Comments on: Has FDA ‘Dumbed-Down’ MAUDE Accident Database? http://mrimetaldetector.com/blog/2009/09/has-fda-dumbed-down-maude-accident-database/ Info on ferromagnetic detection and MRI safety & screening Sat, 04 Feb 2012 18:25:20 +0000 hourly 1 http://wordpress.org/?v=3.3.1 By: Nancy E. Bowling http://mrimetaldetector.com/blog/2009/09/has-fda-dumbed-down-maude-accident-database/comment-page-1/#comment-44093 Nancy E. Bowling Fri, 22 Apr 2011 13:16:44 +0000 http://mrimetaldetector.com/blog/?p=583#comment-44093 I was just reading on ClinicalTrials.gov, where they keep information on clinical trials, and I looked up Cyberonics' depression studies and there were quite a few, but NCT00305565 says 330 people were enrolled and NCT00533832, which was the Pivotal Trial [D02] of VNS for TRD had an enrollment of 266. Right there is almost 600 people, so why couldn't this company come up with the 460 people required in their 'Conditions of Approval' studies? Then at: http://dynamic.cyberonics.com/depression/hcp/AboutVNSandTRD/clinicalstudy.aspx it is discussing the Pivotal study acute phase-12 wk double blind, randomized study. It says 'all of the 235 patients were implanted' for this depression study, and then goes on to say the ages were 18-80. 80 years old? Are they serious? My sister had this surgery and she was in good health and half that age, and it almost killed her. Why in heavens name would they implant an 80-year old? Was this person even in full control of his mental facillities? I was just reading on ClinicalTrials.gov, where they keep information on clinical trials, and I looked up Cyberonics’ depression studies and there were quite a few, but NCT00305565 says 330 people were enrolled and NCT00533832, which was the Pivotal Trial [D02] of VNS for TRD had an enrollment of 266. Right there is almost 600 people, so why couldn’t this company come up with the 460 people required in their ‘Conditions of Approval’ studies? Then at: http://dynamic.cyberonics.com/depression/hcp/AboutVNSandTRD/clinicalstudy.aspx it is discussing the Pivotal study acute phase-12 wk double blind, randomized study. It says ‘all of the 235 patients were implanted’ for this depression study, and then goes on to say the ages were 18-80. 80 years old? Are they serious? My sister had this surgery and she was in good health and half that age, and it almost killed her. Why in heavens name would they implant an 80-year old? Was this person even in full control of his mental facillities?

]]> By: Tobias Gilk http://mrimetaldetector.com/blog/2009/09/has-fda-dumbed-down-maude-accident-database/comment-page-1/#comment-22715 Tobias Gilk Tue, 28 Dec 2010 17:07:03 +0000 http://mrimetaldetector.com/blog/?p=583#comment-22715 MAUDE is a mess. Yes, some events appear in MAUDE a L-O-N-G time after they're reported. Generally speaking, I allow 6 months to elapse before I try and perform any year-over-year comparisons of reports. This means that I won't start to aggregate the 2010 data on MRI accidents until we're half way through 2011! The FDA works on its own clock. I've got a FOI request that just passed it's 1-year anniversary! Tobias MAUDE is a mess. Yes, some events appear in MAUDE a L-O-N-G time after they’re reported. Generally speaking, I allow 6 months to elapse before I try and perform any year-over-year comparisons of reports. This means that I won’t start to aggregate the 2010 data on MRI accidents until we’re half way through 2011!

The FDA works on its own clock. I’ve got a FOI request that just passed it’s 1-year anniversary!

Tobias

]]> By: Brian Todt http://mrimetaldetector.com/blog/2009/09/has-fda-dumbed-down-maude-accident-database/comment-page-1/#comment-20908 Brian Todt Wed, 15 Dec 2010 21:19:25 +0000 http://mrimetaldetector.com/blog/?p=583#comment-20908 The FDA MAUDE database online search is lagging many months behind in publishing reports. An example is the following 6mo old report: Report Number: MW5016338 Date of Event: 6/5/2010 Mfr: SIEMENS MEDICAL FOIText: RESEARCHERS CONDUCTING CARDIAC IMAGING ON SWINE MODEL, INADVERTENTLY WHEELED A TRANSPORT CART INTO A 1.5T MRI SCANNER. A FERROUS IV PUMP ON THE CART BECAME A PROJECTILE AND WAS PULLED TO THE MAGNET HOUSING. AN ATTENDANT'S HAND WAS PINCHED BADLY WHEN TRYING TO REMOVE THE PUMP. NO BROKEN BONES. MAGNET HOUSING REQUIRED REPLACEMENT. TWO MINUTES PRIOR TO THE INCIDENT, ALL PRESENT WERE INSTRUCTED NOT TO ALLOW SAID PUMP INTO THE SCAN ROOM. The FDA MAUDE database online search is lagging many months behind in publishing reports. An example is the following 6mo old report:

