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dennis100
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« on: May 05, 2016, 02:58:30 AM »

Model Number 103
Event Date 02/01/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported through clinic notes that the patient was experiencing behavioral dysfunction and learning difficulties. It was also noted that the patient had experienced a seizure however baseline seizure rate is unknown. The physician believed these symptoms may be related to the generator being at ifi=yes. The patient was then referred for generator replacement which occurred on (b)(6) 2016. To date the explanted generator has not be returned for product analysis. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5609073
« Last Edit: February 07, 2017, 05:03:15 AM by dennis100 » Logged
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« Reply #1 on: May 05, 2016, 02:59:10 AM »

Event Date 03/31/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported in clinic notes dated (b)(6) 2016 that the patient was experiencing breakthrough seizures and cognitive changes which the physician attributed to the vns eos condition. Additionally, the notes referenced that the patient had previously experienced soreness in the throat when programmed to higher vns settings. The patient was then referred for a generator replacement. No surgical interventions are known to have occurred 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=5611448
« Last Edit: November 29, 2016, 01:59:58 AM by dennis100 » Logged
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« Reply #2 on: June 06, 2016, 01:18:54 AM »

Model Number 300-20
Device Problem Human-Device Interface Issue
Event Date 10/06/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
Follow-up to the physician¿s office revealed that the patient had gained 15 kilograms since deactivation of vns. It was reported that the patient was programmed to 0. 75ma, which was where the coughing and choking stopped, prior to the device being disabled. There had been no change in quantity of seizures or stability since the device was disabled. The patient¿s family was anxious to remove the device as it was believed the device is no longer needed. The weight gain was considered positive for the patient. An increase in cognition was reported since the device was disabled. The x-rays taken did not show any device issue. Diagnostics were performed with the patient in multiple positions to rule out an issue related to the position of the device and the diagnostics were reported to be the same in multiple positions. No known surgery has occurred to-date.

Event Description
A patient reported to their physician that he could no longer feel the vns activating. The physician increased the normal output current stimulation from 2. 00ma up to 2. 25ma. The patient had an adverse reaction to this increase causing him to cough and choke. The physician then reduced settings until the patient could tolerate them. The patient later reported on a follow-up visit on (b)(6) 2015 that he had previously experienced a fall and chest trauma and that he could feel the vns activating at the generator site. Normal mode diagnostics indicated an impedance reading of lead impedance=ok, dcdc=0, near end of service=no. The physician suspected the lead had a short circuit based on the dcdc value of 0, although this result was on normal mode diagnostics rather than systems diagnostics. The device was disabled on (b)(6) 2015, and it was indicated that the patient wants to try medicine alone. X-rays were ordered by the physician, but have not been received by the manufacturer for review. A review of the available programming history in the manufacturer's database showed the last normal mode diagnostics on (b)(6) 2014 to have an impedance value of dcdc=4. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5232917
« Last Edit: November 29, 2016, 02:00:31 AM by dennis100 » Logged
dennis100
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« Reply #3 on: June 06, 2016, 01:19:35 AM »

Model Number 105
Event Date 10/26/2015
Event Type Injury
Manufacturer Narrative
Suspect device udi: (b)(4).

Event Description
It was reported that the patient was having issues at school with following her assignments. It is believed by the caregiver that the patient is having increased seizures as well. Patient is also sometimes speaking with a lisp. Additional information was received that the cognitive changes appeared to have resolved with a therapy level adjustment. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5236894
« Last Edit: November 29, 2016, 02:00:48 AM by dennis100 » Logged
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« Reply #4 on: June 07, 2016, 12:31:00 AM »

Model Number 101
Event Date 08/06/2010
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that before the patient's previous implant on (b)(6) 2011, the patient had some arm posturing and cognitive declines. It was also reported that the patient had a dramatic improvement once that battery was replaced. The explanted generator was received by the manufacturer for analysis. Analysis of the generator concluded that no performance issue or any other type of adverse condition was found. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5228873
« Last Edit: November 29, 2016, 02:01:04 AM by dennis100 » Logged
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« Reply #5 on: July 14, 2016, 12:06:35 AM »

