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Author Topic: Adrenal Glands  (Read 646 times)
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dennis100
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« on: May 15, 2018, 08:12:58 AM »

Model Number 101
Device Problem No Information
Event Date 07/27/2010
Event Type  Death  
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) 2004 and the patient's cause of death was potential sudep with epilepsy, unspecified, and sequelae of intracranial injury and other accidents. A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of definite sudep. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
It was reported by the physician's office that the patient has died due to an unknown reason. No other information regarding the patient's death was known by the office or the patient's last known physician. Attempts for a copy of the patient's death certificate have been unsuccessful to date.
 
Event Description
The requested death certificate has been received. The cause of death is listed as "sepsis", "cholecystihs", and "cholerithiasis" as contributing causes. Other significant contributing conditions were listed as: "aspiration pneumonia, seizure disorder, adrenal insufficiency, hypothyroidism. " no autopsy was performed. The manner of death is listed as "natural. " the patient died as an inpatient. The patient's vns is believed to have been buried with the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2265175
« Last Edit: May 16, 2018, 01:53:06 AM by dennis100 » Logged
dennis100
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« Reply #1 on: May 16, 2018, 01:54:00 AM »

Model Number 102
Event Date 06/04/2012
Event Type  Death   
Manufacturer Narrative
Analysis of programming history performed.
 
Event Description
On (b)(6) 2013 a sudep evaluation was performed by the manufacturer with the information available and it was determined that the patient¿s death is considered to be possibly sudep related.
 
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: atherosclerotic heart disease; benign neoplasm of adrenal gland; myocardial degeneration; cardiomegaly; atherosclerosis of aorta. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
It was reported that the patient had not been seen in a long time, and the treating physician was unknown. The company case manager searched online and found an obituary for the patient who passed away on (b)(6) 2012. The reason is unknown. The patient¿s previously treating physician moved a few years prior and no longer practices vns. The patient passed away outside of his care. Review of the company programming history database revealed the patient¿s last programming physician was another physician (on (b)(6) 2010). Attempts for additional information from this physician have been unsuccessful to date.
 
Event Description
Follow-up with the funeral home was done and they did not have the generator or lead for return.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3205872
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