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Author Topic: Tumor/Neuroma  (Read 6200 times)
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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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dennis100
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« Reply #36 on: November 09, 2019, 01:00:19 AM »

Model Number 101
Event Date 01/01/2005
Event Type  Injury   
Event Description
It was reported via clinic notes, that the pt had experienced several increases in seizures over the past few years and pain with stimulation. The pt's output current was decreased to 2. 75 ma. It was also noted that the pt had surgery for excision of an acoustic neuroma and some of the seizures began after this surgery in 2011. It was also noted that many of the seizures appear to be caused by stress and cannot be controlled with vns or medications. Attempts for further info have been unsuccessful to date.
 
Event Description
It was inadvertently reported previously that the seizures began in 2006, but they actually appear to have begun sometime in 2005 per clinic notes. Also, the seizures previously mentioned in 2011 are not applicable to this event as they occurred with a different generator and were reported under medwatch #1644487-2011-01619.
 
Manufacturer Narrative
Correction: it was inadvertently reported previously that the seizures began in 2006, but they actually appear to have begun sometime in 2005. Correction: the seizures previously mentioned in 2011 are not applicable to this event as they occurred with a different generator and were reported under medwatch #1644487-2011-01619.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2201796
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dennis100
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« Reply #37 on: November 09, 2019, 01:00:52 AM »

Model Number 304-20
Event Date 03/01/2010
Event Type  Injury   
Event Description
It was initially reported that the patient was recently turned on a few prior and was now experiencing some swelling in her neck and throat, and has been unable to turn her head. It was said that the patient was diagnosed by her treating neurologist that she has a neuroma. The patient was said to have been given a steroid injection, which provided some improvement. It was also indicated that the patient is experiencing some painful stimulation in the neck. No further details have made available on the events. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1698103
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dennis100
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« Reply #38 on: November 09, 2019, 01:01:28 AM »

Model Number 304-20
Device Problem Fracture
Event Date 10/03/2019
Event Type  Malfunction   
Event Description
It was reported that the patient's vns device registered a high impedance reading prior to a vns replacement case. During surgery, the surgeon observed no tie downs were used at previous implant to secure the electrodes on the vagus nerve. It was noted that the electrodes were free to move about on the nerve a bit, and this caused a lot of torque and manipulation of the lead and the nerve itself. The surgeon identified a small fracture near the electrodes. Once the old generator and lead were explanted, the surgeon initially observed high impedance on the newly implanted vns system. After further review, the surgeon observed excessive scar tissue around the nerve, which the surgeon assessed was likely due to the electrodes manipulating the nerve over the course of the previous device¿s implant. The surgeon removed most of the scar tissue, including a large chunk that he sent for biopsy for possible neuroma, and then reattached the electrodes to the nerve. Then diagnostics were done three more times and each time they were good. The surgeon then completed the surgery and everything was normal. The explanted products were discarded, and therefore the generator and lead will not be returned for product analysis. Further follow up with the physician confirmed that the mass sent for biopsy tested positive for neuroma. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9246027
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dennis100
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« Reply #39 on: November 09, 2019, 01:02:03 AM »

Model Number 103
Event Date 03/19/2014
Event Type  Injury   
Event Description
It was reported that a seizure caused the dehiscence. The patient underwent another revision on (b)(6) 2014. The physician indicated that a resection of a neuroma in both the generator site and electrode site occurred. The patient later underwent explant of both the generator and lead. No additional relevant information has been received to date.
 
Event Description
It was reported that the vns patient underwent surgery on (b)(6) 2014 due to inflammation, dehiscence, and extrusion of the lead at the generator site. In (b)(6) 2014, the patient presented with drainage at the generator site. The surgeon stated that no infection had developed and attributed the event to vns implant surgery. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4012570
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dennis100
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« Reply #40 on: November 09, 2019, 01:02:36 AM »

Model Number 302-20
Event Date 11/16/2011
Event Type  Malfunction   
Event Description
It was reported by a surgeon that high lead impedance was found after replacement of a patient's generator. The surgeon found that the lead was twisted near the generator site, and also that the patient had a damaged vagus nerve and a neuroma proximal of the lead next to the fixation area. The surgeon indicated that the patient was known to be a twiddler and it is suspected that the patient twisted the generator (as seen during surgery). The patient was described to be spastic and severely mentally disabled in accordance to the surgeon. X-rays were taken of the patient prior to surgery and no anomalies were noted on the review according to the treating neurologist.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2364121
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dennis100
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« Reply #41 on: November 09, 2019, 01:03:39 AM »

Model Number 302-20
Event Date 12/15/2005
Event Type  Injury   
Event Description
Initially, it was reported that during a vns system replacement surgery, it was observed that the patient's left vagus nerve was cut and that it presented with signs of having been cut for a long period of time. A neuroma was observed at the level of the cut which was at the lower end of the vagus nerve. No relationship of the cut to vns was noted at the time of initial report. It was later reported during a neurosurgeon expert meeting, that the diagnosis of a complete cut left nervus vagus with a neuroma was made during the replacement surgery. It was noted that the lesion was probably due to direct surgical trauma during the first implant procedure. It was noted that the patient had experienced partial improvement of epilepsy with vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3774040
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