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dennis100
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« on: July 16, 2016, 02:19:11 AM »

Model Number 102
Event Date 11/21/2006
Event Type Malfunction
Event Description
The patient was seen on (b)(6) 2013, and clinic notes dated (b)(6) 2013 were received. The notes indicated that the patient had a previous medical history of depression/anxiety, irritable bowel syndrome, fibromyalgia, and scoliosis. The patient's depression was initiated by a familial death. The patient attributes multiple problems to her vns, including a sensation of spark in her left occipital region, occasional choking sensation, stuttering speech, and memory problems. The patient also reports an occasional left-sided headache, occasional parethesias on the left side of her neck, weakness in her right hand, and balance problems. The patient was seen on (b)(6) 2013. Diagnostics were run and were within normal limits. Settings were provided.

Event Description
On (b)(4) 2012, it was reported that this vns patient wanted her device explanted. No additional information was provided. Surgery is likely, but has not occurred.

Event Description
On (b)(6) 2013, it was reported that this patient wanted her device removed due to choking, occasional stuttering, and memory problems that the patient attributes to vns. The patient also felt the device did not help with depression. No additional information was available. Surgery is likely but has not taken place.

Event Description
Additional information received from the physician revealed that the neurological issues the patient reported were mainly pain however the patient's chart was not available for him to confirm. The pain was not isolated to device stimulation. The physician did not have any additional information to provide.

Event Description
Additional information was received on (b)(4) 2012, when the patient reported that she was experiencing choking, burning at the top of the generator, memory loss, "zapping" on the left side of neck and back of her head and that she is not able to eat food properly. When she tried to disable the device using her magnet, the symptoms did not resolve. She stated that her settings were lowered however she is still having problems. The patient stated that she now has scoliosis and is on disability due to her issues with vns. Good faith attempts to obtain additional information from the patient's physician have been unsuccessful to date.

Manufacturer Narrative

Event Description
It was reported that a vns patient stated she developed a variety of neurological symptoms as a result of a device that she felt was broken resulting in pain and other issues. Per the patient, the neurologist she saw attributes all her symptoms to the device and advised her to have it explanted. On (b)(6) 2011, it was reported that the patient was complaining of pain even after the physician instructed her to place the magnet over the generator to temporarily inhibit stimulation. (b)(4) attempts to obtain additional information have been unsuccessful to date.

Event Description
Additional information was received stating that the vns patient was seeking to have her device explanted. The patient reported experiencing memory loss and losing her sense of direction. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2405008
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dennis100
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« Reply #1 on: August 10, 2016, 08:33:07 AM »

Model Number 102
Event Date 04/04/2011
Event Type Injury
Event Description
It was reported by a vns pt that after her prophylactic generator replacement surgery, she developed an allergic reaction to antibiotics prescribed by neurosurgeon as a precaution. The pt was hospitalized for 3 days ((b)(6) 2011). Also, while she was hospitalized, she was told that her ekg was abnormal which necessitated referral to cardiology, capture in mdr #1666487-2011-00976. Pt also reports hand tremor, cognitive issue and memory problems since the generator replacement. Good faith attempts to obtain more information from the treating neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2082998
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dennis100
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« Reply #2 on: May 09, 2018, 01:39:22 AM »

Model Number 102
Device Problem High impedance
Event Date 03/01/2017
Event Type  Malfunction   
Event Description
It was reported that the patient's device had high impedance during a clinic visit with the physician. The device was disabled at this time. The physician stated that the high impedance could be associated with the patient manipulating the generator. It was later reported that for the previous month the patient had experienced an increase in seizures, headaches, memory loss and trouble focusing. The increase in seizures was also attributed to the fact that the patient abruptly stopped antiepileptic medication without titration off. The patient attempted to use the vns magnet however she did not feel vns stimulation. The patient was referred for vns replacement surgery due to the high impedance. During the surgery, the patient's generator was replaced and the impedance value after replacement was within normal limits. Therefore, the lead was not replaced at that time. The explanted generator has not been received by the manufacturer to date. No additional relevant information has been received to date.
 
