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dennis100
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« Reply #90 on: September 22, 2017, 01:21:24 AM »

Model Number 102
Event Date 04/01/2012
Event Type  Injury   
Event Description
The patient's explanted generator and lead were retuned on (b)(6) 2012. A 'return product form' indicated that the device were explanted due to prophylactic replacement and because the patient did not feel magnet mode stimulation consistently, along with increasing symptoms. Evaluation of the explanted pulse generator's reed switch was performed on the test bench, which confirmed normal, expected reed switch function and magnet current with magnet activation. 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. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Follow-up on (b)(6) 2012, showed that the lead was explanted due to a lead discontinuity. Diagnostics from (b)(6) 2012, were also provided. This lead event, along with product analysis results for the explanted lead, is captured in mfr. Report #1644487-2012-02507. Additional follow-up with the initial reporter showed that the patient's events had not resolved since revision. The patient still had the feeling that she was going to have a seizure daily; however, the patient would also feel anxious during these events, so it was difficult to say what the patient was actually experiencing. The patient could also not feel magnet mode stimulation. This was attributed to the patient's current settings being lower than pre-revision settings. The patient was slowly being ramped up. The patient's pre-operative settings and settings from her most recent appointment ((b)(6) 2012) were provided.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2012, a nurse reported that this vns patient could not feel magnet mode stimulation. The patient did report an inability to perceive normal mode stimulation. The nurse also reported that the patient complained of feeling "seizurey. " this was clarified to mean an increase in seizures. The patient's diagnostics were provided (date unknown). The patient's settings from (b)(6) 2011, (b)(6) 2012, and earlier were provided. A battery life calculation was performed on (b)(6) 2012, with 1. 6 years remaining until eri = yes. On (b)(6) 2012, the patient's nurse provided the following information. The increase in seizures was first observed in (b)(6) 2012. The patient was brought into the hospital for a possible seizure, associated with volume depletion/dehydration. The patient's constant feeling of being "seizurey" started within the past month. The nurse stated that it is unclear if these are prodromal symptoms and/or partial seizures. The symptoms consist of room spinning, numbness left side of head, confusion, and being scared. The patient has a history of mesial temporal sclerosis by mri and generalized activity on eeg. The nurse was unable to get an accurate count of the events. The nurse stated that while diagnostic testing is within normal limits, she presumed that the change in stimulation sensation and increased events are likely related to battery reaching end of service. As intervention, the patient's pulsewidth was decreased on (b)(6) 2012, and the patient's keppra dose was increased on (b)(6) 2012. Prophylactic replacement of generator was also being planned. No information was provided regarding the comparison to pre-vns seizure levels. In response to causal/contributory programming changes or events occurring prior to the increase in seizures, the nurse stated that the patient was admitted to the hospital in (b)(6) 2012, for dizziness followed by loss of consciousness. There was no clear cause, but the patient was hyponatremic, had a subsequent confusion episode and a possible seizure associated with dehydration. Within past month, there have been other possible lifestyle triggers but these were not new. The failure to perceive magnet mode stimulation was first observed within the past month. The patient reportedly uses the magnet frequently and reports being unable to feel magnet stimulation in past month. Previously, she had been able to feel it. No patient manipulation or trauma occurred that is believed to have caused/contributed to the stimulation not perceived. The patient's magnet mode diagnostics were not run. On (b)(6) 2012, the patient underwent surgery. Attempts for product return have been unsuccessful. An additional battery life calculation was performed on (b)(6) 2012, with updated data. The results indicated 1. 69 years to eri=yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2702307
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dennis100
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« Reply #91 on: October 02, 2017, 12:31:04 AM »

Model Number 102
Event Date 01/04/2013
Event Type  Injury   
Event Description
The explant hospital reported that the generator is not available to return to the manufacturer for analysis.
 
Event Description
The patient reported that it was known before he moved that he had a broken wire in his neck. The patient reported that he was seen by a neurosurgeon who recommended removal of the vns system after the consultation and review of the patient's previous medical records. It is unknown if device diagnostics were performed at the consultation.
 
Event Description
Further follow-up revealed that the physician described the "generator leakage" as a discomfort sensation like small shocks and itching. The physician reported that he has not seen the patient again for follow-up. It was reported that the patient did not show up for the surgical consult. Surgery may occur in the future; however, it has not occurred to date. It was reported that the patient moved to a different state.
 
Event Description
It was reported that the vns patient was experiencing signs of "generator leakage". The physician reported that the patient was experiencing the same symptoms as the patient experienced in 2011 that the patient underwent generator replacement for (reference mfr. Report # 1644487-2011-01472). The physician indicated that the patient is experiencing a constant tingling and burning sensation around the generator with the new generator. The physician reported that diagnostic testing was "ok". X-rays were taken and sent to device manufacturer for review. No gross lead fractures were visualized; however, the presence of an unpronounced lead discontinuity cannot be ruled out. The patient may be sent for surgical consult; however, no appointments have been scheduled at this time. It is unknown what the physician means by "generator leakage". Attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. (b)(4).
 
Event Description
It was reported that the patient underwent vns removal due to pain, burning and discomfort. Good faith attempts for additional, relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the surgeon. It was reported that the device was also explanted (not replaced) due to migration on (b)(6) 2014 for patient comfort. It was unknown when the weight loss and subsequent device migration began. The generator and portion of the lead were removed on (b)(6) 2014. The migration event was also previously reported in mfg report # mfg report #: 1644487-2013-00218, which has since been determined through the new information received to be related to the events in this report.
 
Event Description
The patient has been scheduled for surgical consult. Surgery is likely; however, has not occurred to date.
 
Event Description
It was reported that the patient underwent vns placement surgery on (b)(6) 2015. A new lead and generator were placed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2930499
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dennis100
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« Reply #92 on: October 04, 2017, 01:00:38 AM »

Model Number 103
Event Date 12/10/2012
Event Type  Malfunction   
Event Description
Further review of the operative notes revealed that the vns "device was retested, turned off" during surgery. The company representative followed-up with the surgeon's clinic and reported that the system diagnostic test was performed in surgery without the lead being connected to the generator. Then, the device was programmed on, and a subsequent system diagnostic test was not performed. The company representative reviewed the steps for programming vns devices in the operating room as indicated in labeling. From the available information, it appears that the surgeon performed a system diagnostic test before plugging the generator into the lead. The stored impedance value (from the final electrical test in manufacturing) will not clear until diagnostic testing is performed after connecting the generator and lead. If the device is programmed on prior to diagnostic testing, a high impedance warning message will appear. As there was no testing performed in the operating room, this message was obtained at the patient's first follow-up visit when the device was programmed on and prior to diagnostics. Manufacturer labeling indicates the generator and lead should be connected prior to performing system diagnostics.
 