Model Number 101
Event Date 01/01/2011
Event Type Injury
Event Description
It was reported that a patient was experiencing cognitive changes and admitted to the hospital; specifically, the patient was experiencing post-seizure psychosis. The event was described as the patient having a seizure and then becomes psychotic and tries to remove the vns device. The patient has reportedly tried this before and the physician would like to have it removed before the patient causes serious harm to himself. It is unknown when the cognitive changes began to occur. It was noted that the patient is to undergo explant surgery, of which the date is unknown. Good faith attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2282313
« Last Edit: November 29, 2016, 02:01:20 AM by dennis100 » Logged
dennis100
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« Reply #6 on: July 17, 2016, 02:05:36 AM »

Model Number 105
Event Date 06/05/2015
Event Type Injury
Manufacturer Narrative
Suspect device udi: (b)(4).

Event Description
It was reported that this patient experienced dizziness, vomiting, fever, ambulation difficulties, and cognitive changes after a follow up dosing appointment for vns. Patient¿s vns therapy level was adjusted on (b)(6) 2015 and the dizziness and other events began on (b)(6) 2015. Patient was taken to the er and the physician in er indicated that these events might be due to patient¿s medication. Lamictal has been stated to be a possible cause of the problem but has not definitively been determined to be the issue. No medication adjustments have been made to the patient following their implant. Patient¿s medication levels are to be checked prior to confirming the cause of patient¿s issues. Attempts for additional relevant information were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4887096
« Last Edit: November 29, 2016, 02:01:37 AM by dennis100 » Logged
dennis100
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« Reply #7 on: July 29, 2016, 03:49:31 AM »

Model Number 102
Event Date 03/18/2013
Event Type Injury
Event Description
Reporter indicated a patient was experiencing increased seizures, headaches, and emotional issues and that these events indicated the vns may be nearing end of service as these behaviors were also observed before a previous generator replacement. A manufacturer battery life estimate performed resulted in over 4 years remaining, indicating end of service is unlikely. Surgery to replace the vns generator is planned, but has not occurred to date. All attempts for additional information have been unsuccessful to date.

Event Description
Reporter indicated the patient¿s increased seizures were felt to be due to ¿decreased function vns¿. The vns generator was replaced as an intervention, but the outcome was not provided. More than one seizure type increased, but the types were not specified, and the level of the seizure increase was not provided. The headache and cognitive changes were felt to be due to ¿tension headaches¿ and the headaches were random and not occurring with vns stimulation. No causal or contributory programming or medication changes precede the onset of the headaches or cognitive changes, and the patient does have a pre-vns history of headaches and cognitive changes. The vns was reported to be functioning properly; ¿working fine¿. No programming changes or other events preceded the seizure increase. The patient had generator replacement surgery on (b)(6) 2013. The explanted generator will not be returned per hospital policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3062835
« Last Edit: November 29, 2016, 02:01:53 AM by dennis100 » Logged
dennis100
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« Reply #8 on: July 29, 2016, 03:50:20 AM »

