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dennis100
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« Reply #30 on: November 20, 2018, 08:04:48 AM »

Model
« Last Edit: January 25, 2019, 08:39:51 AM by dennis100 » Logged
dennis100
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« Reply #31 on: December 09, 2018, 03:33:39 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/03/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that during pre-op for an unrelated surgical procedure to remove the patient's thyroid that her ent physician diagnosed her with vocal cord paralysis. The patient reported that she had multiple surgeries on her neck to remove tumors. The vocal cord paralysis occurred in left vocal cord location, and the physician assessed that the cause of the vocal cord paralysis was the vns device surgery. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8061479
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dennis100
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« Reply #32 on: December 09, 2018, 03:34:16 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/09/2011
Event Type  Malfunction   
Event Description
It was initially reported via clinic notes received that the patient experienced an increase in seizures which were attributed to the patient's tumor. However, clinic notes were received years later which indicated that the patient's increase in seizures, which was present since vns implantation surgery, did not resolve even after laser ablation of the residual tumor. Follow up with the patient's neurologist had revealed that the vns was efficacious for the patient. The patient later underwent vns generator replacement surgery due to the desire for the latest generator model. The explanted generator was received by the manufacturer. Analysis identified no performance or any other type of adverse condition with the generator. The generator performed according to functional specifications. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8061994
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dennis100
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« Reply #33 on: January 18, 2019, 03:21:28 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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dennis100
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« Reply #34 on: March 06, 2019, 01:46:57 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/12/2018
Event Type  Injury   
Event Description
The patient reported that she had come vocal cord paralysis. The available programming history showed proper device functionality. No further relevant information has been received to date.
 
Event Description
The patient reported that their oncologist stated that they had right sided vocal cord damage after a biopsy on a thyroid tumor. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7492606
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dennis100
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« Reply #35 on: April 24, 2019, 02:28:44 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/23/2016
Event Type  Death   
Event Description
It was reported by the patient's previous treating physician upon patient end of service follow-up that he was "pretty sure" that the patient had passed away. Follow-up with this office found that they didn't have official record of this death in their files. No further relevant information has been received to date. The suspect product has not been received to date.
 
Event Description
An obituary verified that the patient passed away. Follow-up with the funeral home determined that the cause of death was neoplasm of the lung, with significant other factors being cerebral palsy, severe scoliosis, recurrent aspiration pneumonia, mental retardation, and seizure disorder. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6580098
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