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dennis100
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« on: February 15, 2018, 02:36:41 AM »

Model Number 103
Event Date 03/19/2013
Event Type Malfunction
Event Description
It was reported that a patient presented with history of chest pain radiating to left arm, with shortness of breath since four months. After the sixth titration, on (b)(6) 2013, the patient had loss of appetite and difficulty in eating due to burning pain while eating. The patient also feels nauseous after eating. This resulted in less intake of food and loss of weight and weakness. The patient has lost about 7 kg of weight and has giddiness. In view of this, the amplitude and duration of the titration were decreased. The subject is under observation and the outcome of the event is considered not resolved. As per the opinion of the private investigator (based on the patient not having these symptoms prior to the sixth titration), the event is not related to implantation and definitely related to stimulation. The patient was admitted for infection and loss of weight on (b)(6) 2013. Upon investigation, it was determined that the patient had dengue fever, which was not related to vns. The infection was similarly not related to vns. The patient was managed conservatively and was discharged on (b)(6) 2013. Additional information was received that concomitant medications and heart failure could not be a cause of the loss of appetite, difficulty in eating, nausea, or weight loss. The loss of appetite and nausea were not due to psychological reasons. The difficulty in eating due to burning pain while eating is the cause for the poor intake of food. As the weight loss was marked related to stimulation, the difficulty in eating due to burning pain while eating and feeling nauseated after eating are related to implantation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3414002
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dennis100
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« Reply #1 on: February 15, 2018, 02:37:23 AM »

Model Number 102
Event Date 01/01/2006
Event Type Injury
Event Description
The pt reported that she had lost 18 pounds in last month or so and was still losing, had no appetite and had to force food down. She additionally reported that she had been receiving ect treatments because her depression was "so bad. " reported "i felt pretty good for a couple of weeks, but as soon as my period arrived, it all went downhill. I'm, perimenopausal and am on hormone therapy. I'm working with my ob/gyn to adjust them, as now i'm having about 2 periods a month - and like clockwork as soon as they hit, i go downhill into serious depression. So i'm averaging about 1 good week per month. " the pt's treating physician did not know if the pt's weight loss was vns related and possibly related to the pt's depression. The pt reported that they were thinking of getting the vns taken out due to throat tightness with stimulation and lack of efficacy, no malfunction suspected. The treating physician did not think that pt was a good candidate for vns therapy. Good faith attempts will be made for product return for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1199909
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dennis100
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« Reply #2 on: February 15, 2018, 02:38:20 AM »

Model Number 104
Event Date 10/17/2012
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2012, it was reported that the patient recently underwent a battery replacement on (b)(6) 2012 and the device was turned on in the operating room. Since the replacement surgery the patient was admitted to the hospital on (b)(6) 2012 due to nausea and vomiting. On (b)(6) 2012, the patient had started coughing and the mother stopped the stimulation with the magnet and took the patient to see his physician who decreased his settings and the coughing stopped. The son then started having dizziness and a blood test at that time revealed that the patient's ammonia level was high. One of the patient's seizure medications was tapered down at that point. During that time, the patient stopped eating and had decreased appetite. On (b)(6) 2012, the patient started having nausea and vomiting. The patient's mother was unsure if it occurred during stimulation or not. On (b)(6) 2012, the patient was taken to the emergency room due to the vomiting not stopping. Blood tests in the emergency room revealed that the patient's ammonia level was okay but the potassium level was low. During this time, the patient's dizziness had persisted according to the mother. The patient was sent home that same day and was still nauseated. The reporter stated that the physician believed that the patient had a distended bladder. On (b)(6) 2012, the patient was taken to the emergency room again and was given medications to help with the nausea and vomiting and was sent home. On (b)(6) 2012, the patient began experiencing severe dizziness and vomiting. The patient was taken to the hospital on (b)(6) 2012 and was admitted to the hospital. On (b)(6) 2012, the device was temporarily disabled until monday, (b)(6) 2012 to see if there is any improvement in the patient's condition. The reporter stated that the patient was still in the hospital on (b)(6) 2012 and the physicians have diagnosed the patient with a bladder disorder and don't seem to think there is an actual problem. The reporter also mentioned that the physicians have also explained that the patient has slow bowel movements which may be contributing to nausea, vomiting, and the eating disorder the patient was experiencing. It was later reported on (b)(6) 2012, the physicians haven't been able to identify the recent cause of the vomiting and other issues since the recent tests were "negative", so the patient may be readmitted to the hospital soon. The patient's settings have been decreased to half of what they were on date of implant, but it was still unclear if the issues had been resolved with this change. The patient had his device programmed off, and is still experiencing the events. On (b)(6) 2012 a physician at the hospital reported that he did not have enough information to know if the patient's events were related to vns as he is not too familiar with the patient. The patient's neurologist wondered if there could be anything leaking from the vns generator that could cause the nausea and vomiting resulting in weight loss the patient has been experiencing. The neurologist stated that she doubts that the device is leaking but that she doesn't know what is causing the patient's issues. The neurologist stated that the patient's nausea, vomiting, and dizziness are not associated with stimulation. She stated that they disabled the vns but the symptoms persisted. No causal or contributory programming or medication changes preceded the onset of the events. The patient does not have a medical history of nausea and vomiting prior to vns but does have a history of decreased appetite prior to vns.