Model Number 102
Event Date 11/08/2007
Event Type Injury
Event Description
On (b)(6) 2013, it was reported that the vns patient had to have the vns turned off due to severe side effects and he was still depressed. It was previously reported on (b)(6) 2007 that the patient has made suicidal gestures. Further follow up with the physician revealed that the gestures were not related to vns therapy. Additionally, the patient's treating medical professional indicated that patient was experiencing vomiting, nausea, dyspepsia and headache on (b)(6) 2008. The medical professional has stated that all these events can be related to vns. Even though the patient has had medical history of these problems, they appeared to be worsened with vns stimulation. An additional event of cognitive changes where the patient was entering dream states was reported. Follow up with the treating medical professional revealed that the event is believed not to be related to vns therapy, but likely related to the patient's underlying psychiatric condition. The patient is reportedly doing better with emotional freedom exercises and they are considering putting the patient on an anti-psychotic. An additional report was received that this patient is experiencing side effects from vns including difficulty breathing, migraine, photophobia, nausea, indigestion, and reflux. Good faith attempts were made for additional information, but were unsuccessful. Even though a response was not received regarding diagnostics results, investigation of a report of cognitive changes showed the device to be functioning properly on (b)(6) 2008. No additional information was received regarding the dyspnea and visual disturbances events. Additional information from the site indicated that diagnostics on (b)(6) 2008 showed the device to be functioning properly. The physician indicated that all events except migraines were present from the first stimulation. The migraines and photophobia events began after the output current was increased. The dyspnea and dyspepsia events are associated with stimulation on times. It appears the patient had reflux 10 years ago, and the gi symptoms reappeared with vns therapy. It appears that the cognitive changes had disappeared, and then recurred about 2-3 times in one week. An additional contributing factor to the migraines and photophobia is the patient's hypertension. Decreasing the pulsewidth has seemed to help these events. Medication is being administered for the dyspepsia and migraine events. The patient is still undergoing relaxation techniques and therapy. The programming history database was searched. The patient was last programmed to output=1. 75ma/frequency=30hz/pulse width=130usec/on time=30sec/off time=5min/magnet output=0ma/magnet pulse width=500usec/magnet on time=60sec on (b)(6) 2010. The last system diagnostics test was from (b)(6) 2009 which showed output=ok/lead impedance=ok/dcdc=3/eri=no. On (b)(6) 2012 a nurse stated that the patient's output current was increased from 1. 75 to 2. 25, signal frequency decreased from 30 to 25, and off time was increased on (b)(6) 2011. The patient's side effects then became intolerable. On (b)(6) 2011, they turned the device completely off after the patient had turned it off with his magnet for a trial period from (b)(6) 2011. The patient still has the device turned off at present and the patient has since felt better. Additional information was received on when a form dated (b)(6) 2011 from the physician stated that the patient's reflux/indigestion and migraines resolved after turning off the vns. The physician later reported that the lack of efficacy was first observed on (b)(6) 2007. The patient was noted to have severe refractory depression that has been and continues to be non-responsive to therapy, medications, and vns.

Event Description
On (b)(6) 2013 the physician¿s nurse stated that the vns was not working for this patient, the patient just never got better. The patient had severe side effects and just had a really rough time with vns. The patient¿s depression didn¿t get better. The nurse stated that she thinks it is related to his underlying illness, being treatment resistant. She also mentioned that he has a history of suicidal thoughts ongoing and some suicidal gestures. She mentioned that he started or continued to have suicidal thoughts very shortly after he was implanted and the vns was turned on. She said she thinks it was because he thought the vns was going to work for him and it didn¿t. The nurse stated that she looked over the patient¿s progress reports and she saw where the device was turned on at 5. 5 weeks and the patient didn¿t feel that his mood had changed. The patient was still feeling depressed and having a lot of side effects.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3118167
« Last Edit: November 29, 2016, 02:02:08 AM by dennis100 » Logged
dennis100
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« Reply #9 on: August 10, 2016, 08:34:16 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2082998
« Last Edit: November 29, 2016, 02:02:25 AM by dennis100 » Logged
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« Reply #10 on: August 20, 2016, 02:24:58 AM »