Manufacturer Narrative

Event Description
The surgeon's office reported that the patient was seen in the neurologist's office on (b)(6) 2012 and presented with high lead impedance (impedance value 62; 10,000 ohms) upon performing diagnostic testing. The patient's device had not yet been turned on since vns initial implant surgery on (b)(6) 2012. The patient was referred back to the surgeon for evaluation. The surgeon's office reported that it was believed that the diagnostics at the time of implant were fine, and the patient did not report any trauma or event that could have precipitated an issue with the lead. The company representative saw the patient on (b)(6) 2012 and interrogated her device and performed system diagnostics. Diagnostics were within normal limits. The impedance value ranged between 2700-2900 ohms. The device was set at 0ma but he programmed her up to perform the test. The patient is difficult to communicate with but she did feel a tingle in her throat. It was clarified that the surgeon did not see the high impedance at time of implant, and the high impedance was only observed on (b)(6) 2012 by the neurologist. Operative notes were received from medical records which indicated that the vns system was tested in during surgery, and there was no note that diagnostics resulted in out of limit results. Attempts for a copy of the surgeon's flashcard have been unsuccessful to date to assess the specific programming completed on the date of surgery and the system diagnostic results following implant.
 
Manufacturer Narrative
Brand name, corrected data: with the new information, the suspect medical device is the generator and therefore the initial report inadvertently reported the brand name incorrectly as it was initially for the lead. Type of device name, corrected data: with the new information, the suspect medical device is the generator and therefore the initial report inadvertently reported the brand name incorrectly as it was initially for the lead. Model #, serial #, lot #, expiration date, corrected data: with the new information, the suspect medical device is the generator and therefore the initial report inadvertently reported the device information incorrectly as it was initially for the lead. Device manufacture date, corrected data: with the new information, the suspect medical device is the generator and therefore the initial report inadvertently reported the manufacturer date incorrectly as it was initially for the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2901503
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dennis100
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« Reply #93 on: October 05, 2017, 12:48:46 AM »

Model Number 102
Event Date 02/28/2012
Event Type  Malfunction   
Manufacturer Narrative
(b)(4). Outcomes attributed to adverse event (check all that apply). (b)(4).
 
Event Description
Additional information was received from the physician who stated that the patient experiences a continued four to eight seizures per month. The patient had the seizure in (b)(6) 2012 and the patient reports numbness on (b)(6) 2012 and (b)(6) 2013. However, it was reported that both the increase in seizures and change in seizure pattern were not related to vns. In regards to interventions, the physician stated that there was no injury and that the vns settings were increased on (b)(6) 2013 to 3. 5ma output current. There is no relationship between the increase in seizure frequency to pre-vns baseline levels and the patient does not have multiple seizure types. The increased seizures and change in seizure pattern are not related to vns programming per the physician. Clinic notes dated (b)(6) 2013 state that the patient has had no problems with medications or with vns. The patient's last settings from (b)(6) 2013 were provided as 3. 5ma output current, 20hz signal frequency, 250 micro seconds pulsewidth, 30 seconds on time, 5. 0 minutes off time, 3. 5ma magnet output current, 60 seconds magnet on time, and 500 microseconds magnet pulsewidth. No diagnostic information was provided.
 
Manufacturer Narrative

Event Description
On (b)(6) 2012 the physician's office stated that the patient was scheduled for a visit in march and to follow up after this time. Additional attempts for information have been made; however, they have been unsuccessful. No additional information has been provided.
 
Event Description
Clinic notes dated (b)(6) 2012 state that the patient was seen for follow-up in regards to her intractable generalized tonic-clonic and partial seizures. The patient's medications were listed and it was stated that she quit one medication. It was then noted that the patient has had an increasing number of seizures. Notes dated (b)(6) 2012 indicate that the patient's seizures appear to be increasing in severity, but still only happen a few times a month. However, further in the notes the physician reiterates that the patient has had an increasing number of seizures. It was stated that the patient's medication levels would be checked to determine if any doses should be changed. On (b)(6) 2012, the patient was seen again and it was stated in clinic notes that she was doing good. Per the notes, the patient's seizures continue at about four to eight per month and that the current frequency has been stable over the last several years. The patient continues on the same medications and it is stated that the patient's epilepsy has improved; however, there are still breakthrough seizures. It is unknown what the relationship of these increased seizure events and increased seizure intensity are to vns therapy. It is also unknown what the relationship of the increased frequency is to pre-vns levels. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2963437
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dennis100
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« Reply #94 on: October 06, 2017, 02:06:31 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 07/10/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that this patient is experiencing vocal cord paralysis. The surgeon believes it might be due to the vns strangulating the nerve. Therefore a vns lead revision occurred to determine if nerve strangulation is the cause. It was later reported that the patient began having sharp pains up her left ear to her left suboccipital area when her output current was increased. The patient had numbness of her left neck, left throat and left tongue. This made swallowing difficult. This did not get better with time, and when the output current was turned back down, she did not feel any stimulation unless her head was tilted to the left. It was mentioned that the doctor reported that the patient's nerve was pretty sizeable. The sharp pain that led to the patient's ear and suboccipital area was occurring with stimulation. It was also reported that it was too early to know the cause of painful stimulation, numbness, and vocal cord paralysis. The doctor spent 8 hours in the operating room probing the patient to determine what to do, and decided to cut the anchor tether, and snipped off the end of the positive electrode, and per the doctor, he did not cut any wire. He also believed the negative electrode was kinked and he fixed that. Overall the doctor kept the implanted lead intact with some modifications. The patient's generator was programmed off to allow the nerve to rest after surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6878406
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dennis100
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« Reply #95 on: October 07, 2017, 02:02:24 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 07/26/2017
Event Type  Injury   
Event Description
It was reported that the patient was experiencing numbness and pain under his arm following vns implant surgery. The patient was initially prescribed pain medication however this did not provide the patient any relief from the pain. It was later reported that the patient's neck and chest incisions from the surgery were not healing well. The patient was then taken to surgery for wound debridement and incision revision. Manufacturing records for the lead and generator were reviewed and confirmed that both devices were sterilized prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6853405
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dennis100
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« Reply #96 on: October 13, 2017, 12:34:06 AM »

