uncomfortable...make sure you tell your doctor...blah blah blah.

If you truly valued patients, you would REPORT adverse events to the FDA. Thats your damn job as a patient rep...and guess what?? If you dont report the event and the FDA finds out that you didn't, the hammer can come down pretty hard. Go ahead, tell me I have no clue what I am talking about. Its not like I volunteered 3 years to SJM NMD to help promote, market, do media pieces, and become a patient ambassador. HEY, I know the damn policies that the FDA handed out to you in the past 3 years regarding adverse event reporting...and trust me, if the world knew what you WERENT reporting, all I can say is WOW. The FDA claims they can stop your manufacturing operations based on violation of this reporting process, but we all know the FDA is in the pockets of the GOP, who are in the pockets of SJM, who are in the pockets of one another...you are all playing pocket pool just pleasuring each other...not giving a @%## about the patients you are slowly disabling or killing because you cant MAN UP and report the problems, knowing that a recall would be imminent.

I used to be a St Jude Med "success story," I was featured on your website for years...but God forbid that I experience some problems with one of my two SJM implants, right? I didn't know that changed the fact that I was a success story! This company never fails to amaze me...I gave you my TRUST, my BODY, and FULL DISCLOSURE...you gave me SHADY BUSINESS and SECRETIVE recalls/Field Actions, an OCCASIONAL moment of your time (literal moment), and disclosure?? HA!! What a joke. Im blacklisted with SJM NMD...its probably a good thing b/c if the world knew what I DO, if the world knew what SJM did to me, your little Riata problem would be the LEAST of your worries. A 33% compromise of business? Try 100%.
Just so you know, I posted the comment to you....first I don't have ball to grab....second, I do feel for you as a patient. I am a patient too. So, do not underestimate the people posting here. We are in the same boat. I have a defib. I am at risk for sudden cardiac death. I have a Riata. I'm a physician........on and on and on. So, the post wasn't to anger you but to embrace you and encourage you.
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