Event Description
The patient's mother reported that the patient had a 51 day hospitalization for nausea and vomiting in (b)(6) 2012 that was ultimately found to be due to a reaction from two seizure medications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2917858
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dennis100
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« Reply #3 on: February 15, 2018, 02:39:14 AM »

Model Number 103
Event Date 09/27/2011
Event Type Injury
Event Description
It was reported that a patient implanted in (b)(6) 2011 was experiencing an increase in seizures in number and intensity since device implant. The patient had about 2 grand mal seizures recently which did not routinely occur prior to implant. The patient has not been sleeping, not eating, and has lost (b)(6) since implant. The device has been programmed on and the physician has begun to titrate the patient's settings. Good faith attempts to obtain additional information will be made.

Event Description
Additional information was received on (b)(6) 2011 where it was reported that the physician did not believe any of the events (weight loss, seizures, sleep disturbances, or loss of appetite) were related to vns therapy or surgery as the device was not programmed on at the time the events occurred. Per the physician, the patient was taking adhd which caused all the events. Once the physician lowered the dosage of the adhd, the symptoms resolved. The device is now programmed on and has been titrated twice without any issues. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2342095
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dennis100
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« Reply #4 on: February 15, 2018, 02:39:54 AM »

Model Number 304-20
Event Date 06/01/2010
Event Type Injury
Event Description
It was reported that a vns patient experienced a loss in appetite and vomiting after eating. The event began after recent full revision surgery that occurred on (b)(6)2010, but not until the device was programmed on. The event has been occurring since the device was programmed on by the md. There has been a medication change, which was a decrease in keppra as it was no longer needed after the vns device was programmed back on. The patient's device was programmed off by the treating neurologist for about a week and programmed back on. The events of vomiting and weight loss did not resolve when the device was off. Moreover, an examination was made by an ent and found the patient's esophagus to be inflamed due to unknown reason. Additional information was received from the ent physician indicating the patient was scheduled to undergo an endoscopy. Furthermore, follow-up was made with the ent which revealed there was no problem or issues visualized with the endoscopy. Biopsy samples were taken and results were normal. However, the ent did find a lot of secretion in the stomach. No stomach bleeding was observed other than the biopsy samples which is normal since the skin is being pierced. At this time, the ent could not assess the event of relationship to vns as he was waiting on a gastric emptying test. Good faith attempts to the treating neurologist at this time have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1851110
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dennis100
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« Reply #5 on: February 15, 2018, 02:40:59 AM »

Model Number 102
Device Problem No Information
Event Date 03/31/2014
Event Type Injury
Manufacturer Narrative
Corrected data: new information received that the suspect device information is unknown.

Event Description
Additional information was received stating that the vns study patient did not continue with the study as the loss of appetite and weight loss had not resolved.

Event Description
It was reported that the serial number of the generator is unknown and the serial number previously provided belonged to the lead, not the generator.

Event Description
Further information was received indicating that the loss of weight had resolved. The event stopped on (b)(6) 2014. The patient recovered.

Manufacturer Narrative
Corrected data: this date was inadvertently left off of follow-up mfr. Report #01. The date should have been reported as 07/10/2014. Follow-up mfr. Report #01 was not a late submission.

Event Description
It was reported that the patient experienced a loss of appetite and weight loss. The device was programmed off as a result. It was reported that the events were probably related to device surgery and possibly related to device stimulation. The events were noted to be ongoing. It was noted that the device was disabled at the patient's request and that evaluation would be performed on whether the device would be programmed back on or if is dropped completely. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3886929
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dennis100
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« Reply #6 on: February 15, 2018, 02:41:44 AM »

Event Date 09/05/2014
Event Type Injury
Event Description
An article titled ¿vagus nerve stimulation therapy in a developing country: a long term follow up study and cost utility analysis¿ was received which included the vns patient adverse events. Two patients experienced post-operative infections that were treated with iv antibiotics, one of which required device explant. One patient had wound dehiscence one week following surgery that was surgically treated. One patient had to undergo surgery to reposition the device due to protrusion. One patient underwent surgery due to a lead issue. Five patients were noted to have experienced significant weight loss due to decrease in appetite. Analgesics did not improve oral intake in the noncommunicative patients, and in one patient decreasing the stimulation intensity did help. Two patients were non-responders but experienced significant weight loss that required either device removal or disablement. This manufacturer report involves the patient who experienced significant weight loss that required decrease in device settings.

