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1997 Neurological Devices Panel
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<p>[QUOTE="Anonymous, post: 3833963"]1997 FDA CDRH Neurological Devices Panel</p><p><br /></p><p>DR. DUFFELL: I mean, I can comment briefly before Marty makes his statement that, I mean, certainly the intent of the company to make sure that the individuals who implant and treat with the device are adequately trained, and one of the things that we are striving and working with the agency over the labelling is to make sure that the labelling, of course, very appropriately says what the device is and is not capable of doing so that the expectations will be right. We're not interested in seeing this thing prescribed like aspirin for the treatment of epilepsy. It would be counterproductive to our commercial success years from now to have that happen.</p><p><br /></p><p>Pg 101</p><p><a href="http://www.fda.gov/ohrms/dockets/AC/97/transcpt/3299t1.pdf" target="_blank" class="externalLink ProxyLink" data-proxy-href="http://www.fda.gov/ohrms/dockets/AC/97/transcpt/3299t1.pdf" rel="nofollow">http://www.fda.gov/ohrms/dockets/AC/97/transcpt/3299t1.pdf</a></p><p>______________________________________________________________</p><p><br /></p><p>Model Number 102 </p><p>Event Date 11/01/2002 </p><p>Event Type Injury Patient Outcome Life Threatening; </p><p>Manufacturer Narrative </p><p>Report is incomplete because attempt to obtain additional information has been unsuccessful to date. </p><p>Event Description </p><p>Patient has had an increase in seizures since their implant. The patient had been having 1 seizure every month or every other month and is now having 2-3 seizures a month. </p><p><br /></p><p><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=448108" target="_blank" class="externalLink ProxyLink" data-proxy-href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=448108" rel="nofollow">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=448108</a></p><p><br /></p><p>Event Date 01/01/2003 </p><p>Event Type Injury Patient Outcome Life Threatening; </p><p>Event Description </p><p>Reporter indicated that the pt had experienced a total of 13 seizures the year prior and that pt had only experienced a total of 5 seizures 3 years before, prior to being implanted with vns therapy system. </p><p>Manufacturer Narrative </p><p>Report is incomplete due to the anonymous nature of the reported event. The pt did not give their name at the time of the initial report. </p><p><br /></p><p><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=550791" target="_blank" class="externalLink ProxyLink" data-proxy-href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=550791" rel="nofollow">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=550791</a></p><p><br /></p><p>Model Number 102 </p><p>Event Date 10/01/2003 </p><p>Event Type Injury Patient Outcome Life Threatening; Required Intervention </p><p>Event Description </p><p>Further follow-up revealed that the patient wants to have the device programmed to off and possibly explanted. Neurologist is considering programming the device to off. </p><p>Event Description </p><p>Reporter indicated that vns pt had experienced an increase in seizures since stimulation was initital. It was reported that pre-vns implant, the pt had one seizure per year. The pt has had approximately one seizure per week since initiation of vns therapy and that there had been no recent changes to their drug regimen. Further follow-up revealed that treating neurologist plans to increase vns settings and possibly decrease anti-epileptic medications. Neurologist indicated that the relationship between the vns therapy system and the reported event was unknown. The pt is still with increased seizures. </p><p>Event Description </p><p>Further follow-up revealed that the pt has been seizure free for approximately 4 months. Neurologist indicated that the pt has likey experienced greater benefits from vns therapy than the pt realizes. The cause of the reported increased seizures in unknown due to conflicting information from the pt and neurologist. </p><p><br /></p><p><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=508838" target="_blank" class="externalLink ProxyLink" data-proxy-href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=508838" rel="nofollow">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=508838</a></p><p><br /></p><p>Model Number 102 </p><p>Event Date 03/01/2004 </p><p>Event Type Injury Patient Outcome Life Threatening; </p><p>Event Description </p><p>Reporter indicated that pt has recently experienced an increase in seizures. It was reported that the pt experienced 1-2 seizures per year prior to vns implant and that pt recently experienced 3 seizures within one month. Treating neurologist indicated that the pt was doing fine and that the reported event was not related to the vns. The pt's seizures types had not changed. The pt's health condition is reportedly not worsening and there were no environmetal stimuli that may have contributed to the increase in seizure activity. Neurologist indicated that programming the pt's device to off resulted in no change to the pt's condition or symptoms. </p><p><br /></p><p><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522645" target="_blank" class="externalLink ProxyLink" data-proxy-href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522645" rel="nofollow">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522645</a>[/QUOTE]</p><p><br /></p>
