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Author Topic: Cyberonics Says SUDEP  (Read 3731 times)
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dennis100
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« Reply #90 on: May 08, 2019, 10:02:05 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/09/2015
Event Type  Death   
Event Description
It was reported that the patient had passed away. Additional relevant information has not been received despite multiple attempts. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6378310
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dennis100
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« Reply #91 on: May 08, 2019, 10:02:36 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Death   
Event Description
The patient was reported to have passed away. An obituary could not be found. No additional relevant information has been received regarding patient's cause of death. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6526476
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dennis100
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« Reply #92 on: May 14, 2019, 12:19:32 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/04/2010
Event Type  Death   
Event Description
It was found that the patient passed away from an obituary. Additional relevant information has not been received. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6465546
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dennis100
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« Reply #93 on: May 14, 2019, 12:20:08 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/24/2015
Event Type  Death   
Event Description
It was reported by a company representative that this patient passed away. The representative found this from the neurologist office and the neurologist did not have any information on patient's cause of death. No additional relevant information has been received. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6455278
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dennis100
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« Reply #94 on: May 18, 2019, 12:04:43 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/19/2013
Event Type  Death   
Event Description
It was found that the patient passed away per an online obituary. No additional relevant information was received to date. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6569730
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dennis100
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« Reply #95 on: May 30, 2019, 05:26:49 AM »

Model Number 102
Device Problem Low Battery
Event Date 04/19/2017
Event Type  Death   
Event Description
Patient was referred for prophylactic generator replacement based on estimated battery life calculation (0 years remaining). Low battery warning was also observed per the clinic notes. Prior to generator replacement, however, the patient passed away. The family informed the surgeon's office that the patient would not be able to attend the consult as the passed away. Information was received from the patient's neurologist that the patient's response to vns therapy was seizure reduction. However, no details regarding the death was known to the neurologist. Patient has a history of 2nd generalized and complex partial seizures. Patient was compliant with medications and was on primidone, carbamazepine, lamotrigine, and few other medications. Patient was undergoing evaluation for replacement of vns due to generator failure/battery depletion. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6607900
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dennis100
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« Reply #96 on: June 28, 2019, 10:00:05 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/19/2017
Event Type  Death   
Manufacturer Narrative
 
Event Description
It was reported that the patient passed away in his sleep. No additional relevant information has been received to date. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7541963
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