Manufacturer Narrative
Vagus nerve stimulation therapy in a developing country: a long term follow up study and cost utility analysis. Aburahma, samah k. Et al. Seizure - european journal of epilepsy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377708
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dennis100
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« Reply #7 on: March 22, 2018, 12:43:38 AM »

Model Number 103
Event Date 08/20/2012
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received on (b)(4) 2013 when it was reported that the patient had a follow-up visit with her nurse practitioner that day. The first interrogation of the device indicated that the device was "off, the output current was 0. 0ma, however the magnet output current was at 0. 25ma. The vomiting has "slowed up some" since (b)(6) 2012 and the patient has lost 40 pounds and has little appetite. There were 3,746 magnet activations captured on the device. The device was then programmed "on" to output=0. 25ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=0. 5ma/magnet pulse width=500usec/magnet on time=60sec. System diagnostics were "ok" and the ohms was noted to be 3,580ohms.

Event Description
It was reported that shortly after the patient's vns stimulation was enabled immediately following initial vns implant surgery, the patient began vomiting. The physician indicated that he was unsure if the vomiting was occurring with stimulation, but he indicated it was likely. The patient was noted as not vomiting when the family swipes the magnet over the generator to activate extra stimulation to abort a seizure. The patient's family believes the patient is having a sensation in his stomach however the patient is nonverbal. The patient's vns was disabled for 3-4 days however when the stimulation was re-enabled, the patient was vomiting so much he became dehydrated and had an increase in seizures requiring hospitalization as a result. Vns diagnostics had not been run since surgery which were noted as within normal limits at that time. The patient's vns has been turned back off for the time being. Follow-up with the patient's neurologist found the patient has a dental abscess which she and the surgeon believe may be contributing to the vomiting with stimulation. They have asked the patient to have resolved and then they will resume vns stimulation. No medication changes were believed to have caused or contributed to the events. Attempts for the missing product information are in progress.

Event Description
Additional information was received on (b)(6) 2013 when it was reported that the vns patient has lost 40 pounds and is vomiting. The patient's device was shut off except for the magnet settings. The physician questioned whether the leads could possibly be placed upside down. The patient was stated to have profuse vomiting when the device is on. It was reported that the patient's device has sporadically been on and off based on the patient's vomiting events. Currently the physician is thinking about turning the magnet mode off as well.

Event Description
Additional information was received on (b)(6) 2013, when it was reported that the patient had the vns device turned off over a month ago by the surgeon because of vomiting. There are no plans to turn it on until the patient sees a gastro physician.

Event Description
It was again reported that since his vns implant, the patient has had serious stomach issues and has lost a considerable amount of weight. The patient, however, has had an improvement in seizure reduction. The patient was noted to have had persistent vomiting, changes in appetite, and weight loss.

Event Description
On (b)(6) 2012, the physician's office reported that they did have any additional information on this patient at this time.

Manufacturer Narrative
Describe event or problem; corrected data: inadvertently stated "on (b)(6) 2012, the physician's office reported that they did have any additional information on this patient at this time" instead of "on (b)(6) 2012, the physician's office reported that they did not have any additional information on this patient at this time" on supplemental report #1.

Event Description
On (b)(6) 2012, the physician's office reported that they did not have any additional information on this patient at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2766219
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dennis100
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« Reply #8 on: April 12, 2018, 12:31:19 AM »

Model Number 302
Event Date 07/02/2015
Event Type  Malfunction   
Event Description
During review of the in-house programming/diagnostic history database, it was observed that high impedance was observed at office visit on (b)(6) 2015. It is unknown if any patient manipulation or trauma occurred that could have caused or contributed to the high impedance reading. Further follow-up found that the patient had been referred for generator replacement surgery. At the time, the surgeon did not want to replace the lead because he was concerned that there may not be enough room on the nerve for a new lead. However it is unclear how the surgeon made this assessment. The generator was replaced on (b)(6) 2015 and the existing lead was connected to the new generator. Following generator replacement a system diagnostic test observed high lead impedance with the newly implanted generator. Programming history indicated that as of (b)(6) 2016 the high impedance had not resolved. The physician was notified of the high lead impedance and the manufacturer's recommendations for addressing high lead impedance events. It was then reported that since the high impedance was observed the non-verbal patient has been agitated and experiencing dysphagia, loss of appetite and trouble sleeping. The device was programmed off on (b)(6) 2016. Following device disablement the patient's behavior and symptoms improved however the patient was still not eating well and appeared to be fearful of food. Attempts to obtain additional information have been unsuccessful to date. It is not known if the lead has been replaced to date.
 
