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dennis100
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« on: May 17, 2018, 02:22:54 AM »

Model Number 102
Event Date 04/07/2010
Event Type  Death   
Event Description
Company rep became aware that epileptic vns patient passed away on (b)(6), 2010. F/u with funeral home revealed that vns device was buried with the deceased. The cause of death in the death certificate was mentioned as: sepsis/septic shock (48 hours), gangrenes left foot (1 week), atherosclerotic peripheral vascular disease (aspvd) (1 year). Also, no autopsy was performed. Good faith attempts with the pt's treating neurologist have been unsuccessful to date to question the relationship of death to vns device. Sudep eval was conducted by mfr and based on the available info, it has been determined not to be sudep since the death was not sudden or unexpected. The dhr for the lead and generator were reviewed and sterility prior to shipment was confirmed.
 
Manufacturer Narrative
Eval, method: device mfg records were reviewed. Results: review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1938703
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dennis100
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« Reply #1 on: May 17, 2018, 02:23:48 AM »

Model Number 103
Event Date 03/02/2011
Event Type  Injury   
Event Description
On (b)(6) 2011 a treating physician reported to the manufacturer's consultant that their vns patient was experiencing a "drooping foot". Which was reported to have been caused by vascular damage from the outside appearance of the patient's leg. This is causing the patient to have walking difficulties on the left side. The physician reported that during the patient's initial implant surgery on (b)(6) 2011, a tourniquet was placed on the patient's left foreleg and remained in place for eight hours. The treating physician does not know at this time why this was put in place and remained on the patient for eight hours. The physician is concerned that the patient is going to develop gangrene. The physician reported that the patient has been scheduled for vascular studies. The patient has a foot brace to assist with some of her bearing and stability functioning. The patient has been scheduled for physical and operation therapy but there is likely a poor prognosis. The tourniquet was placed by the anesthesiologist prior to surgery and then left in place for several hours per their treating physician. The patient has homological deficits and vascular deficits, but the exact reason for applying the tourniquet is not known by their treating physician at this time. If further information is received it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2045121
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