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dennis100
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« on: January 09, 2019, 09:08:35 AM »

Model Number 105
Event Date 02/24/2016
Event Type  Injury   
Event Description
The patient was seen at the hospital with a need for a mri scan on (b)(6) 2016. At that time the patient was directed to their physician in order to proceed with device disablement prior to the mri. But it is unknown if the device was disabled prior to mri or if the mri was performed. On (b)(6) 2016, the patient was at the hospital due to experiencing chest pain. The patient also experienced discomfort in both neck and chest during stimulation, tingling sensations, voice alteration, nausea and issues with chewing. A nurse at the treating hospital requested that a company representative visit to turn the device off. A therapeutic consultant, who was present at the hospital at that time, disabled the device (both normal and magnet mode). Diagnostics were performed and reported to be within normal limits. It was unclear if the patient experienced a hear attack. Patient was asked to follow up with the neurologist once discharged. Additional relevant information has not been received.
 
Manufacturer Narrative

Event Description
Additional information was received that a physician at the hospital believed that the vns could have been contributing in someway to patient's cardiac problems. However, the patient has had a cardiac pacemaker for a long time and the neurologist does not feel that the vns has contributed in anyway to patient's heart problems. Per the neurologist, the vns has helped his seizures dramatically and is concerned with the idea of patient's generator being turned off. It is unknown if the vns was disabled prior to the mri. The diagnostic tests have always been within normal range in the past. The patient has a long history of cardiac problems. The patient is currently seen another neurologist. No other relevant information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5508303
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dennis100
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« Reply #1 on: January 09, 2019, 09:09:34 AM »

Model Number 105
Event Date 01/25/2014
Event Type  Injury   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
It was reported that the vns patient began experiencing pain at the electrode site on the left side of her face and neck on (b)(6) 2014. Additionally, the patient had difficulty chewing during stimulation. According to the neurologist, the relationship between the reported pain and vns is increased sensitivity to vns stimulation due to unknown etiology. The pain appeared to occur with stimulation. To preclude a serious injury, the neurologist lowered the patient¿s programmed settings. Product information is not available due to hospital policy. The available programming history did include any diagnostic results.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3677841
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dennis100
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« Reply #2 on: January 09, 2019, 09:10:31 AM »

Model Number 103
Event Date 06/27/2011
Event Type  Injury   
Event Description
On (b)(6) 2014 it was reported that the patient¿s physician retired and the patient was not seeing the other physician in the practice.
 
Manufacturer Narrative

Event Description
Clinic notes were received indicating that the vns patient went to the er and was admitted to the hospital on (b)(6) 2011. The patient had approximately 15 ¿episodes¿ that were different from the patient¿s normal seizure types. The episodes involved the patient chewing his tongue and losing consciousness. The patient was sleepier and more confused during the post ictal period. Since hospitalization, the patient had 1-2 seizures. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3942259
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dennis100
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« Reply #3 on: January 09, 2019, 09:12:26 AM »

Model Number 302-20
Event Date 09/28/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2012 it was reported that the vns patient has been referred for a revision surgery due to high impedance. Clinic notes from the patient's visit on (b)(6) 2012 were received. Clinic notes dated (b)(6) 2012 indicated that the patient has been seizure free since the lamictal dosage increase on (b)(6) 2012. Previously the patient had been averaging 1-2 seizures per week. The patient's settings were noted to be output current= 1. 75 ma/ frequency= 30 hz/ pulse width= 500 usec/on time= 30 sec/off time= 1. 8 min/magnet output current= 2 ma/ on time= 60 sec/ pulse width= 500 usec. A system diagnostic test was performed and passed with battery indicator = 100%, impedance value = 1873ohms, and ifi=no. Clinic notes dated (b)(6) 2012 stated that the patient continued to show a significant improvement in seizure control and only had 1-2 definite seizures per month with the most recent two having occurred on (b)(6) 2012. During these seizures, the patient has blank unresponsive staring with his eyes being "glazed over" and orolingual automatisms with chewing movements that last 3-4 minutes in duration. Previously the patient had been averaging 1-2 seizures per week. The patient was also reported to have been experiencing smaller events that the mother questions might be seizure related. During these spells, the patient has a sudden look of being anxious for a couple of seconds followed by heavy breathing without altered awareness. These are noted a couple of times per week. The patient's settings were noted to be output=1. 75 ma/frequency=30 hertz/pulse width= 500 microseconds/on time=30 seconds/off time=1. 8/ magnet output current= 2 ma/ on time= 60 sec/ pulse width= 500 usec. He has been tolerating stimulation without incident. A system diagnostic test was performed which indicated high impedance; impedance value=9067ohms and ifi=no. The physician stated that the patient has continued to have improved but incomplete control of seizures and his vns lead is fractured. On (b)(6) 2012 the physician reported that x-rays were taken but they will not be sent to the manufacturer for review. The physician also reported that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
Date of event; corrected data: additional information was received which changes the event date from what was initially reported.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the lead met specifications prior to distribution.
 
