I'm a little bit confused. I just got on the Maude Data Base and typed in 1] death caused by Cyberonics vns device-2,360 2] death after vns implant-359 3]Cyberonics vns device causing death-2,680 4] life threatening injury after vns implant-283 5]psychosis after vns implant-21 6] psychiatric hospitalization after vns implant- 33 7] psychiatric hospitalization after Cyberonics vns implant- 29 Then there is another thing that bothers me. Take report# 1644487-2005-00753 10/06/2005 This was with model 102 and was reported by the manufacturer. It said the report was not sent to the FDA, the device was not returned to the manufacturer or available for evaluation and that further follow-up with the treating physician revealed that the death was not believed to be related to the vns system. If the device was not explanted or tested or evaluated, how can they possibly claim that it was not the cause? This is not just one report, either. I am talking report after report of devices that are not being explanted or evaluated and several of these models I've noticed now are on the recall list. I've read P970003 apr# 98M-0140 doc#[P970003S150] In which the post-approval requirements were suppossed to be [among other things] a 460-patient post-market dosing study and a 1,000 patient 5-year registry. Then in a Cyberonics F3Q09 Quarter End 01/23/09 Earnings Call Transcript Daniel Moore is discussing the proposal they submitted to the FDA to change the structure of the TRD post-approval study from 460 patients to 330. I can't understand this. These conditions were given in 2005 to a Class III medical device and in that approval document it very clearly states: FAILURE TO COMPLY WITH ANY POST-APPROVAL REQUIREMENT CONSTITUTES FOR WITHDRAWAL OF APPROVAL OF THE PMA. Obviously that document is just a formality. None of it means anything.