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FDA Failing to Monitor Safety of Medical Devices
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<p>[QUOTE="Anonymous, post: 3724257"]Correction to post #6</p><p><br /></p><p>954 VNS deaths listed in MAUDE (As of 10/20/10)</p><p><br /></p><p>102 of those deaths are classified as possible, probable, and definite SUDEP</p><p><br /></p><p>*SUDEP is estimated to be 1 per 100 for patients with symptomatic seizures and 1 per 1,000 for patients with idiopathic seizures.</p><p><br /></p><p>That shows you are AT LEAST 10 times more likely to die of SUDEP with a VNS than with out it.</p><p><br /></p><p>And let's not forget about the 232 reports that do not mention a cause of death. How the hell can the FDA let Cyberonics get away with that? Read the reports for yourself if anyone doesn't believe me. The MAUDE reports are easy enough to find on the FDA site. The FDA's handling of the VNS is a real fine testament as to how they are protecting the welfare of the American public.</p><p><br /></p><p><br /></p><p>Dennis Fegan</p><p> </p><p> </p><p> </p><p>*eMedicine[/QUOTE]</p><p><br /></p>
[QUOTE="Anonymous, post: 3724257"]Correction to post #6 954 VNS deaths listed in MAUDE (As of 10/20/10) 102 of those deaths are classified as possible, probable, and definite SUDEP *SUDEP is estimated to be 1 per 100 for patients with symptomatic seizures and 1 per 1,000 for patients with idiopathic seizures. That shows you are AT LEAST 10 times more likely to die of SUDEP with a VNS than with out it. And let's not forget about the 232 reports that do not mention a cause of death. How the hell can the FDA let Cyberonics get away with that? Read the reports for yourself if anyone doesn't believe me. The MAUDE reports are easy enough to find on the FDA site. The FDA's handling of the VNS is a real fine testament as to how they are protecting the welfare of the American public. Dennis Fegan *eMedicine[/QUOTE]
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Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Medical Equipment/Device Sales
>
Cyberonics
>
FDA Failing to Monitor Safety of Medical Devices
>
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Medical Equipment/Device Sales
>
Cyberonics
>
FDA Failing to Monitor Safety of Medical Devices
>