Model Number 102
Event Date 05/06/2012
Event Type Injury
Event Description
It was reported by a company representative that a vns patient experienced loss in weight and cognitive changes 10 days after starting vns stimulation. The patient's settings at the time of the reported events were. 25 ma, 20 hz, and 250 msec. No medication changes were noted to have had contributed to the loss in weight and mood changes. The patient does not have any pre-vns condition of behavioral changes. Additional information from the area representative indicated the patient's mood and behavior are stable as of last office visit in (b)(6) 2012. Moreover, additional information was received from the area representative indicating the patient has acute psychotic symptoms including but not limited to poor attention, mood changes, intake of food, sleep and bizarre behavior by threatening to hurt caretakers. The treating physician programmed the patient's vns off and referred the patient to a psychiatrist. Information from the treating physician through the area representative indicated the psychotic symptoms are of unknown relationship to vns therapy; hence the physician decided to program the patient's device off. No further information was available as good faith attempts have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2633248
« Last Edit: November 29, 2016, 02:02:40 AM by dennis100 » Logged
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« Reply #11 on: September 15, 2016, 02:34:26 AM »

Model Number 103
Event Date 01/02/2013
Event Type Injury
Manufacturer Narrative

Manufacturer Narrative
Some information was inadvertantly not included on initial mdr.

Event Description
Follow up with the physician indicated that the patient has a rather sever neurodevelopmental disorder, so he could have an abnormal hypothalamic system, but no definite or defineable condition. The physician does not plant to turn the device back on. Additionally, it had been initially reported that medication changes were not believed to have a relation to the event; however, this was inadvertently not included on the initial mdr.

Event Description
It was reported that the physician is not sure of the relationship to vns therapy. No further information was provided.

Event Description
On (b)(6) 2013, it was reported that the vns patient has been experiencing hypothermia and cognitive changes when the device is turned on. It was later reported that the vns patient has a history of hypothermia and was hospitalized for a low body temperature on (b)(6) 2013. On (b)(6) 2013, the vns device was turned off and the patient¿s body temperature went back down to a body temperature ranging from 94-96 degrees. The device was turned back on and their body temperature was observed to be 92-93 degrees. On (b)(6) 2013 the patient¿s device was turned on and the patient¿s body temperature went back down again. On (b)(6) 2013, the patient¿s device was turned back off. The physician confirmed that the patient has a history of cognitive issues and he does not believe that the patient's cognitive changes are above baseline. No other interventions have been planned or are anticipated at this point. The physician has not determined that the patient¿s experience of hypothermia is related to vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3237681
« Last Edit: November 29, 2016, 02:03:06 AM by dennis100 » Logged
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« Reply #12 on: November 29, 2016, 02:03:56 AM »

Model Number 105
Event Date 04/01/2016
Event Type Injury
Event Description
Information was received indicating that the patient was seeking an explant surgery to remove their vns. Clinic notes that were received indicated that the patient had an increase in seizures above pre-vns levels, and cognitive changes. The cognitive changes include a change in consciousness, and staring and unresponsiveness. The patient then had their device disabled by the physician and their number of seizures reduced, sense of smell increased and the patient became "clearer headed. " the physician stated that they believed the vns was broken. When asked for clarification, the physician reached this conclusion because of the patient's clinical symptoms. No diagnostic information was given but patient's settings were. No other relevant information has been received to date and surgery has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5997194
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« Reply #13 on: February 07, 2017, 02:16:46 AM »

Model Number 101
Event Date 10/02/2000
Event Type Injury
Event Description
New information was received from the surgeon indicating the electrode array portion of the lead was not removed from the vagus nerve, and remains implanted in the patient.

Manufacturer Narrative

Event Description
It was reported that the patient had cognitive changes and starts to act semi-violent at higher settings, and that the benefits of the vns therapy is not noticeable. The physician was contacted for additional information but no response was received to date. It was also reported that the patient's vns device will be explanted, but the date of surgery is unknown to date.

Event Description
It was reported that the patient had the vns generator and the lead explanted. It was confirmed that the vns generator and lead will not be returned to the manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2967740
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« Reply #14 on: February 14, 2017, 02:51:35 AM »

Model Number 102
Event Date 01/01/2007
Event Type Malfunction
Event Description
Additional information was received from the physician indicating that he does not believe there is any relationship between the reported events and vns. The patient did not report any of these symptoms to the physician and the physician indicated that the events are likely related to the patient's chronic psychosis. No programming or medication changes are believed to have caused or contributed to the noted events. The physician noted that the patient has a history of schizophrenia that preceded vns.