Event Description
The patient's mother provided an update on her daughter's condition since the device was disabled. She reported that prior to the device being disabled she had taped the magnet over the generator and the patient's behavioral issues improved. However when the mother went to place the magnet she accidentally swiped the magnet and activated a magnet stimulation. The patient reacted to "defend herself" and appeared to be in pain from the magnet swipe. She also reported that the patient had undergone a barium swallow test in (b)(6) 2016 which showed that the patient was suffering from muscle spasms. She was placed on prevacid in response to the muscle spasms. However since the vns device has been disabled the patient is no longer suffering from issues with swallowing. The patient is still exhibiting an aversion for eating however the mother believes this may be a defensive response from the previous issues that were caused with the high impedance. The patient had been previously placed on 4 different sleep medications however none of them improved her sleeping difficulties. The patient is still suffering from issues sleeping since the device has been disabled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5972991
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dennis100
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« Reply #9 on: April 12, 2018, 12:31:54 AM »

Event Date 04/26/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was recently hospitalized with aspiration pneumonia. The physician's assistant reported that she wanted to have the device programmed off. It was also reported that the patient's family reported that the patient had difficulty swallowing. The physician indicated that the patient's difficulty swallowing was first observed on (b)(6) 2013 and that the aspiration pneumonia was first observed on (b)(6) 2013. The physician indicated that the patient's parents claim that they have noted a decrease in the patient's appetite since vns implant on (b)(6) 2011. The physician reported that the device was programmed off on (b)(6) 2013 and that the difficulty swallowing has continued; therefore the difficulty swallowing and aspiration pneumonia were not related to device stimulation. The physician noted that there were no causal or contributory programming or medication changes that preceded the onset of the difficulty swallowing or aspiration pneumonia. The physician reported that the patient did not have a history of difficulty swallowing or aspiration pneumonia pre-vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3124944
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dennis100
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« Reply #10 on: April 12, 2018, 12:32:33 AM »

Model Number 102
Event Date 02/18/2011
Event Type  Injury   
Event Description
Analysis of the returned generator was completed. The generator could not be interrogated at two orientations, but was successfully interrogated once the programming wand was repositioned. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Monitoring of the device output current showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. There were no anomalies found with the pulse generator. The generator performed according to functional specifications.
 
Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to battery depletion. The explanted generator has been returned to the manufacturer where analysis is currently underway.
 
Event Description
It was reported by a vns patient that she was having painful stimulation in her neck and chest since her stress test on (b)(6) 2011. The patient said she was also having a loss of appetite with headaches during the stimulation. She alleged that her device was failing. However, her psychiatrist performed system and normal diagnostics which showed the device was within normal limits, dcdc=2, eos=no and dcdc=5, eos=no, respectively. The patient's current settings were 2/20/500/30/5; however, the doctor decreased the output current to 1. 75 ma. The psychiatrist did not want to disable the device because the patient was receiving efficacy. She called manufacturer again on (b)(6) 2011 and stated that her device was failing. She wanted her device removed. She was told to contact her physician; however, she stated that the physician will no longer see her and threatened to commit suicide over the phone. She was offered to be transferred to crisis help line or call 911 which she declined. Manufacturer contacted the treating physician and he stated that patient has had suicidal ideations before but has never followed through. The treating psychiatrist stated that patient's depression and threats of self harm had increased over the last month. The physician didn't feel the patient's issues were related to the vns therapy or the result of a malfunction, just that her disease condition was so severe that it didn't respond to the vns therapy.
 
Event Description
Additional information was received stating that the vns patient had not felt stimulation from her device for quite some time and wants to have the device replaced or removed. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
Additional information was received on (b)(6) 2012, when it was reported that the patient would like to have her vns tested. The patient was dismissed by her last physician and none of the other physicians were willing to see her. The patient was given contact information for additional physicians in her area.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2055651
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dennis100
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« Reply #11 on: April 12, 2018, 12:33:06 AM »

Event Type  Injury   
Manufacturer Narrative
Vagus nerve stimulation therapy in a developing country: a long term follow up study and cost utility analysis. Aburahma, samah k. Et al. Seizure - european journal of epilepsy.
 