Model Number 102
Event Date 09/01/2012
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
The patient reported her experience to the fda in medwatch report mw5061274. The patient reported the following: "the last surgery i had was to insert a vagus nerve stimulator, vns made by cyberonics, this also became infected and i had yet another surgery and infection. They had to redo the surgery on my right chest instead of my left. The specific company for the vns was made by cyberonics with generator (b)(4). After this surgery i had to stay one night in the hospital. I moved to (b)(6) to be near my sister who helped me out. The trip from (b)(6) is 45 minutes as opposed to 3 hours. On one trip from (b)(6) i totaled my (b)(6), i don't remember why. Some of the leftover symptoms are: i have not worked since 2011 in a job i loved as (b)(6); i have really bad balance and numbness on my left side, i go to the hospital at (b)(6) every 4 months to get a contrast mri with the neurosurgeon and with a neurologist to check and adjust my medication if needed. I cannot use a ladder, cannot swim alone, cannot kayak or canoe with my family, i cannot snowboard with my girls anymore, occasionally i lose my driver's license for medical reasons. So that is my story. One thing to add is that along the way someone snagged and paralyzed one of my vocal cords, it will remain that way for the rest of my life. After all this happened, my eyesight changed, i never had to use eyewear until after all this. Thank you, and if you need anything further, please feel free to call me (b)(6). I am not sure my cognitive abilities will ever be the same. " mfr report #1644487-2016-01151 reports the potential infection from replacement surgery on (b)(6) 2013 per the following portion of the patient's report: "i had yet another surgery and infection".

Event Description
On (b)(6) 2013, it was reported that the vns patient had an infection one month after implant that required explant of the vns. The patient was scheduled for re-implantation of the vns on (b)(6) 2013. The patient underwent re-implant surgery on (b)(6) 2013 and the surgeon placed the leads on her right side due to a previous surgery that caused her right vocal cord to be paralyzed. The surgeon stated that after her previous infection on the left with the original implant, he didn't want to take the chance of damaging her left vocal cord. The previous surgery that caused the right vocal cord paralysis was a cervical fusion done may years ago. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator and lead were sterilized prior to distribution. Good faith attempts for further information from the physician have been unsuccessful.

Manufacturer Narrative
The serial number provided for the generator provided on page 4 of the medwatch received indicated "(b)(4)". This is the generator that was implanted in 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3119822
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dennis100
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« Reply #97 on: October 16, 2017, 12:34:16 AM »

Model Number 102
Event Date 01/01/2013
Event Type Injury
Manufacturer Narrative
Evaluation codes: the initial report inadvertently reported the incorrect conclusion code. There is sufficient information to suggest that the increased seizures is related to normal battery depletion per the physician and is substantiated by the battery life calculation of 0 years remaining.

Event Description
Additional information was received that it is unclear if the patient will move forward with surgery as he is having problem with his prostate. The patient has been continuing to have an increase in seizures and had approximately 15 in a 2 week period. The generator was reported to be depleted.

Event Description
On (b)(6) 2013, it was reported that the patient thinks the vns is not helping but the physician disagrees as the patient¿s seizures are increasing as the ¿device wanes. ¿ clinic notes were previously received dated (b)(4) 2013 which indicated that the patient started experiencing intermittent tingling throughout the body that started 10 days previously. The patient¿s settings were noted to be output= 3. 25ma, magnet output= 3. 5ma, frequency= 20 hz, pulse width= 250usec, on time= 30, off time=1. 8 min. It was stated that the patient¿s battery was dead and the patient would be referred for replacement. The physician later reported that the hypoesthesia was not related to vns. He again reiterated that the patient¿s battery is dead and needs to be replaced. Although surgery is likely, it has not occurred to date. A battery life calculation was performed which showed 0 years remaining until eri=yes. It was later reported on (b)(6) 2013 that the physician has not made any decisions yet as to what he will do. The wife stated that the patient had 2 cps and 1 grand mal seizure within 2 days of each other recently and the wife thinks it¿s because he either missed a medication or because the vns is no longer working. She stated that the battery stopped working about 2-3 months ago. It was reported that the patient is still on hold for surgery and not ready to move forward.

Event Description
An implant card was received indicating that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to battery depletion. Per the implant card, the device could not be interrogated due to end of service. The explanting facility discarded the explanted device; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3229198
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dennis100
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« Reply #98 on: November 13, 2017, 02:58:33 AM »

Model Number 102
Event Type Injury
Event Description
Good faith attempts for additional, relevant information have been unsuccessful to date. The reporter was unable to provide details. She reported she was reporting only off of medical records.

Event Description
Additional information was received from the surgeon that the migration event occurred in relation to events previously reported in mfg report #: 1644487-2013-00218. As a result, this is a duplicate report, and the migration event will be reported on the applicable mfg report #: 1644487-2013-00218.

Manufacturer Narrative

Event Description
It was reported that the patent underwent device replacement due to migration of the device due to weight loss on one occasion. However, the time of the event is unknown. Manufacturer report # 1644487-2011-01472 captured replacement due to tingling and burning around the generator for the patient. Manufacturer report # 1644487-2013-00218 captured explant due to pain related events for the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4555290
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dennis100
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« Reply #99 on: November 16, 2017, 02:52:41 AM »

Model Number 102
Event Date 01/17/2013
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was admitted to the hospital in late (b)(6) 2013 for numbness and tingling in the left arm and hand. X-rays were taken and it was reported that this may have been a side effect of either seizures or vns. It was reported that device diagnostics were within normal limits. The device was programmed off and the symptoms subsided. The device was programmed back on and the patient was discharged. The patient was seen again in (b)(6) 2013 and the device was said to be functioning as intended. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4573216
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dennis100
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« Reply #100 on: November 21, 2017, 02:55:07 AM »

Model Number 102
Event Date 05/20/2015
Event Type Injury
Event Description
Additional notes from patient's visit to the hospital were received. On 5/20/2015, the patient reported that she will usually have 2 stimulations throughout the day, each lasting for approximately 30 seconds. But on (b)(6) 2015, patient reported a feeling of low frequency stimulation and also reports that she had one episode of higher frequency stimulation that lasted for approximately 2 minutes. No history of similar events in the past were reported. Patient denied any other changes to her health including increased seizure activity until (b)(6) 2015. Since patient had the vns implanted, patient's family felt her seizures were shorter in duration. Device diagnostics were completed on (b)(6) 2015 and lead impedance was ok and device was not near end of service.