[QUOTE="Anonymous, post: 3833963"]1997 FDA CDRH Neurological Devices Panel DR. DUFFELL: I mean, I can comment briefly before Marty makes his statement that, I mean, certainly the intent of the company to make sure that the individuals who implant and treat with the device are adequately trained, and one of the things that we are striving and working with the agency over the labelling is to make sure that the labelling, of course, very appropriately says what the device is and is not capable of doing so that the expectations will be right. We're not interested in seeing this thing prescribed like aspirin for the treatment of epilepsy. It would be counterproductive to our commercial success years from now to have that happen. Pg 101 [url]http://www.fda.gov/ohrms/dockets/AC/97/transcpt/3299t1.pdf[/url] ______________________________________________________________ Model Number 102 Event Date 11/01/2002 Event Type Injury Patient Outcome Life Threatening; Manufacturer Narrative Report is incomplete because attempt to obtain additional information has been unsuccessful to date. Event Description Patient has had an increase in seizures since their implant. The patient had been having 1 seizure every month or every other month and is now having 2-3 seizures a month. [url]http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=448108[/url] Event Date 01/01/2003 Event Type Injury Patient Outcome Life Threatening; Event Description Reporter indicated that the pt had experienced a total of 13 seizures the year prior and that pt had only experienced a total of 5 seizures 3 years before, prior to being implanted with vns therapy system. Manufacturer Narrative Report is incomplete due to the anonymous nature of the reported event. The pt did not give their name at the time of the initial report. [url]http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=550791[/url] Model Number 102 Event Date 10/01/2003 Event Type Injury Patient Outcome Life Threatening; Required Intervention Event Description Further follow-up revealed that the patient wants to have the device programmed to off and possibly explanted. Neurologist is considering programming the device to off. Event Description Reporter indicated that vns pt had experienced an increase in seizures since stimulation was initital. It was reported that pre-vns implant, the pt had one seizure per year. The pt has had approximately one seizure per week since initiation of vns therapy and that there had been no recent changes to their drug regimen. Further follow-up revealed that treating neurologist plans to increase vns settings and possibly decrease anti-epileptic medications. Neurologist indicated that the relationship between the vns therapy system and the reported event was unknown. The pt is still with increased seizures. Event Description Further follow-up revealed that the pt has been seizure free for approximately 4 months. Neurologist indicated that the pt has likey experienced greater benefits from vns therapy than the pt realizes. The cause of the reported increased seizures in unknown due to conflicting information from the pt and neurologist. [url]http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=508838[/url] Model Number 102 Event Date 03/01/2004 Event Type Injury Patient Outcome Life Threatening; Event Description Reporter indicated that pt has recently experienced an increase in seizures. It was reported that the pt experienced 1-2 seizures per year prior to vns implant and that pt recently experienced 3 seizures within one month. Treating neurologist indicated that the pt was doing fine and that the reported event was not related to the vns. The pt's seizures types had not changed. The pt's health condition is reportedly not worsening and there were no environmetal stimuli that may have contributed to the increase in seizure activity. Neurologist indicated that programming the pt's device to off resulted in no change to the pt's condition or symptoms. [url]http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522645[/url][/QUOTE]
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Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
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Medical Equipment/Device Sales
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Cyberonics
>
1997 Neurological Devices Panel
>
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Medical Equipment/Device Sales
>
Cyberonics
>
1997 Neurological Devices Panel
>