Event Description
An article titled ¿vagus nerve stimulation therapy in a developing country: a long term follow up study and cost utility analysis¿ was received which included the vns patient adverse events. Two patients experienced post-operative infections that were treated with iv antibiotics, one of which required device explant. One patient had wound dehiscence one week following surgery that was surgically treated. One patient had to undergo surgery to reposition the device due to protrusion. One patient underwent surgery due to a lead issue. Five patients were noted to have experienced significant weight loss due to decrease in appetite. Analgesics did not improve oral intake in the noncommunicative patients, and in one patient decreasing the stimulation intensity did help. Two patients were non-responders but experienced significant weight loss that required either device removal or disablement. This manufacturer report involves the device protrusion which required surgery to reposition the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377788
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dennis100
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« Reply #12 on: April 12, 2018, 12:33:45 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 01/01/2015
Event Type  Injury   
Event Description
The patient received a prophylactic generator replacement on (b)(6) 2015. Pre-operative system diagnostic results were within normal limits.
 
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2015 note that the patient's depression has been worsening and that the vns battery is out. The patient has been experiencing sad mood, poor energy, poor sleep, decreased appetite, low self esteem, feeling of hopelessness and anhedonia. It is unknown whether or not the depression is an increase above the patient's pre-vns baseline frequency. The patient was referred for surgery. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4661934
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« Reply #13 on: April 12, 2018, 12:34:27 AM »

Model Number 302-20
Event Date 04/10/2014
Event Type  Malfunction   
Event Description
The explanted generator is not available to return to the manufacturer for analysis.
 
Event Description
It was reported that the patient has had multiple issues including pain and decreased appetite since the lead was repaired with silicone. The pain in the neck area was intense, and the patient kept ice applied and took medication as a result. The patient had lead replacement surgery on (b)(6) 2014. The patient reported on (b)(6) 2014 improved adverse symptoms and feeling much better since the surgery. The explanted lead is not being returned to the manufacturer for analysis.
 
Event Description
It was reported that the patient was going to be evaluated by another surgeon for a second opinion. The patient was referred for generator and lead replacement surgery. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Manufacturing device history records were reviewed. Review of the lead device history records confirmed all quality tests were passed prior to distribution.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014, the surgeon repaired two large tears in the lead with silicone. Since the surgery, the patient was having difficulty turning her neck. When she turned her neck, the patient became nauseous from pain in her throat. The patient was unable to eat due to the nausea and had lost weight. The patient was also experiencing tinnitus with her head turned and having daily headaches. The patient¿s device was recently programmed on. The patient previously had a surgical consult on (b)(6) 2013 for a possible lead migration. The surgeon determined there was no lead migration and stated that the patient¿s device was working well. Diagnostic results showed normal device function as of (b)(6) 2013. Review of the available programming and diagnostic history showed normal diagnostic results through 11/23/2011. No known interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
An implant card was received indicating that the vns patient was experiencing spasms and pain at the generator and lead sites prior to generator replacement surgery on (b)(6) 2014. The generator was replaced due to battery depletion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3838722
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dennis100
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« Reply #14 on: April 12, 2018, 12:35:05 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 02/21/2017
Event Type  Injury   
Event Description
Since generator replacement surgery, patient has been experiencing constipation, urinary retention, decreased vocal volume and loss of appetite. These symptoms resolved when a magnet was placed over the generator and returned when the magnet was removed. Grandparents presented video recorded just prior to being turned off and following turning back on that support this (patient's voice volume returned to a normal baseline). At the time of generator replacement, patient had not experienced the above side effects. At the time of replacement, the patient¿s new vns settings were the same as the previous settings. The physician decreased the pulse width based on this observation and grandparents are to continue monitoring the patient. No additional relevant information has been received.
 
Event Description
Additional information was received that there have been no changes to medications since the generator was replaced. Patient does not have history of constipation prior to generator replacement. After replacement, patient had significant constipation that was unresponsive to medical intervention. When generator was turned off for a few hours over multiple days constipation resolved, the generator is currently off and there is no constipation. Consult with urology for evaluation of urinary retention noted that constipation was the etiology of retention. With resolution of constipation, urinary retention has resolved. Decreasing settings, short trial periods of turning the generator off followed by permanent turn off were performed as interventions. Two view chest x-rays were taken to assess for wire integrity, which was negative. Upon recent follow up with the family, all symptoms have resolved since turning the device off except for decreased appetite. Patient's vocal volume has also returned to normal with device disablement. Per the nurse practitioner, review of records indicate that weight loss secondary to decreased appetite developed with the introduction of a medication. This started prior to vns generator change. The nurse practitioner is currently lowering medication as a means to improve patient's appetite.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6639108
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« Reply #15 on: April 12, 2018, 12:35:39 AM »