Event Description
It was reported that the patient experienced dizziness, tingling sensation in the fingers and increased perception of stimulation recently. Patient¿s dizziness and tingling sensation in the fingers were later reported to be possible partial seizures. Patient had gone to the er as she does not have a neurologist and the er nurse was informed about the magnet uses to disable the device. Additional information was received from the er nurse that the patient reported normally feeling stimulation from vns about twice a day. On (b)(6) 2015, the patient felt constant stimulation and experienced neck pain with stimulation. When magnet was taped to temporarily disable the vns, the pain was initially worse and then gone. However this repeated in a pattern where the pain was worse and then gone for a few minutes. Patient visited another hospital and the patient¿s generator was programmed off using the vns programmer. Since disablement of vns on (b)(6) 2015, patient did experience an increase in partial seizures due to loss of therapy. The patient was later seen by a nurse practitioner on (b)(6) 2015 and the vns was turned on to low settings of 0. 5/30/250/30/5/0. 75/60/500. Even at these settings, patient experienced coughing and voice hoarseness with stimulation and therefore medical professional decided to turn device off again and refer patient for vns replacement surgery. Diagnostics were performed and the impedance was within normal limits. The device was not at end of service. Chest x-rays were taken and no obvious issues were found. There was no trauma per patient prior to the events on (b)(6) 2015. Patient¿s previous vns settings prior to the reported events were unknown as the previous neurologist retired. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4840313
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« Reply #101 on: November 21, 2017, 02:56:02 AM »

Model Number MODEL 250
Event Date 05/19/2015
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2015. The explanted generator (pulse gen model 101, sn (b)(4)) was returned to the manufacturer for analysis. Monitoring of the device output signal showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
It was reported that the vns patient was having a tingling sensation in her throat and experienced painful stimulation when a system diagnostic test was performed during an office visit on (b)(6) 2015. It was noted that the system test ¿didn¿t go through. ¿ the device was disabled the next day. The tingling sensation resolved after the device was disabled; however, the patient began twitching more. Review of the available programming and diagnostic history showed that an interrupted system diagnostic test occurred that caused an unintended change in device settings during the office visit. The patient had not been ramped up to an output current of 1ma likely due to tolerability issues. As system diagnostic tests run at an output current of 1ma, it is likely that the painful stimulation and tingling sensation were due to the system diagnostic test. The patient was referred for a surgical consult for further evaluation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4851320
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« Reply #102 on: November 22, 2017, 03:43:35 AM »

Model Number 300-20
Event Date 03/01/2015
Event Type Malfunction
Event Description
It was reported that the patient's device was programmed back on during a recent clinic visit. The physician ran a system diagnostic test, which returned an impedance value within the normal limits. The physician later reported that he did not perform diagnostics in multiple positions during the clinic visit. The physician reported seeing an impedance value that indicated high impedance, but stated that impedance was ok during both system and normal mode diagnostic testing. No additional relevant information has occurred to date. No surgical intervention has occurred to date.

Event Description
It was reported that device diagnostics resulted in high impedance (> 10,000 ohms). It was reported that a second diagnostic test was performed which was within normal limits. A third diagnostic test was performed with the patient's head turned which resulted in another high impedance reading indicating a possible intermittent lead break. The device was programmed off and the patient was referred for surgery. It was reported that the patient suffered a fall against a cabinet on (b)(6) 2015 where the patient hit the cabinet pretty hard. The patient suffered another fall in (b)(6) that resulted in an emergency room visit. It was later reported that the patient wants to hold off on lead replacement surgery since the patient has experienced a dramatic decrease in seizures since (b)(6). The patient wants to wait and see what happens.

Manufacturer Narrative
(b)(4): device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
The patient reported that he no longer felt magnet stimulation during his daily morning swipe when the high impedance was initially identified. The patient also reported experiencing a slight tingling sensation at his generator site. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4812080
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dennis100
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« Reply #103 on: November 22, 2017, 03:44:27 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 06/24/2015
Event Type Injury
Event Description
It was reported that the vns patient¿s device was disabled for mri on (b)(6) 2015. After the mri, the physician attempted to interrogate the patient¿s device, but the patient reported experiencing erratic stimulation from her device when the programming wand was placed near the generator. The patient¿s device was interrogated and found still programmed off. The patient did not experience any erratic stimulation prior to device disablement. The physician programmed the patient¿s device back on to previous settings. The patient also reported having chocking sensations and pain and numbness in her left arm associated with stimulation on-times. It was noted that the patient was mentally delayed, but the physician stated that the patient¿s symptoms did not appear to be psychological. On (b)(6) 2015, the patient returned to the clinic and the patient¿s device magnet mode was disabled. The patient continued to experience erratic stimulation from her device. The patient went to the emergency room on (b)(6) 2015. The patient¿s device was disabled and the issues resolved. X-rays were taken and were reported by the physician to be unremarkable. The patient was evaluated by the surgeon on (b)(6) 2015. The patient¿s device was programmed on and tolerated the programming session well. The patient device was tested and showed normal device function. No further information relevant to the event has been received to date.

Manufacturer Narrative

Manufacturer Narrative
Corrected data: the initial mfr. Report inadvertently reported the event as a malfunction rather than a serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4940403
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« Reply #104 on: November 23, 2017, 02:13:59 AM »

Model Number 102
Event Date 01/01/2013
Event Type Injury
Manufacturer Narrative
Date of event, corrected data: (b)(6) 2013. The event date was inadvertently reported as (b)(6) 2014 in the initial report.

Event Description
It was reported that the patient is undergoing an explant for vns due to experiencing some pain. Additional information was received that the patient's vns was inactive for the last 6 months. Patient experiences radiating pain in her neck. It was later reported that the patient was also diagnosed with pseudo seizures in (b)(6) 2013 based on video eeg. Vns was turned off a month prior to (b)(6) 2013 due to the sensation that it was shocking patient. In (b)(6) 2015, patient reported that she has been having pain with her vns at the implant site, tingling in her neck and can't breathe despite vns being off. Patient's generator was explanted on (b)(6) 2015. The explanted generator has not been received by the manufacturer.

Event Description
The cause of patient's pain, tingling and difficulty breathing while vns is disabled is unclear. The explanted generator is believed to have been discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4887499
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« Reply #105 on: November 25, 2017, 08:47:03 AM »

Model Number 103
Device Problem Battery issue
Event Date 06/01/2015
Event Type Injury
Event Description
The explanted device was discarded after surgery and will not be returned for analysis.

