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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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dennis100
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« Reply #2 on: October 13, 2018, 04:43:14 AM »

Model Number 102R
Device Problem Device Operates Differently Than Expected
Event Date 06/10/2012
Event Type  Death   
Event Description
A vns patient's mother reported that the patient passed away on (b)(6) 2012 due to an unknown reason. No autopsy is being performed. The mother indicated that the funeral was going to be on (b)(6) 2012, and the funeral home was not going to explant the vns devices. The patient lived in a nursing home and was put on hospice care prior to her passing. The mother also mentioned that the patient had feeding tubes, and would always pull them out. The patient's vns was reported to be last checked in (b)(6) 2011, and after the appointment, they were notified that there was approximately seven months of battery life remaining. However, the patient's vns was typically managed by a different physician. It was also mentioned that the nursing home never used the vns magnets. Follow up with the patient's last treating physician revealed that they are uncertain about the relationship of the patient's death to vns. The patient was only seen in their clinic on (b)(6) 2011, then the patient followed up with an outside neurologist. The office was not aware of the patient's death. The patient had medically refractory seizures, however it was unknown how many seizures the patient averaged per month. The death follow up form was completed which indicated the patient suffered from epilepsy since birth, but the etiology is unknown but may be related to twin pregnancy. The patient's response to vns was unknown by this physician. Attempts for information from the patient's typically treating physician have been unsuccessful to date.
 
Event Description
Follow up with the neurologist's office revealed that the neurologist only evaluated this patient once on (b)(6) 2012. Diagnostics and interrogation was reportedly not performed on this date, but the nurse indicated that the clinic notes reported that the battery life was estimated to about 7 months, per manufacturer rough battery life estimation. The vns programming is not completed at their clinic. It was requested to follow up with the patient's primary care physician; however, attempts to obtain the primary care physician's name and contact information have been unsuccessful to date. Follow up with the nursing home for which the patient was living prior to passing revealed that the patient's death was not believed to be related to vns, however specifics were not provided. It was related to the patient's poor state of health (unrelated to vns).
 
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2012 and the patient's cause of death was infantile cerebral palsy, gangrene and other unspecified convulsions. A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of unlikely sudep. There is no allegation or other information indicating that the death is related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2651071
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