Model Number 106
Event Date 09/01/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient had been experiencing an increase in seizure frequency and duration. The patient had two 4-minute seizures in one month and it was noted that the length of the seizure was unusual for the patient. The patient had also been experiencing hyperventilation and reported that his head was not feeling well. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient¿s issues were not related to vns but to an endocrine problem that resulted in a loss of appetite.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4309662
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« Reply #16 on: April 12, 2018, 12:36:15 AM »

Model Number 102
Event Date 02/20/2008
Event Type  Death   
Event Description
Reference mdr number: 1644487-2008-00247 for previous vns surgery. Initial reporter called to report that a patient who had vns surgery three weeks prior had died. The cause of death is unknown and thought to have been "natural causes. " no autopsy has been performed and the products were not explanted. It was reported that the patient had replacement of a lead cable and generator in 2007. The patient suffered prolonged nausea, vomiting and appetite loss. Because of her symptoms, the vagus nerve stimulation was not restarted after the replacement surgery. She was found to have mildly elevated lipase, but it was normalized after several days. Her symptoms got better gradually and the vagus nerve stimulation was restarted in 2008. The implanting surgeon was informed by patient's family that she died seven days later. "on this day, she was not feeling well in the morning. She told her parents she just wanted to rest. She died at home in her room". The implanting surgeon believed the nausea, vomiting and appetite loss are related to the vns replacement surgery, because these symptoms started right after the surgery. It is presumed the elevated lipase levels were not directly related to the vns per the treating neurologist. Precise cause is unknown. No testing done, no formal diagnosis for it.
 
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient had died on (b)(6) 2008 due to causes of, "epilepsy, unspecified, sequelae of other specified infectious and parasitic diseases, and other and unspecified convulsions. " a sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of probable sudep. There is no allegation or other information indicating that the death is related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1026535
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« Reply #17 on: April 12, 2018, 12:37:03 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 03/28/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient stopped eating since the vns stimulation off time was changed from 5 minutes to 3 minutes. Due to the shorter off time, the auto stimulations per day also decreased from 120 to 80 as the physician expected. No other reasons are known for patient's behavior. As a result, the physician changed the off time back to 5 minutes approximately 48 hours after she stopped eating to see if the patient's behavior will return to baseline. Neurologist hasn't heard back from patient yet regarding improvement. The decrease in patient's appetite is believed to be due to vns stimulation. System diagnostics were run twice, and both were reported to be ok.
 
Event Description
Additional information was received from the neurologist that the patient is doing better.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6514969
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dennis100
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« Reply #18 on: April 14, 2018, 12:46:16 AM »

Model Number 103
Event Date 02/07/2013
Event Type  Malfunction   
Event Description
On (b)(4) 2013 it was reported that the patient has seemed depressed, agitated, and has a decreased appetite recently. No device issues are suspected. The patient's device was adjusted from 1. 75 ma back to 1. 5 ma output as the 1. 75 ma was too strong with a pulse width of 500 usec. Diagnostics tests were fine. The patient could not tolerate the higher settings and has been under more stress lately. The physician believes that vns has helped the patient and there was no medication changes. The only further information the physician provided was that the patient is doing well when they decreased the amplitude and on time; there is "no complaint now". No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2989153
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dennis100
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« Reply #19 on: April 21, 2018, 01:31:59 AM »

Model Number 304-20
Event Date 04/26/2013
Event Type  Malfunction   
Event Description
Clinic notes dated (b)(6) 2013 were received which provide the patient's settings that are indicative of high impedance. The cover letter of these notes indicate the patient has had an increase in seizures. A review of the manufacturing records for the lead confirmed that the lead met all final testing specifications prior to distribution. Ap and lateral x-ray images of the neck and chest dated (b)(6) 2013 were received and reviewed. The generator was seen in normal orientation within the left chest area. The filter feed thru wires were intact. It could not be assessed if the lead was intact at the connector pin. The lead pin could not be seen past the connector block; however, it cannot be confirmed if the lead pin is fully inserted due to the angle of the generator in the image. A break was observed in the lead body beyond the anchor tether and negative electrode in the lead. Small pieces of lead were visualized in the neck area near the two tie-downs. There was no strain relief present as there was no lead beyond the anchor tether. The lead appeared twisted and coiled in spirals near the generator at the connector pin, indicative of patient manipulation or trauma. A portion of the lead appears to be behind the generator. The electrodes were observed in the neck and appear to be in proper alignment. Based on the x-ray images provided, the cause of the high impedance is likely the observed lead break identified in the lead body. Although the x-ray images were indicative of patient manipulation, follow up found that the patient's mother denied any patient manipulation or trauma. It was also stated that the patient has had diagnostic results performed three times since the implant surgery with normal results, so the lead pin must have been inserted into the generator at least initially. The patient's mother additionally reported that the patient has started having nausea and vomiting. It was unknown if the nausea and vomiting are related to vns, so the patient was referred for evaluation on gallbladder issues and lab work. The physician also increased the patient's keppra due to the reported increased seizures. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards prior to distribution. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death.
 