Event Description
It was reported that the patient had a generator replacement on (b)(6) 2015. Information obtained on (b)(6) 2015 that the patient was seen on (b)(6) 2015. It was noted that the patient was last seen in (b)(6) 2014 and seizures were well controlled. However, over the last 3-4 weeks she has noticed more frequent seizures. For most of her seizures, she usually has aura, which was described as tingling sensation in hands, followed by difficulties with getting the words out, lasting about a minute. Over the last 3-4 weeks, she had two episodes of generalized tonic-clonic seizures without any warning. The battery was interrogated and showed that the battery is low with ifi-yes. Over the last few months, she has also been complaining of worsening headache with dizziness spells. Attempts for further relevant information have been made but have been unsuccessful to date. The explant generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5021879
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« Reply #106 on: November 29, 2017, 01:49:03 AM »

Model Number 103
Device Problem Migration of device or device component
Event Date 05/08/2015
Event Type Injury
Event Description
Patient was implanted with vns on (b)(6) 2015. Vns was programmed on on (b)(6) 2015. Initially, the magnet was helping with her seizures. Additional information was received that the patient's vns was removed on (b)(6) 2015. It was removed due to all of patient's symptoms. Patient also had an increase in seizures above her pre-vns baseline and started having convulsions which she did not have prior to vns. Patient never reached therapeutic levels and the device was disabled on (b)(6) 2015. Clinic notes dated (b)(6) 2015 were received indicating that since the patients last visit, patient's vns has shifted down from the original placement spot. Patient has been experiencing painful sensations in the left face and under both sides of her jaw. This spreads down the front of the left side of her neck. Patient describes the pain as pins and needles. This occurs randomly and not just when the vns is stimulation and worsens considerably with magnet mode (higher output current) stimulation. Patient has difficulty with daily activity due to the generator moving around. When the magnet was swiped, significant dystonic pulling of the left face and neck was noted associated with extreme discomfort on the part of the patient. The vns was turned off as a result. Physician's assessment was that the patient's painful facial and neck sensation and dystonic motor movements of the face and neck may represent a spread of electrical current and the entire system should be removed and replaced. Patient visited the hospital on (b)(6) 2015 because of a generalized seizure and an increase in the pain patient also had a convulsion. Noted dated (b)(6) 2015 indicates that the patient's headaches are worse since the increase in vns settings. Patient feels soreness at the vns generator site. It is implanted more medially in the chest wall near the sternum, rather than the axillary area. She feels that her vns has turned and is now vertical. This is pulling on the lead in her neck. Since the surgery, the vns has rotated and dropped inferiorly, placing a weight and stretching burden on the lead attached to the vagal nerve. Patient's normal and magnet mode output current were decreased from 0. 5 ma and 0. 75 ma to 0. 25 ma and 0,5 ma respectively. The explanted products will not be returned to manufacturer unless the patient signs a release form.

Event Description
It was reported that a patient has neuropathy at the lead site. She reported constant pain in the neck, numbness under the chin, and a lead pulling sensation. She also reported that the device has migrated and is experiencing pain from the migration at the chest site. The patient has been referred for surgery. No known surgical interventions have occurred to date.

Manufacturer Narrative
Suspect device udi: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5088394
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« Reply #107 on: December 04, 2017, 01:46:40 AM »

Event Type Injury
Manufacturer Narrative
Event Description
An article titled "vns lead removal or replacement surgical technique, institutional experience and literature overview" was published on (b)(6) 2015 which included adverse events involving 7 vns patients. One patient presented vocal cord paralysis and underwent lead replacement. Two patients presented lead fractures, lack of efficacy and paresthesia and they underwent explant. Two patients presented increased seizures and underwent vns replacement. Two patients suffered small laceration of the internal jugular vein which was repaired with a suture and which occurred during lead explant surgery due to lack of efficacy without replacement of the lead. The manufacturer report # 1644487-2015-05981 involves the patient who presented vocal cord paralysis. The manufacturer report # 1644487-2015-05982 involves the first patient who presented lead fracture, lack of efficacy and paresthesia. The manufacturer report # 1644487-2015-05983 involves the second patient who presented lead fracture, lack of efficacy and paresthesia. The manufacturer report # 1644487-2015-05984 involves the first patient who presented increased seizures and underwent replacement. The manufacturer report # 1644487-2015-05985 involves the second patient who presented increased seizures and underwent replacement. The manufacturer report # 1644487-2015-05986 involves the first patient who suffered small laceration of the internal jugular vein. The manufacturer report # 1644487-2015-05987 involves the second patient who suffered small laceration of the internal jugular vein.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5116364
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« Reply #108 on: December 09, 2017, 02:04:10 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 10/17/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was complaining of sternal pain with stimulation. However, the vns settings were lowered in steps and eventually disabled with no relief. The vns was programmed back on. The patient was referred for prophylactic vns generator replacement. Clinic notes were later received that indicated that the patient's pain was just below the site of his vns generator and was sharp with some mild radiation down the chest. Over the counter pain medication had limited effect and the patient was prescribed a topical lidocaine. Imaging was reviewed by the physician's office, but not the manufacturer, and no gross issues were noted. The patient was then referred for full vns replacement surgery per the clinic notes. The patient underwent only vns generator replacement surgery. The explanted generator was received by the manufacturer and is pending product analysis. It was later reported that the patient was still experiencing pain after the vns generator replacement surgery. The patient reported that for two days postoperatively, there was no pain, but shortly after, the patient began to experience the pain again. The pain was not associated with vns stimulation, but the patient reported that it was a tingling sensation that radiated into his neck. It was noted that the incision from the generator replacement surgery was well healed. There was no indication of damage on the lead during the vns generator replacement surgery. However, the patient is being referred for vns lead replacement surgery to attempt to alleviate the pain. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7030468
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« Reply #109 on: January 07, 2018, 03:26:54 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 06/23/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by the physician and the patient that the patient was referred for explant as the patient experienced a lack of efficacy and the vns wasn't worth the side effects. It was also noted the device was programmed off months ago and the patient did not experience an increase in seizures due to the vns having been programmed off. A battery life calculation was performed on 01/05/2017 and reviewed on 01/10/2017. The in-house programming history database contained information from 07/30/2014 through (b)(6) 2014. No anomalies were noted and the impedance was within normal limits. Based on the information provided, and the parameters/diagnostic history found within the vns therapy programming history database, the patient had approximately 10 years remaining until neos = yes. The programming history database was reviewed on 01/10/2017. The database contained programming history from 07/30/2014 through (b)(6) 2014. No anomalies were noted. The patient was last programmed on (b)(6) 2014. The last diagnostics were performed on (b)(6) 2014 and showed the device was working as intended. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Additional information was later received from the physician's office. It was noted the patient experienced neck flexes and tingling. It was noted the something (the information was illegible) was ineffective in aborting seizures from 2014-2016. It was also noted that the output current had been decreased over 2014 and 2015 due to the reported side effects. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6238631
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« Reply #110 on: February 02, 2018, 03:11:21 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 06/23/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by the physician and the patient that the patient was referred for explant as the patient experienced a lack of efficacy and the vns wasn't worth the side effects. It was also noted the device was programmed off months ago and the patient did not experience an increase in seizures due to the vns having been programmed off. A battery life calculation was performed on 01/05/2017 and reviewed on 01/10/2017. The in-house programming history database contained information from 07/30/2014 through (b)(6) 2014. No anomalies were noted and the impedance was within normal limits. Based on the information provided, and the parameters/diagnostic history found within the vns therapy programming history database, the patient had approximately 10 years remaining until neos = yes. The programming history database was reviewed on 01/10/2017. The database contained programming history from 07/30/2014 through (b)(6) 2014. No anomalies were noted. The patient was last programmed on (b)(6) 2014. The last diagnostics were performed on (b)(6) 2014 and showed the device was working as intended. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Additional information was later received from the physician's office. It was noted the patient experienced neck flexes and tingling. It was noted the something (the information was illegible) was ineffective in aborting seizures from 2014-2016. It was also noted that the output current had been decreased over 2014 and 2015 due to the reported side effects. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6238631
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« Reply #111 on: February 09, 2018, 03:06:25 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 12/29/2017
Event Type Injury
Event Description
It was reported that this patient was doing fine right after vns surgery, but about a week later complained of hoarseness, shortness of breath and was unable to speak. The ent stated that the patient had left vocal cord paralysis and leukoplakia. The left vc paralysis was stated to most likely be secondary to swelling and inflammation around the nerve after the vns was placed since the symptoms occurred 1 week after surgery. The patient was prescribed antibiotics and steroids due to the symptoms. The doctor stated it might take months for vcp to improve. The patient¿s vns device has not been turned on since surgery. It was also stated that this patient is a heavy smoker. The patient did also complain of numbness on the left neck at the neck incision. Additional information was received from the surgeon indicating that the patient's shortness of breath is likely due to left laryngeal weakness, and that the heavy smoking at approximately 1. 5 packs per day contributes to this as well. The vocal changes are due to laryngeal weakness, and the leukoplakia of the larynx is due to smoking. The patient's numbness at the incision site is an anticipated result of a neck incision. No other relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7230517
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« Reply #112 on: February 10, 2018, 02:20:29 AM »