Event Description
It was reported by the vns patient that the vns in combination with environmental factors was causing him to have cognitive difficulties that he did not have prior to vns. He has been reportedly experiencing this since a couple years following vns implant. The patient also indicated that he has depression and anger issues and is "on a lot of medication. " the relationship of the depression and anger issues to vns is unknown. It is unknown if the patient had a history of depression prior to vns. The patient also mentioned that he has attempted to overdose on two occasions. The relationship of these events to vns is unknown and the patient did not indicate when these events occurred. Attempts for additional information from the physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2502358
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« Reply #15 on: February 19, 2017, 02:38:43 AM »

Model Number 102
Event Date 10/18/2011
Event Type Injury
Manufacturer Narrative

Event Description
Further information received from the physician indicates that at the visit on (b)(6) 2011, the patient had "normal settings" and was at 0. 5 ma. Per physician, the increased seizures were back to pre-vns baseline levels and could be due to a "combination of factors". Patient has intractable epilepsy. The patient had an increase before vns placement and the vns was at low settings. Patient also reports stress and sleep changes which may have contributed to the seizures. Per physician, the patient did not report suicidal thoughts at the last visit, but did report anger and mood changes. The relationship of the level of suicidal thoughts to pre-vns baseline levels is unknown. No known patient manipulation or trauma occurred that is believed to have caused or contributed to the pain. The cognitive changes have multifactorial causes, per physician. The patient is frustrated that the seizures are not controlled and the primary care physician has made medication changes. No known causal or contributory programming changes, medication changes, or other external factors preceded the onset of the events. The patient has been treated for depression in the past by a different physician. The patient's settings were adjusted on (b)(6) 2011 visit and is scheduled for follow-up with physician. The patient was not diagnosed with arrhythmia and no cardiac testing was performed, but the patient reported that his "heart hurt" and felt palpitations. The patient has no history of cardiac issues. Physician does not believe the possible arrhythmia is related to vns, but is unable to rule it out. The event occurred following an increase in depression and seizures.

Event Description
It was reported by the patient's mother that things have gone "downhill" since the patient saw the physician on (b)(6) 2011 to have titration performed. She stated that her son was implanted a couple of months ago and has been set to a very low output current since implant. On (b)(6) 2011, the physician changed the output current to 1 ma (which was a large jump according to the patient's mother). She stated that her son expressed to the physician how much pain he was in and said he didn't want to go that high yet, but the physician told him that she could not turn it down. The patient's mother thinks that the physician might have turned his output current back down to 0. 75 ma or 0. 5 ma but isn't sure. No history is currently available to confirm the patient's settings. Since the visit, the patient has been in intense pain during stimulation. In addition, the mother reported that the patient also has a flutter in his heart and his heart rate changes with the stimulation. Patient has experienced an increase in seizures that is above pre-vns baseline levels and the patient has become very angry since the setting change. The patient's mother went on to say that the patient has become so angry that he has had suicidal thoughts. She clarified that this was only once and that they were monitoring him closely and he seems to not have considered that anymore. The patient had an appointment on (b)(6) 2011 and has reportedly been doing very well since that appointment when the settings were changed. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2341562
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« Reply #16 on: April 19, 2017, 12:30:31 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 11/30/2010
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported through an article that two depression patients experienced manic episodes believed to be caused by a latent bipolar disorder triggered by the vns. The other patient is captured in mfr. Report # 1644487-2010-02812. Approximately eight months after vns implantation, this patient began to demonstrate manic episodes, cognitive changes, and sleep disturbances that were associated with vns therapy. The patient reported sleeping less than 2-3 hours per night, and he exhibited changes in his interactions with others. He was noted to be exhibiting multiple symptoms of hypomania: logorrhea, disinhibition, displaying mild irritability, and hyperkinetic behavior. No psychotic symptoms were noted. The patient was started on a mood stabilizer regimen of valproic. After this, his manic symptoms appeared to resolve. Follow-up with the patient's treating psychiatrist confirmed that he believed the manic episodes to be caused by the vns and not related to medication. He considered it a serious injury but indicated that the patient was doing well at the time of the report. He said that this was actually a good indication that the vns was working since all anti-depressants have the potential to trigger manic episodes. Prior to his vns implant, the patient had never exhibited any symptoms consistent with mania or hypomania. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6394693
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« Reply #17 on: May 18, 2017, 12:55:26 AM »