Event Description
The explant facility does not return explanted devices, therefore, the product will not be returned and product analysis cannot be performed. Follow up with the physician confirmed that the patient had manipulated the device as seen on x-rays and in the explant surgery. The device was disabled on (b)(6) 2013. The patient's mother initially did not believe that the patient had manipulative behavior, but she believed it after the surgeon showed her pictures from the surgery. The nausea, vomiting and decreased appetite may have been unrelated to vns or related to the manipulative behavior for attention, but it is unclear. The increased seizures were at pre-vns baseline and were believed to be related to the lead fracture. After the device was turned off, the seizures decreased again. No additional information was available.
 
Event Description
Clinic notes dated (b)(6) 2013 indicate that the patient¿s mother reports that since the placement of the vns device in february, the patient has refractory nausea and vomiting, and is unable to eat without subsequent weight loss. In fact, seizure frequency has also increased. The patient¿s mother requested removal of the entire vns system. Other sources for the nausea and vomiting symptoms were searched; however, a gallbladder and upper gi workup were negative and all symptoms coincided with the placement of this device. Per the notes, the physician agreed to the removal, as there is apparently an abnormality at the leads relative to the generator ¿ possibly a loose connection. The patient¿s device was explanted on (b)(4)2013. Pictures of the explanted device during surgery and x-ray images indicate the patient has manipulated the device, as the lead was coiled. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3129675
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« Reply #20 on: May 02, 2018, 01:55:52 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 10/23/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient has decreased appetite and was diagnosed with right vocal cord paralysis due to vns lead revision surgery. The patient's new device was programmed to the lowest settings following the surgery and diagnostics were reported to be within normal limits. Lead was replaced due to low impedance and this event was reported in mfr. Report # 1644487-2017-04807. The neurologist and ent are closely monitoring patient's progress. The neurologist does believe that vocal cord paralysis may have caused lack of appetite.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7280279
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« Reply #21 on: May 19, 2018, 02:31:46 AM »

Model Number 102
Device Problem Low battery
Event Date 05/23/2017
Event Type  Injury   
Event Description
Report received that a patient was referred for a generator replacement. It was thought that the battery had depleted since the patient could no longer feel stimulation and the generator could not be interrogated. Over the three months after the battery had likely depleted, the patient gained 20 pounds due to an increased appetite. It was also reported that the patient had a decrease in the quality of her sleep which the patient admitted might be related to anxiety over her generator battery depleting. The patient's generator was later replaced and the reason for replacement was listed as battery depletion on the implant card. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7051028
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« Reply #22 on: May 19, 2018, 02:32:27 AM »

Device Problem No Known Device Problem
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
An email was received from the head of therapy at the (b)(6) asking about a specific patient's side effects. The patient was having a loss of appetite, and discomfort, itching, and ringing in the ears with vns. The patient's symptoms reportedly stopped after the vns device was disabled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6569006
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« Reply #23 on: May 19, 2018, 02:33:21 AM »

Model Number 103
Event Date 07/01/2010
Event Type  Injury   
Event Description
The vns patient recently had surgery to replace the vns device in (b)(6) 2010 (previously reported in manufacturer report # 1644487-2010-01171), and since surgery, the patient had been experiencing pain in the left neck and the face. The physician had lowered the device settings to help with the pain. Over the next week the pain had resolved and the patient was doing well. It was then reported that the patient began experiencing intermittent seizure activity and confusion on (b)(6) and went to the emergency room. The patient was transferred to a different hospital, and the physician had made minor adjustments to the vns settings, and she was observed for several days but became very ataxic. After the physician's reviewed, the patient's medication, it was noted that the patient had taken an older (expired) bottle of lyrica to the hospital and was receiving twice the prescribed amount. After realizing the issue with the medication, it was corrected and the ataxia resolved and the patient was discharged. The patient was then for a follow up appointment at (b)(6) and the patient was experiencing migraine headaches, which per the physician is usually a sign of latent seizure activity. The physician opted to increase the device settings. Several days later, the patient then experienced a fairly severe migraine with confusion for the majority of the day, which seemed to resolve with no interventions. The patient is being closely monitored by the physician. At the time the patient was experiencing the migraines and confusion, it was also noted that the patient has not had a bowel movement for approximately a week, and the patient's appetite was diminished. The physician additionally explained that the patient is under a great deal of stress in her life at the moment, which could also be a contributory factor. At this time, the physician's assessment regarding the relationship of the events to vns is unclear. Good faith attempts to obtain additional information from the treating physician are currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1828271
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« Reply #24 on: May 19, 2018, 02:34:22 AM »