Model Number 302-20
Device Problem Fracture
Event Date 12/05/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that high impedance was detected on the patient's device. The patient was experiencing numbness on the left side of their face and left ear. No known surgical intervention has occurred, to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7171718
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« Reply #113 on: March 10, 2018, 02:41:44 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 08/25/2008
Event Type Injury
Event Description
It was reported that a vns patient would experience shortness of breath with exercise. The device was programmed off however the patient continued to experience shortness of breath and the patient was scheduled to have the device removed. The shortness of breath occurred sporadically and was not related to stimulation on times. Additional information received indicated that the patient suffers from anxiety and that was why the device was explanted. The anxiety is not related to vns and is pre-existing however the physician believed that due to the patient¿s anxiety, she could not handle being implanted with the device. The physician indicated that the shortness of breath could be related to the anxiety but was not sure. Additional information was provided that the device was explanted due to syncope and other complications. The explanting surgeon stated that at the time he noted that it was causing intermittent traction of the vagus nerve. It was noted that the patient also had increased heart rate. Clinic notes dated (b)(6) 2008 (a few months after implantation (b)(6) 2008), it was noted that since vns was implanted, before it was turned on, the patient has complained of shortness of breath and exercise intolerance (this may have been why the patient had increase in heart rate). There was a note that the patient did have exercise induced asthma prior to vns implantation. However, the patient states that it specifically causes problems with her breathing and believes it is all because of the vns. The notes then go on to state that vns was interrogated and settings were 0. 5ma (changed from 30sec on to 60sec). Notes indicated that the physician tested the patient¿s pulse oximetry and pulse before turning the vns on. There were no notable changes and the physician stated that based on the results the physician did not think there was any obvious change both with exertion and at rest whether or not the vns was on. The patient was still quite upset so they elected to turn it off. Notes dated (b)(6) 2009 indicate the device has still been off since (b)(6) 2008 and the patient still has had problems of a sense of pulling in her throat, difficulty breathing, exercise intolerance, syncopal episodes, left facial numbness, all of which she reports are intermittent. She can reproduce some of these problems when she turns her head to the right for prolonged periods of time or when she pushes upon the sternomastoid muscle a few cm from the incision. This would be at the location of the lead itself. The surgeon assessed the patient and attributed that there is excessive traction on the nerve with turning of her head and most of not all of her other symptoms are likely related to intermittent traction on the vagus nerve. Surgeon offered surgical intervention to possibly increase the size of the strain relief loop in an attempt to ameliorate the traction that she suspects caused these issues. He also offered a more extensive option to remove the vns if she preferred. The patient decided to remove the device entirely on (b)(6) 2009. The entire system was removed including all 3 helical coils. Notes dated (b)(6) 2009 did state that the patient has had none of the symptoms she had previously. No additional or relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7237189
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« Reply #114 on: March 10, 2018, 02:42:31 AM »

Model Number 302-20
Device Problem Fracture
Event Date 01/04/2018
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing a tingling sensation at the electrodes that traveled from her ear to her head. Diagnostics were performed after the tingling started, and high impedance was present. The patient used the magnet to disable the device, and she planned on asking her physician to program it off. No surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7262565
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« Reply #115 on: March 19, 2018, 02:05:23 AM »

Model Number 302-20
Event Date 03/01/2012
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2012, the clinical specialist reported that she reviewed the patient's chest and neck x-ray report and they were abnormal with a possible disruption of the lead in the left neck. The physician recommended that a soft tissue neck report be performed. The neos flag was no for diagnostics and results of both the normal mode and system diagnostics were within normal limits. The soft tissue neck report indicated that the lead was intact. It was noted that each time diagnostics were performed, the system diagnostic's dcdc=3 and the normal mode dcdc=2 consistently. The patient has been experiencing shortness of breath within the last 6 months - 1 year and has had pain that runs down her arm and numbness when firing that also runs down her arm. There is no increase in coughing and the seizures are still monthly. The nurse practitioner had said that they ruled out cardiovascular and pulmonary issues with the shortness of breath. A battery life calculation was performed which showed 6. 37 years remaining until eri=yes. A/p and lateral x-ray images of the neck dated (b)(6) 2012 were received by the manufacturer. The generator was not able to be visualized due to the views in the x-rays provided. Therefore, whether or not the lead pin was fully inserted into the header of the generator could not be assessed. The electrode placement appeared to be normal and no lead discontinuities or acute angles were seen in the visible portions of the lead body. The patient later reported on (b)(6) 2012 that the device is causing her pain on and off throughout the day for about 5-6 plus hours a day. The patient was asked to be seen again regarding an evaluation of medications and vns. Good faith attempts for further information from the physician have been made but have been unsuccessful.