Report Number: MW5016338
Date of Event: 6/5/2010
Mfr: SIEMENS MEDICAL
FOIText: RESEARCHERS CONDUCTING CARDIAC IMAGING ON SWINE MODEL, INADVERTENTLY WHEELED A TRANSPORT CART INTO A 1.5T MRI SCANNER. A FERROUS IV PUMP ON THE CART BECAME A PROJECTILE AND WAS PULLED TO THE MAGNET HOUSING. AN ATTENDANT’S HAND WAS PINCHED BADLY WHEN TRYING TO REMOVE THE PUMP. NO BROKEN BONES. MAGNET HOUSING REQUIRED REPLACEMENT. TWO MINUTES PRIOR TO THE INCIDENT, ALL PRESENT WERE INSTRUCTED NOT TO ALLOW SAID PUMP INTO THE SCAN ROOM.

]]> By: Lisa C http://mrimetaldetector.com/blog/2009/09/has-fda-dumbed-down-maude-accident-database/comment-page-1/#comment-12004 Lisa C Sun, 12 Sep 2010 14:12:34 +0000 http://mrimetaldetector.com/blog/?p=583#comment-12004 I think all of you should email the whitehouse.gov and report the FDA MAUDE website as negligent. It's obvious the FDA is not addressing these problems! Of course...why would they??? Their the ones that approved it! Really makes sense...they have the fox guarding the hen house?!? I think all of you should email the whitehouse.gov and report the FDA MAUDE website as negligent. It’s obvious the FDA is not addressing these problems! Of course…why would they??? Their the ones that approved it! Really makes sense…they have the fox guarding the hen house?!?

]]> By: Nancy E. Bowling http://mrimetaldetector.com/blog/2009/09/has-fda-dumbed-down-maude-accident-database/comment-page-1/#comment-3098 Nancy E. Bowling Tue, 15 Dec 2009 10:24:00 +0000 http://mrimetaldetector.com/blog/?p=583#comment-3098 Yeah, okay. So they fixed it. But fixing the database and actually reading what's on it are two different things. Which one is it? Yeah, okay. So they fixed it. But fixing the database and actually reading what’s on it are two different things. Which one is it?

]]> By: Can We Still Call Them ‘Never Events’ When Accidents Happen So Frequently In MRI? « MRI Metal Detector Blog http://mrimetaldetector.com/blog/2009/09/has-fda-dumbed-down-maude-accident-database/comment-page-1/#comment-3037 Can We Still Call Them ‘Never Events’ When Accidents Happen So Frequently In MRI? « MRI Metal Detector Blog Mon, 07 Dec 2009 13:53:47 +0000 http://mrimetaldetector.com/blog/?p=583#comment-3037 [...] about the FDA and their online-accessible database of medical device accidents which, for months, appeared to be malfunctioning, and recently was repaired. Second, there was my post in which I identified 5 MRI ‘Never [...] [...] about the FDA and their online-accessible database of medical device accidents which, for months, appeared to be malfunctioning, and recently was repaired. Second, there was my post in which I identified 5 MRI ‘Never [...]