Event Description
Additional information was received on (b)(6), 2012 when it was discovered that the patient underwent a revision surgery on (b)(6), 2012. Product return attempts are underway but the explanted product has not been received for product analysis to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received on (b)(6), 2012 when it was reported that the hospital has the explanted generator but does not have the explanted lead to return to the manufacturer for product analysis. Although attempts were made for the return of the explanted product, they have not been received by the manufacturer for product analysis.
 
Event Description
On (b)(6) 2013 product analysis was completed on the explanted generator. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. According to the internal diagnostics that the generator performed, high impedance was first observed on (b)(6) 2012 when the impedance value went from 6515 ohms to 8396 ohms.
 
Event Description
Additional information was received on (b)(6), 2013 when the explanted generator was returned for product analysis. Product analysis is still underway and has not yet been completed. Review of manufacturing records confirmed device met specifications prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2832216
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dennis100
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« Reply #4 on: January 09, 2019, 09:13:48 AM »

Model Number 102
Device Problem Human-Device Interface Problem
Event Date 10/23/2015
Event Type  Injury   
Event Description
Additional information was received that the surgeon stated that everything appeared normal with the patient's implant after observing x-rays. The device had still not been turned on as of (b)(6) 2015. No additional relevant information has been obtained to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via voicemail message from the patient that the patient had a newer model generator implanted but was "having a lot of trouble" and "does not feel comfortable with the way things turned out". Additional information was received that the patient had a dehiscence wound at the generator site from her replacement surgery (b)(6) 2015. Additional information was received that the patient did not believe the surgeon properly closed the incision. Additional information was received that the patient is being referred for generator/lead replacement due to pain in her neck where the lead is and when she moves her head to the left or looks up. Patient has also reported difficulty eating and chewing and states that she has lost weight since implant. No known surgical interventions have occurred to date. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5250260
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dennis100
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« Reply #5 on: January 09, 2019, 09:14:50 AM »

Model Number 103
Event Date 07/28/2014
Event Type  Injury   
Event Description
An implant card was received and reported that the reason for generator replacement was battery depletion.
 
Event Description
Analysis was completed on the explanted generator. There were no performance or any other type of adverse conditions found with the pulse generator. The device output signal was monitored for more than 24-hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.
 
Event Description
Clinic notes were received indicating that the vns patient had been experiencing an increase in seizures for the past three weeks prior to his office visit on (b)(6) 2014. The patient also began having several generalized tonic-clonic seizures which have not been observed while the patient has had vns. Following vns, the patient has had three primary seizure types: (1) tonic movements of the arms with head deviation to the left, (2) chewing automatisms with head bobbing of the head and neck, and (3) facial grimacing. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The patient had generator replacement on (b)(6) 2015. The generator was received by the manufacturer for analysis. However, analysis has not been completed to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4184637
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dennis100
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« Reply #6 on: January 09, 2019, 09:15:55 AM »

Model Number 103
Event Date 05/24/2011
Event Type  Injury   
Event Description
Additional information was received on (b)(4) 2012, indicating that the patient had a vns removal surgery (b)(6) days prior on (b)(6) 2012. It is unclear at this time if only the generator was removed or if the lead was removed also. Attempts for product return and additional information are underway.
 
Event Description
Additional information was received on (b)(4) 2012, indicating that the explanted products were discarded. It was also confirmed that the generator and most of the lead were removed during the surgery. The electrodes however remained on the nerve.
 
Manufacturer Narrative

Event Description
It was reported by the patient that he was experiencing some pain and swelling in his left face that was making it difficult to eat and chew. The patient indicated that he wished to have his device explanted. The patient was then scheduled for a consult with a surgeon to have the device removed. Follow up with a nurse at the patient's treating neurologist's office revealed that the patient has been in pain for a while and that the device has been off for about a year. She indicated that she has not seen the patient since his consult with the surgeon, but she has spoken with him and he seems happy to have the device taken out. She indicated that they are unsure is this is just the patient, or if the device may have been implanted incorrectly, but she indicated that the patient does seem to be in legitimate discomfort. She was not able to provide any additional information. The patient had previously reported issues with pain, pain with stimulation, and voice alterations, starting following a lead replacement in (b)(6) 2011, however at the time these were thought to be mild and no interventions were taken. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2616944
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