Event Description
On (b)(4) 2012, additional x-ray images were received, however these were the same x-ray images that had been provided by the physician earlier.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2794888
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« Reply #116 on: April 23, 2018, 01:06:47 AM »

Event Date 01/01/2012
Event Type  Injury   
Manufacturer Narrative
Garci´a-navarrete e, et al. Long-term results of vagal nerve stimulation for adults with medication-resistant epilepsy who have been on unchanged antiepileptic medication. Seizure: eur j epilepsy (2012), http://dx. Doi. Org/10. 1016/ j. Seizure. 2012. 09. 008.
 
Event Description
An article entitled ¿long-term results of vagal nerve stimulation for adults with medication-resistance epilepsy who have been on unchanged antiepileptic medication¿ was received. Forty-three patients were followed. After implant, patients were evaluated on a monthly basis increasing stimulation 0. 25 ma at each visit, up to 2. 5 ma. Medication was unchanged for at least 18 months since the stimulation was started. Of the 43 operated patients, 63% had a simulation or great than 50% reduction in seizure frequency. Differences in the responder rate according to stimulation intensity, age at onset of epilepsy, duration of epilepsy before surgery, previously epilepsy surgery, and seizure type, did not reach statistical significations. Most side effects were well tolerated. One patient reported an increase in the duration and intensity of his seizures. Twenty-two patients experienced side-effects. The most common were mild, consisting in hoarseness, neck tingling or occasional coughing at the time when the signal was on, all of which were usually well tolerated. Two patients had intermittent dyspnea, and another patient experienced occasional episodes of dysphagia with stimulation. Irritability was reported by two families, in the context of a general improvement in the level of alertness. Five had severe side effects, requiring their vns generators to be inactivated or explanted. Three of the 5 patients that stopped receiving stimulation had been responders. Reasons for explanation were infection in two patients, and odynophagia, in one patient. One patient had an exacerbation of a previous behavior disturbance, with severe aggressiveness, which improved when the stimulator was inactivated. Seizure reduction was maintained after the stimulation was stopped. Another stimulator was removed at family request, owing to a persistent abdominal pain. One explant due to infection is captured in this report: mfr report# 1644487-2013-01450. The other explant due to infection is captured in mfr report #1644487-2013-01453. The explant due to odynophagia is captured in mfr report #1644487-2013-01449. The explant due to abdominal pain is captured in mfr report #1644487-2013-01447. The report of increased seizure duration and intensity is captured in mfr report #1644487-2013-01444.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3120504
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« Reply #117 on: May 05, 2018, 12:18:39 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 10/07/2011
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was experiencing pain in the chest area that goes down her arm, neck pain, tingling sensation in their arms, headaches, back pain, right shoulder pain, and paraesthesia in the upper and lower extremities. Due to the pain, it was also reported that the patient was experiencing sleep disturbances. Device diagnostics were performed and reported to be normal limits. Per the physician's assessment, the cause of the events is due to the surgeon nicking the nerve during surgery. The patient was referred for surgery due to the pain. No additional relevant information has been received to date. No surgical intervention is know to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7445025
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« Reply #118 on: May 22, 2018, 02:31:57 AM »

Model Number 302-20
Event Date 01/19/2013
Event Type  Injury   
Event Description
On (b)(4) 2013 a referral was received for replacement of the vns due to it ¿failing¿. It was stated that the vns had been turned off the psychiatrist due to severe pain on the vagus nerve. It was reported that the patient has a possible lead fracture.
 
Event Description
On (b)(6) 2013 the patient mentioned that she had a device malfunction in january and subsequent device disablement since the event. The nurse later reported that the vns patient had a device failure because the patient developed severe pain/discomfort at the electrode site. It was stated that diagnostics were performed that indicated the device is not near end of service and that the lead impedance was ¿ok. ¿ the nurse stated that she feels that there is an issue with the lead despite the diagnostic results due to the patient¿s clinical symptoms. X-rays were also reported to have been taken, which didn¿t show anything. The device was disabled temporarily and it did get better about two weeks after the device was disabled. She stated that diagnostics were even taken with the patient in different positions and while the device functioned properly during all of these tests, she still believes that there is an issue that is causing the patient¿s events. The patient was referred to the surgeon for revision. Although surgery is likely, it has not occurred to date. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Event Description
On (b)(6) 2013 the nurse practitioner reported that over the past weekend the patient started feeling pain in her neck at the lead site that radiates up to her jaw and neck and down her left arm and left leg. The patient stats that the pain is with stimulation but she feels a soreness in the area all of the time. The patient denies any trauma but the patient is raising a child that can sometimes be combative and has hit her in the head but she doesn't remember anything specific at the time she felt the pain. The patient's settings were output = 1. 75 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. The patient was programmed off to output = 0 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. She states the patient said the pain went away but she was still feeling the soreness. She states before she turned the patient off she did system diagnostics and all was ok with dcdc of 2 and neos = no. She is not sure at this point where she will proceed from here. The manufacturer's consultant later stated that he spoke with the patient on (b)(6) 2013 and she reported to him that on (b)(6) 2013 that she was having heart palpitations, along with nausea and vomiting that she thought was the onset of a migraine. Later the patient wasn't still "feeling right" so she decided to disable the device for the rest of the night. In the morning on 01/20/2013, the patient removed her magnet and she then started vomiting. She was also having tingling and numbness on her left side, so she again disabled the device with her magnet, which resolved the issues. The patient also noted that since this weekend, she was also feeling tightness where the electrodes are located and a lead pulling sensation in her neck when she uses her right arm to blow dry her hair. She said that she typically doesn't feel stimulation with the on-times, but does get voice alteration during the stimulation. The patient noted that she has a (b)(6) daughter that does like to jump on her. The patient is also getting efficacy from the therapy and is fearful that she is going to get worse because the nurse disabled the device on (b)(6) 2013. The patient's nurse practitioner indicated that the patient was implanted for treatment resistant depression in 2006 but also has a diagnosis of schizophrenia. The nurse stated that she recently had to turn the patient's device to zero as the patient began having pain in lead/generator area that radiated up to her jaw and down her left arm and leg. She stated all diagnostics were normal. The patient was going to be seen for follow-up on (b)(6) 2013 and the nurse has decided to keep the device turned off until that day. The patient is also considering meeting with her primary care physician to have her throat evaluated due to the feeling in her throat. The patient later indicated on (b)(6) 2013 that the constriction feeling in her neck was continuing to increase the previous night and the numbness in her extremities was disturbing, with an intolerable migraine type headache in forehead area with significant pressure at the base of the back of her head. She said the physician seems to think initial irritation of the vagus nerve is possibly consistent with the intermittent issues he has seen with devices nearing end of battery life. X-rays were taken and a ct with no visual concern. The diagnosis was painful neuropathy and migraine. The patient was given iv fluids, steroids to reduce inflammation, iv phenergan, and a prescription of neurontin. The patient stated that on (b)(6) 2013 there is less constriction in the neck, the migraine persists, and neuropathic pain. The patient stated that the discomfort is more tolerable without the constricting feeling in the neck. On (b)(6) 2013 the manufacturer's consultant stated that he met with the patient and the nurse practitioner that day and the patient has been through a lot of psychological issues. He started with a summary of the events saying that on (b)(6) 2013 the patient's symptoms got so bad (constriction in her neck), that she had to go to the emergency room and at that time felt a tingling in her extremities and pain in her left arm and up to the electrodes in her neck. The emergency room doctor said he had never seen anyone with vns but has seen patients with other similar devices and thought maybe vns caused damage to the nerve. Therefore, he gave her steroids to treat nerve pain. With these iv steroids all the events went away. Now the patient's symptoms are completely gone and the device is disabled. The patient also reported that the week of (b)(6) 2013 she lost her voice; she had virtually no voice and said it was as if the stimulation was on all of the time based on her losing her voice. As of today, the patient's depression is still better than pre-vns levels but the patient is starting to get anxious that the vns is not on. The consultant stated he will get x-rays and the emergency room report and will send that to the manufacturer for review. The nurse practitioner stated that with the device being disabled, all the events resolved except for the neuropathic pain and tingling in the extremities/discomfort. It was reported that it was thought that the emergency room diagnosed the event as neuropathic pain to get insurance to pay for it but the patient is not having any events now. The nurse practitioner believes that all of the patient's events are due to vns. She did report however, that the heart palpitations, tingling, numbness, and vomiting/nausea are not occurring with stimulation. No causal or contributory programming or medication changes precede the onset of the events. The patient does not have a medical history of any of these events (pre-vns). The patient's device was disabled but since the patient is desperate to have vns working, they want to have a full revision surgery as they believe the vns is causing the patient's symptoms. On (b)(6) 2013 the device was programmed back on to output = 1 ma/frequency = 500 usec/on time = 30 sec to run system and normal mode diagnostics; which were within normal limits. The system diagnostics showed dcdc = 3/eri = no and normal mode showed dcdc = 2/eri = no. The patient was then disabled again. Although surgery is likely, it has not occurred to date.
 
