Posted on 05/22/2019 11:01:42 AM PDT by GailA
Shortly after the recall, the FDA and Medtronic made a deal to keep reports about the widely used device’s malfunction incidents — now totaling 50,000 — shielded from public scrutiny.
The FDA has allowed device makers to file 1.1 million reports of injuries or malfunctions to a little-known internal FDA database since 2016, a recent Kaiser Health News investigation has found, spurring top FDA officials to pledge to open those records within weeks and shut down the “alternative summary reporting” program.
For the past two decades, the agency has granted various devices different types of so-called exemptions from reporting to their public-facing database, called MAUDE, KHN has found.
(Excerpt) Read more at khn.org ...
They have the same mindset as the top Boeing execs with their super Max bs.
Government conspiring with industry to keep the public in the dark. Ain’t Fascism grand?
The FDA deserves the Boeing Award for murdering
innocents by covering up INEFFECTIVE ENGINEERING.
Names? Indictments?
Is this not worse than the school payoffs?
Slew of reports showed up this morning.
http://m.startribune.com/fda-hidden-database-included-37-000-reports-of-problems-with-medtronic-defibrillator-wires/510238032/?
fbclid=IwAR0ygkuOXgmL2LMUGXGHurONhCzedpOnN8pUojA6HUXCr2WiTMRPqdX9wfg
Imagine if Bernie were in charge.
The government would own the manufacturer and you.
Much worse as it’s much deeper. FDA has been doing this for 2 Decades.
If you have Netflix you can stream THE BLEEDING EDGE tells you how all these crap devices get FDA OK’s. All they have to do is make a minor design change and they get approved without proving they are better or similar. From Hip Replacements to any device used in your body.
Medtronics has been on my radar for a decade when the Bladder one was suggested for a condition I DIDN’T have, it does not have a good track record. Battery changes require another surgery, the pacemaker is NOT anchored in the body, and can float or drop elsewhere. The Spinal one the Probe that goes into the Spine can grow Adhesion’s on them and Can’t be removed thus making your spine pain permanently worse, if you happen to be one of the unlucky people it happens to. I don’t think a 50% Failure rate which was the score at the time is was suggested warrants a FDA approval, that was for the Bladder Pacemaker.
Have they made design changes who knows considering all the Lies that the FDA has hid. Ditto goes for Medications. Look at the China Made Hypertension BP Cancer causing drugs they’ve had to recall.
BUMP!
Omniscience heart valve. Working 29 years and counting. Tick, tick, tick.
Yikes! I worked for them for a year back in 2006 at their corporate HQ.
The building was swanky and they were swimming in cash. The margins in the medical device industry are fat.......75% gross and 25% net. It was like night and day coming from working at Wally’s corporate HQ for years.
Short Medtronics.
Two decades? Who was running things then?
Nothing good comes of the situation when the line between regulator and regulated become blurred.
Who else who ever the past few presidents appointed to over see the FDA, Lobbyist, and Pharma.
FDA approved on short trial Orrisa for Endometriosis pain Ads are running daily on TV. Crap came out with a Black Box Warning of Bone Density Issues, which means these Young things in their 20’s possible a littler older will have some stage of Osteoporosis by 35. And who knows what else will happen when you screw up a Woman’s Hormones! Heart Disease is quite possible, Caner too. I’ve had to many run in’s with these Black Box drugs not to be leery of them. I avoid them like the Plague. Same with off label use.
They are also pushing the Generic Neurotin, and Lyrica for Pain control both are Very High Side effect and Must be “weaned” off them. They don’t tell you that they can cause Hair, Libido loss, or A Fib, depression, Suicide thoughts. They sure don’t work on pain, might relieve some Neuropathy symptoms but there are safer meds to do that. https://www.rxlist.com/neurontin-side-effects-drug-center.htm
PING
*** Government conspiring with industry to keep the public in the dark. Ain’t Fascism grand? ***
So we are really a Corporatocracy? I always rejected that claim, but lately....
The government would own the manufacturer and you.”
And can’t sue the government for compensation.
And, the motivation for developing such technology goes right in the toilet too.
Capitalism is much better than Socialism bit it work best in a moral society.
Too many are falling for a satanic lure of lies rather than Judeo Christian ability to really see what is good and evil.
God let’s us see and choose.
Just had my pacer checked earlier today. A Boston Scientific.
Battery good for another 13 yrs.
I’m glad my pacemaker is made by Boston Scientific.
SHUDDER, Biden did enough damage. It’s not been posted, showed up in this morning Email that I have flagged for Opioid, Illicit drugs in my news feed. HE MADE THE FAKE CRISIS WORSE.
This is the SHRINK who LIED. Andrew Kolodny GRAPHS included https://www.acsh.org/news/2019/05/22/opioid-cutoff-article-tells-us-how-badly-pain-patients-were-harmed-too-bad-kolodny-was-included-14043
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