Model Number 302-20
Event Date 01/01/2008
Event Type  Malfunction   
Manufacturer Narrative 
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description 
It was reported that over the past year, and even more over the past 2 or 3 months, a vns patient has had an increase in seizures. Medications were adjusted. There was still some decline in the patient's seizure control and some cognitive decline as well. The physician indicated the patient's vns device was unable to be interrogated, and a "dysfunctional battery" is suspected. Generator revision surgery was planned, and the physician indicated that x-rays showed vns to be intact. However, he was not able to perform diagnostic testing to confirm that vns was functioning properly. After the surgery, it was reported that diagnostics resulted in high lead impedance, and the patient underwent full revision of both the generator and lead. Good faith attempts to obtain additional information have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1277705
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« Reply #18 on: August 21, 2017, 04:52:10 AM »

Model Number 300-20
Event Date 09/08/2011
Event Type  Malfunction   
Event Description
Additional information was received from the surgeon indicating that manipulation and trauma were not suspected, and x-rays were not taken. He was unable to provide any additional programming history and no additional information was provided.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported on (b)(6) 2011 that during a generator replacement procedure for end of service, a lead fracture was identified. The generator and lead were replaced at that time. The explanted products have been returned to the manufacturer; however product analysis has not yet been completed. Prior to the replacement, it was reported that the generator could not be interrogated as it had reached normal end of service. It was also reported that the patient was experiencing an increase in seizures as well as cognitive changes, which at that time were attributed to the end of service. It is unknown if the lead fracture contributed to the patient's reported adverse events.
 
Event Description
Product analysis on the explanted generator and lead has been completed. During product analysis on the generator, the alleged end of service was verified and determined to be the result of normal battery depletion. The depletion was an expected event as determined by a battery life calculation and battery voltage measurement. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. During product analysis of the lead, a lead fracture was identified in both the marked and unmarked connector quadfilar coils. Scanning electron microscopy was performed on the marked connector quadfilar coil break and identified the area as having extensive pitting which prevented identification of the coil fracture. Scanning electron microscopy was performed on the unmarked connector quadfilar coil break and identified the area as being mechanically damaged which prevented identification of the coil fracture type, no pitting and flat spots on coil surface. A third break was also identified approximately 2 mm from the end of the abraded open / torn outer silicone tubing. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type, no pitting and flat spots on coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. The positive electrode ribbon was returned embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the electrode ribbon from coming in contact with the vagus nerve; therefore contributing to the reported allegations. With the exception of the observed discontinuities and tissue-covered positive electrode ribbon, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pins at one point in time. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Note that since a portion of the lead assembly (body) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2349367
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« Reply #19 on: August 23, 2017, 04:03:07 AM »

Model Number 302-20
Event Date 10/17/2011
Event Type  Malfunction   
Event Description
It was reported that the patient had high impedance and was being referred for a full revision surgery. Patient has had no seizures with loss of consciousness since (b)(6), 2010 and then possibly a mild seizure without definite loss of consciousness on (b)(6), 2011 associated with pharyngitis. Has had declining memory and cognition in recent months. Attempts for further information have been unsuccessful to date.
 