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient recently had her device turned off on (b)(6) 2013 due to pain in the neck. This pain started on (b)(6) 2013 and the patient had disabled the device herself by using her magnet which helped. The patient also started vomiting when she removed the magnet. The reporter also explained that when the patient uses her right arm to blow-dry her hair, she feels a tightening feeling around the electrodes in the left side of her neck. She explained that she was seen in the er and the er physician informed her that she is experiencing irritation to the vagus nerve which he has seen previously when other implanted devices were nearing the end of their service life. She stated that x-rays had been taken and she was placed on iv fluids as well as steroids to help with the adverse events she was experiencing. The patient was anxious about what may happen as far as her depression since the nurse practitioner had turned off her device. Since the device has been off the patient has felt a lot of anxiety and is not sleeping hardly at all; she stated that it is like "time has no meaning". The reporter also mentioned that she had seizures prior to implant which stopped after being implanted. It was later reported that the patient's device appeared to be functioning normally when queried but she had significant discomfort and developed neuropathy. She was treated with steroids and neurontin for that and it resolved. Clinic notes were received. Review of the notes dated (b)(6) 2013 state that this was an emergency session to adjust the vns settings due to palpitations and discomfort. The patient had pain in left side of jaw with radiation down left arm that had worsened since that weekend. The pain was reported to be intolerable. The patient felt discomfort all down the left side and since the vns was turned off with the magnet she felt better. The patient was anxious and mildly paranoid. Diagnostics showed the device to be functioning properly. Clinic notes dated (b)(6) 2013 indicate that the patient was being treated for neuropathy in the neck and is feeling better physically. Clinic notes dated (b)(6) 2013 indicate that the patient's device is now "failing" and is trying to get a replacement. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Event Description
Generator analysis was approved on (b)(4) 2014. The generator was returned with output currents set to 0 ma. Analysis showed that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. 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. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.
 
Event Description
Information was received that the patient was scheduled for a generator replacement on (b)(6) 2013. Three diagnostics were performed, which confirmed that there were no issues with the lead, so the lead would not be replaced. It was later confirmed that the replacement surgery took place on this day. The explanted generator was returned to the manufacturer on (b)(4) 2013.
 
Event Description
On (b)(6) 2013 it was reported that the patient¿s illness is rapidly progressing as she waits for surgery. Although surgery is likely, it has not occurred to date.
 
Event Description
It was reported that the patient developed neuropathy on the left side of her neck and that her discomfort was severe. It was reported that the device was programmed off and the patient required treatment with steroids to resolve the pain. The nurse reported that x-rays were not helpful in identifying the problem. The nurse indicated that there was no high impedance and the device is not at end of service. The nurse reported that the patient experienced successful response to vns when the device was programmed on and that attempts to have the surgery performed are underway.
 
Event Description
It was reported that the patient was seen for a consult appointment to have the vns generator removed. The patient states that she is afraid of having it replaced and then having difficulty getting it replaced again in the future. However, the physician believes the patient should still stay implanted for now as he wants the patient to get a new generator and believes having a separate explant surgery would cause too much scarring. Additional follow up found that the patient saw the neurologist and everything was within normal limits (specifics not provided). It was noted that the patient's device was disabled and the patient complained of pain when interrogation, but physician said it was only during interrogation and he didn't think it was the device. The patient was referred back to the epilepsy center for epilepsy evaluation. It was unclear if the diagnostics were actually performed and if the patient may have felt pain during the diagnostic.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2966248
« Last Edit: September 01, 2018, 10:21:34 PM by dennis100 » Logged
dennis100
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« Reply #119 on: June 08, 2018, 03:16:26 AM »

Device Problem No Known Device Problem
Event Date 05/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was admitted to the hospital for increased seizures and one episode of status, which was not normal for patient. The patient also experiences a tingly feeling in their neck. Patient's generator could not be interrogated at the time of report. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7542540

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