Event Date 03/19/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient was able to tolerate an output current programmed to 1. 25ma but began experiencing adverse effects when the output current was programmed to 1. 5ma. Since this programming change, the patient was experiencing anorexia, decreased appetite, constipation and urinary retention. The physician decreased the output current to 1ma; however, this did not resolve the patient¿s issues. The patient¿s device was programmed off. The patient¿s issues resolved when her device was programmed off. Attempts for additional relevant information were made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3750550
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« Reply #25 on: May 19, 2018, 02:35:15 AM »

Model Number 103
Event Date 08/12/2014
Event Type  Injury   
Event Description
It was reported that the study patient experienced an increase in seizures, epigastric pain with hospitalization, loss of appetite, vomiting, diarrhea and nausea. An adverse event form was received indicating that the patient experienced vomiting, diarrhea and gastroenteritis. It was reported these events were not related to vns and have been resolved. No additional relevant information has been received to date.
 
Manufacturer Narrative
Report source; corrected data: the previously submitted mdr inadvertently did not indicate "study" as a report source.
 
Manufacturer Narrative

Event Description
Further information was received which disregarded vomiting and diarrhea as individual adverse events. The reported gastroenteritis was not associated with congenital anomalies or birth defect, it did not result in a persistent or significant disability or incapacity and it was not associated with other serious or important medical events. The reported gastroenteritis was not a life threatening event and it did not result in death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4278678
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« Reply #26 on: June 04, 2018, 12:21:47 AM »

Event Date 08/01/2006
Event Type  Injury   
Manufacturer Narrative
Article citation: wilfong, angus, and rebecca schultz. "vagus nerve stimulation for treatment of epilepsy in rett syndrome. " developmental medicine & child neurology (2006): 683-86. Print.
 
Event Description
It was reported in a scientific article that a vns pt experienced decrease in appetite and coughing/choking on food after 1 month of vns therapy. These symptoms did not resolve despite reductions in vns stimulation parameters and the pt subsequently underwent placement of a gastrostomy feeding tube. The author reported that the symptoms seen in the pt may have been related to vns therapy, but in the physician's experience, these symptoms were more likely a result of the natural clinical history of rett syndrome.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1552698
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« Reply #27 on: June 10, 2018, 12:48:58 AM »

Model Number 103
Event Date 01/01/2010
Event Type  Injury   
Event Description
It was reported that the pt had stopped eating after implantation of vns device. The physician does not attribute this change to the vns device. However, they are considering stopping the pt's vns therapy to see if it has any impact. The pt is in a group home, is mentally retarded, and non-verbal. The pt has lost a significant amount of weight and his health is in peril. Clinic notes indicate that there have been times where he had refused to eat in the past. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1672110
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« Reply #28 on: July 17, 2018, 03:51:33 AM »

Event Date 11/01/2013
Event Type  Injury   
Event Description
An article titled "perforated peptic ulcer in a child with a vagus nerve stimulator for seizure control" was reviewed. The article indicates that a (b)(6) year old male with a severe form of epilepsy presented with a perforated peptic ulcer. The patient presented to the emergency department with fatigue, decreased appetite, headaches and chest pain. There was no recent seizures activity, nausea, or vomiting. The patient subsequently underwent exploratory laparotomy, which demonstrated a perforation of the anterior aspect of the duodenal bulb. It was noted that the patient subsequently recovered and was treated with a proton pump inhibitor for acid suppression.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3939274
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« Reply #29 on: January 04, 2019, 09:11:50 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient had been losing weight. Caregiver stated that the patient would only want to eat once a day and had lost 30 pounds. Per neurologist, the patient gained 30 pounds in the past 3 years until the most recent vns surgery. After the surgery, the patient lost 30 pounds. Patient does not have any history of eating disorders. The neurologist stopped a medication as it might have contributed to the weight loss but the patient's weight did not increase despite this change. Neurologist also added a new medication to help stop the weight loss but this was not effective. Due to the very close temporal relationship between implant surgery and onset of weight loss, the neurologist believes that there is a causal effect with vns therapy. Vns settings have been significantly reduced to see if that helps increase appetite. A review of device history records for the generator shows that no unresolved non-conformances were found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8180824&pc=LYJ
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