]]> By: Nancy E. Bowling http://mrimetaldetector.com/blog/2009/09/has-fda-dumbed-down-maude-accident-database/comment-page-1/#comment-3036 Nancy E. Bowling Mon, 07 Dec 2009 12:44:49 +0000 http://mrimetaldetector.com/blog/?p=583#comment-3036 Brian, I'm not sure you understand. Her VNS device did NOT malfunction. It was working exactly as it was suppossed to. This was the device that the FDA approved. What I don't understand is that the FDA was formed to regulate these devices and pharmaceuticals to assure us that they are safe for the public, right? I read Cyberonics "Conditions of Approval" document which very clearly stated that FAILURE TO COMPLY WITH ANY POST-APPROVAL REQUIREMENT CONSTITUTES FOR WITHDRAWAL OF APPROVAL OF PMA. When the FDA granted Cyberonics approval, two of the conditions were a 460-patient Post Market Dosing Study and a 1,000 patient Out-Come Registry. In November of 2008 the company submitted a proposal to the FDA to change the enrollment from 460 down to 330. These conditions are in P970003 doc# 98M-0140. They were given to a Class III medical device which MUST undergo an approval process that includes special controls, eg performance standards and general controls required of all devices, and, in addition to that, the device or product must meet a rigorous premarketing approval standard, which may delay the release of the product for months, even years. Since these conditions were given to them in 2005 they should have been near completion, not still discussing how to get out of them. Then in Master File No. H-05-2121 of the UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF TEXAS on page 14 [c] Defendants were well aware of the shortcomings of their own clinical studies, including the fact that a randomized & blinded study of the Vns system as therapy for TRD failed to yield statiscally significant results [page 44] when [CWI] checking on the study sites to see they followed protocol, only 3 of 26 sites did. Pages 80 & 81- failure to document death data properly and Report INV 01-0006, dated January 8, 2002 and Febuary 19, 2003, talks about prior knowledge of high lead impedance [which, by the way, has caused deaths] Every week I log onto the Maude Data Base and the death count and serious life-threatining injury count goes up, and yet, it seems to me that the FDA really doesn't have much authority over the situation. And Cyberonics knows that! Brian, I’m not sure you understand. Her VNS device did NOT malfunction. It was working exactly as it was suppossed to. This was the device that the FDA approved. What I don’t understand is that the FDA was formed to regulate these devices and pharmaceuticals to assure us that they are safe for the public, right? I read Cyberonics “Conditions of Approval” document which very clearly stated that FAILURE TO COMPLY WITH ANY POST-APPROVAL REQUIREMENT CONSTITUTES FOR WITHDRAWAL OF APPROVAL OF PMA. When the FDA granted Cyberonics approval, two of the conditions were a 460-patient Post Market Dosing Study and a 1,000 patient Out-Come Registry. In November of 2008 the company submitted a proposal to the FDA to change the enrollment from 460 down to 330. These conditions are in P970003 doc# 98M-0140. They were given to a Class III medical device which MUST undergo an approval process that includes special controls, eg performance standards and general controls required of all devices, and, in addition to that, the device or product must meet a rigorous premarketing approval standard, which may delay the release of the product for months, even years. Since these conditions were given to them in 2005 they should have been near completion, not still discussing how to get out of them. Then in Master File No. H-05-2121 of the UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF TEXAS on page 14 [c] Defendants were well aware of the shortcomings of their own clinical studies, including the fact that a randomized & blinded study of the Vns system as therapy for TRD failed to yield statiscally significant results [page 44] when [CWI] checking on the study sites to see they followed protocol, only 3 of 26 sites did. Pages 80 & 81- failure to document death data properly and Report INV 01-0006, dated January 8, 2002 and Febuary 19, 2003, talks about prior knowledge of high lead impedance [which, by the way, has caused deaths] Every week I log onto the Maude Data Base and the death count and serious life-threatining injury count goes up, and yet, it seems to me that the FDA really doesn’t have much authority over the situation. And Cyberonics knows that!

]]> By: Brian Todt http://mrimetaldetector.com/blog/2009/09/has-fda-dumbed-down-maude-accident-database/comment-page-1/#comment-2693 Brian Todt Tue, 10 Nov 2009 22:33:21 +0000 http://mrimetaldetector.com/blog/?p=583#comment-2693 In response to Nancy, you can rest assured that the FDA most assuredly does look carefully at all the reports of serious injury and death. They routinely challenge manufacturers for additional information, and persist until they are satisfied. This correspondence is mostly outside of the MDR reports that are captured in MAUDE. Also, an initial report often contains assumptions that are disproved upon investigation. But if a device malfunction occurs and causes patient harm, and it is likely to reoccur, you can bet the FDA will be all over it. On a related note, the FDA now posts on their web site "Please note: due to technical difficulties all fields may not currently be available..." Indeed we already had concluded that. In response to Nancy, you can rest assured that the FDA most assuredly does look carefully at all the reports of serious injury and death. They routinely challenge manufacturers for additional information, and persist until they are satisfied. This correspondence is mostly outside of the MDR reports that are captured in MAUDE. Also, an initial report often contains assumptions that are disproved upon investigation. But if a device malfunction occurs and causes patient harm, and it is likely to reoccur, you can bet the FDA will be all over it.