Manufacturer Narrative

Event Description
The generator was returned to the manufacturer and analysis was completed. The generator was tested with a known good lead and the lead was able to be fully inserted in the generator and function properly. The generator was also shown to measure impedance accurately and was able to deliver the programmed current as expected. The product analysis concluded proper functionality of the generator and that no abnormal performance or any other type of adverse condition was found.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6544281

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dennis100
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« Reply #3 on: May 31, 2018, 02:13:02 AM »

Model Number 102
Event Date 04/28/2008
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported on (b)(6) 2012, that a patient has felt a ringing in his left ear since surgery and indicated it interferes with his hearing. He has a scar at the generator site which is sensitive and painful. The scar at the generator is large and there is no scarring at the neck site. The patient is experiencing an irregular heartbeat with stimulation. He stated his heart has been observed as "skipping a beat" and states the device affects his memory in that he is unable to remember some things. He can also feel stimulation in his leg at times. Good faith attempts to obtain additional information have been unsuccessful to date.
 
Event Description
Additional information was received on (b)(6) 2012 when the neurologist's office reported that they have not seen the patient since 2008 so they would not be able to comment on the events reported by the patient. It is unknown who the patient will see at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2581381
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dennis100
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« Reply #4 on: June 23, 2018, 12:15:51 AM »

Model Number 304-20
Event Date 09/24/2014
Event Type  Injury   
Event Description
On 5/17/16 the physician reported that the patient did have a portion of their vagus nerve removed and then stitched back together again on (b)(6) 2014 during the full revision surgery that day.
 
Event Description
On (b)(6) 2016 the physician indicated that the patient's chocking sensation is from misfiring of the vns. He said that the memory issues are not applicable. All diagnostics were reported to be within normal limits with the last one performed on (b)(6) 2016. The physician turned off the patient's vns and the patient is considering having it removed and probably not replaced. The patient does not have a medical history of these events prior to vns. The only event preceding the onset of the chocking/painful stimulation is replacement of the vns. It was previously reported that the patient underwent a full revision on (b)(6) 2014 due to issue following a mammogram. The patient is still having discomfort in the neck with stimulation, so the physician indicated that he would like contact information for a vns surgeon for another opinion as the previous surgeon stated he would not do another revision for the patient. It was reported that a system diagnostics test had not been performed after the recent complaint of painful stimulation. Additional information was requested from the physician but no further information was received regarding whether diagnostics were performed since the replacement. On (b)(6) 2016 the patient's mother reported that the patient has been experiencing painful stimulation as well as profound breathing issues since the generator revision. The breathing issues are described as a strong choking sensation leading to gasping and can last up to 30 seconds at a time. The patient then reported that this issue typically presents when she turns her head to the left or the right and that it has happened "thousands of times" so she is used to the effects. She also is experiencing memory issues. The patient stated that she is now having an increase in seizures since her device was turned off on (b)(6) 2016. She said that at this time, she wants her system replaced because of the shocking and not wanting to have the stimulation turned back on. The patient noted that the magnet is still programmed on. She then indicated that she never had a problem with the previous system and when it was turned on following replacement, she started to feel shocking that was more over the generator site in the shoulder. The issues were also indicated as not occurring with stimulation on-times but always happened and resolved when the generator was programmed off. The patient said that her phrenic nerve is being stimulated per her neurologist, but it wasn't clear how he determined this. She indicated that when the magnet was swiped the day after it was painful, which is why she doesn't want to turn it back on. The patient stated that there is no room on the nerve because the surgeon removed part of her vagus nerve and stitched it back together, which she was insistent that this occurred as the surgeon told her this. The patient said that the old system was completely removed according to the x-rays. On (b)(6) 2016, a physician reported that the patient was hospitalized due to the increased in seizures. He said the primary reason for disablement was painful stimulation, shocking in her neck that occurred when she turned her head.
 
Manufacturer Narrative

Manufacturer Narrative
Inadvertently reported incorrect age on initial report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5498371
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dennis100
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« Reply #5 on: July 13, 2018, 02:19:21 AM »

Model Number 102
Event Date 04/04/2012
Event Type  Injury   
Event Description
Additional information was received on (b)(6), 2012 when the physician clarified that the vns patient does not have syncope or paralysis; it was an error in the notes.
 