On a related note, the FDA now posts on their web site “Please note: due to technical difficulties all fields may not currently be available…” Indeed we already had concluded that.

]]> By: Nancy E. Bowling http://mrimetaldetector.com/blog/2009/09/has-fda-dumbed-down-maude-accident-database/comment-page-1/#comment-2666 Nancy E. Bowling Mon, 09 Nov 2009 12:30:19 +0000 http://mrimetaldetector.com/blog/?p=583#comment-2666 I have a question. Does anybody who has the authority to do anything about all these serious injuries and deaths that consumers and physicians are reporting ever actually do anything about them? Does either the FDA or the CDRH ever reconsider any of the approvals based on what is being reported? My sister had a VNS manufactured by Cyberonics implanted to control her seizures and it almost cost her her life, so I logged onto the Maude Data Base to see if this was just a fluke or if anyone else had any trouble with it. I could not believe the deaths and serious injuries that were listed going back 10 years for this device. So I did a little more research on its approval and found they have not even met the FDA's conditions of approval yet. This device was approved in 1997 for seizures and in 2005 for depression, but with conditions. Two of these conditions were a 1,000 patient 5-year outcome registry and a 450-patient postmarketing dosing study, and yet in a F1Q10 [Qtr End 07/24/09] Earnings Call Transcript, Daniel Moore is talking about his request to the FDA to reduce the amount of people they had to test. Are you kidding me? My sister was a registered nurse for Pete's sake making very good money and now she will be on social security for the rest of her life, and she's only 45. Every week I log onto the Maude Data Base and the death toll goes up along with the injury count. So like I said, does anybody in the FDA ever actually read these? I have a question. Does anybody who has the authority to do anything about all these serious injuries and deaths that consumers and physicians are reporting ever actually do anything about them? Does either the FDA or the CDRH ever reconsider any of the approvals based on what is being reported? My sister had a VNS manufactured by Cyberonics implanted to control her seizures and it almost cost her her life, so I logged onto the Maude Data Base to see if this was just a fluke or if anyone else had any trouble with it. I could not believe the deaths and serious injuries that were listed going back 10 years for this device. So I did a little more research on its approval and found they have not even met the FDA’s conditions of approval yet. This device was approved in 1997 for seizures and in 2005 for depression, but with conditions. Two of these conditions were a 1,000 patient 5-year outcome registry and a 450-patient postmarketing dosing study, and yet in a F1Q10 [Qtr End 07/24/09] Earnings Call Transcript, Daniel Moore is talking about his request to the FDA to reduce the amount of people they had to test. Are you kidding me? My sister was a registered nurse for Pete’s sake making very good money and now she will be on social security for the rest of her life, and she’s only 45. Every week I log onto the Maude Data Base and the death toll goes up along with the injury count. So like I said, does anybody in the FDA ever actually read these?

]]> By: Brian Todt http://mrimetaldetector.com/blog/2009/09/has-fda-dumbed-down-maude-accident-database/comment-page-1/#comment-2564 Brian Todt Wed, 28 Oct 2009 16:31:42 +0000 http://mrimetaldetector.com/blog/?p=583#comment-2564 On the FDA MAUDE search page, if you click on "Download Files" you will now see a last change date of 10/27/2009 at the bottom. This is interesting, because today their online search comes up with no event description for events that have FOITEXT in the files I downloaded a couple weeks ago. This implies that they might indeed be purging the event descriptions intentionally. One example (out of thousands) is report number MW5011960, which had an event description 2 weeks ago, and is now null. On the FDA MAUDE search page, if you click on “Download Files” you will now see a last change date of 10/27/2009 at the bottom. This is interesting, because today their online search comes up with no event description for events that have FOITEXT in the files I downloaded a couple weeks ago. This implies that they might indeed be purging the event descriptions intentionally. One example (out of thousands) is report number MW5011960, which had an event description 2 weeks ago, and is now null.

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