Event Description
On (b)(6) 2012, clinic notes from a vns treating neurologist were received by the manufacturer. Review of the clinic notes dated (b)(6) 2012, reveal that the patient was experiencing an increase in seizures secondary to generic medications. The patient's last seizure was (b)(6) 2012 and his seizure semiology is described as his left side jerking for about 5 minutes followed by postictal sleep. The patient's seizure frequency is increase over the past 2 weeks to four seizures in 2 weeks. The patient stated that he does not feel his vns anymore. The patient's increased seizures started after his druggist changed his medication to generic carbatrol. The neurological section of the clinic notes state that the patient has syncope, pre-syncope, and paralysis. The relationship to vns was not stated. The psychiatric section states that the patient has anxiousness, depressed mood, impaired recent memory, and impaired remote memory. The vns was reported to be nearing end of life. Additional information has been requested but no further information has been received from the physician to date. A battery life calculation was performed with the programming history available which showed -1. 15 years until eri=yes.
 
Manufacturer Narrative
Type of report, corrected data: inadvertently did not check "day" on initial report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2602767
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dennis100
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« Reply #6 on: October 06, 2018, 05:04:28 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/13/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received for referral for replacement. Notes mention that the patient seizures have changed in the last 6 months and her brother noted that the patient¿s memory ¿is going crazy¿ and sometimes she is not able to talk correctly on the phone or in conversation. Directly after mentioning these issues, the discussion of vns replacement was noted. It appears they believe these issues may be associated with vns. The patient also noted more coughing recently and wasn¿t sure if this was related to vns stimulation. The physician¿s ma indicated that she suspects the seizures are vns related. The physician also believes that the patient¿s memory issues and inability to speak correctly is vns related but there was mention that the nonsense in conversation is her seizure presentation. No additional or relevant information has occurred to date. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7853645
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dennis100
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« Reply #7 on: December 17, 2018, 04:19:06 AM »

Model Number 103
Event Type  Malfunction   
Event Description
On (b)(6) 2013, the patient reported the following: vns not working, chest pain, shoulder pain, migraine headaches, difficulty sleeping, memory loss, and that his vns is sticking out due to a weight loss of 300 lbs. Follow up with the physician found that it was unknown if there was a relationship between these events to vns and it is unknown why the patient believes the vns is not working. The nurse stated that the patient has other medical problems and has multiple complaints. Additionally, they do not know why the patient had the weight loss and if it was intentional or unplanned. No other information was known.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3411788
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dennis100
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« Reply #8 on: December 18, 2018, 12:55:42 PM »

Model Number 103
Event Date 05/01/2013
Event Type  Injury   
Event Description
It was reported that the generator was replaced due to end of life on (b)(6) 2013. The generator was received for analysis on (b)(6) 2013. Analysis is underway, but has not been completed to date.

Event Description
Clinic notes dated (b)(6) 2013 note that the patient has experienced more frequent seizures and more forgetful since last visit. The physician increased the patient's medications. The notes on (b)(6) 2013 note that the patient has only experienced one seizure since the last visit. It was reported that the cause of the increase in seizures was due to the generator being at eri - yes. Attempts to obtain additional information have been unsuccessful to date.

Event Description
Analysis of the generator was completed on (b)(4) 2014. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. In the pa lab, the device output signal was monitored for more than 24-hrs, 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. The battery shows an ifi condition. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3487331
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dennis100
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« Reply #9 on: February 09, 2019, 02:05:06 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/19/2018
Event Type  Injury   
Event Description
It was reported that a patient was referred for generator replacement due to the patient experiencing pain, migraines, and memory loss. It was further noted that the device was "bothering" the patient. The patient was doing well with her medication and felt she did not need vns anymore. It was mentioned that the device was on "low dosing". The generator was explanted with no replacement. The device was not expected to be returned for analysis as the facility was a "no return" facility. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8241560
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dennis100
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« Reply #10 on: March 09, 2019, 02:27:27 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/07/2019
Event Type  Injury   
Event Description
It was reported via clinic notes received by the manufacturer that the patient was experiencing seizures about every other day, which was an increase. The patient felt that her memory had gotten worse with the increase in seizures. It was noted that the vns was still functioning but the battery life was beginning to wane. The patient was referred for vns replacement surgery. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8303438
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