Event Description
The patient underwent full revision surgery due to the high impedance on (b)(6) 2011. Per hospital policy, the explanted devices cannot be returned to the manufacturer for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2337738
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« Reply #20 on: August 24, 2017, 12:10:43 AM »

Model Number 102R
Event Date 07/01/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient's generator was explanted on (b)(6) 2011 and returned to the manufacturer on (b)(4) 2011. Product analysis is not yet complete. The reason for replacement, provided on the returned goods form, was reported to be end of service with elective replacement indicator (eri) =yes. Attempts for additional information have been unsuccessful to date.
 
Event Description
It was reported through clinic notes dated (b)(6) 2011, received on (b)(6) 2011, that the patient was experiencing an increase in depression. Symptoms include feelings of sadness, hopelessness, and thoughts of suicide. The patient was prescribed anti-depressants for the depression. The patient was also experiencing episodes of behavioral changes as well as staring spells. The patient has recently been referred for replacement surgery due to end of service however it is currently unclear if these events are related to the generator end of service. Revision is likely but has not occurred to date. Attempts for additional information are underway.
 
Event Description
Additional information was received from a nurse with the patient's treating neurologist, indicating that the events were likely not related to vns. She indicated that the depression and suicidal thoughts may be related to the patient's attention seeking behavior and be part of the patient's normal temperament and that they did not believe that there was any real threat to the patient's safety. The nurse also indicated that the cognitive changes and staring spells may be related to the patient's attention seeking behavior rather than being clinical symptoms. No additional information about the patient's symptoms was mad available. Product analysis on the generator has been completed and an end-of-service (eos) condition was found in the (b)(4) laboratory. Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an end-of-service condition. The pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2322725
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« Reply #21 on: September 08, 2017, 10:18:04 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient reported having an increase in seizures in the following months after implant (implanted (b)(6) 2016). The information received suggested the device was programed on shortly after implant and the neurologist made no changes at a follow up visit one month later but suggested the patient visit again in one year. Since then the patient visited a new neurologist who reprogrammed the device's settings. The patient reported improvement in focal seizures since the change as well as fatigue and some cognitive changes. No diagnostics or additional settings have been received to date. No additional or relevant information has been received to date.
 
Event Description
Information was received stating the patient's neurologist assessed the increase in seizures was due to the need for titration of settings and did not believe there was an issue with the patient's vns system. Autostim diagnostics were provided and indicated normal function. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7109367
« Last Edit: June 19, 2019, 04:26:11 AM by dennis100 » Logged
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« Reply #22 on: September 13, 2017, 02:01:53 AM »

Model Number 102
Event Date 03/13/2012
Event Type  Injury   
Event Description
It was reported by a vns patient's mother on (b)(6) 2012 that their child was experiencing cognitive changes and an increase in seizures that might have been over their pre vns baseline. Additionally, it was reported by the physician that the patient had a history of behavioral issues, and that the mother was overreacting. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2525665
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« Reply #23 on: October 22, 2017, 01:44:38 AM »

Event Type Malfunction
Event Description
An email with a link to a blog post titled (b)(6) was sent to the manufacturer. The blog was reviewed and three incidents of increased depression and one incident on cognitive behavioral changes were noted. This report is for the patient who experienced cognitive behavioral changes. The three increased depression events are reported in mfr report numbers 1644487-2013-03051, 1644487-2013-03052, and xxx. The blog writer stated that the thought of having the vns lead wrapped around her vagus nerve made her feel ill and claustrophobic. The writer states that she told the coordinator that "i can imagine freaking out and trying to rip it out of my neck", to which the coordinator responder (per the writer) that "that's happened". Implying that the event has occurred before. Attempts for additional information cannot be made as the patient for which this may have occurred and the physician information is unknown. It was noted that the person who wrote the blog post was a participant in one of the depression clinical studies; however, this participant was not implanted with vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3389230
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« Reply #24 on: December 11, 2017, 03:17:37 AM »

Model Number 100
Event Date 09/01/2000
Event Type  Injury   
Event Description
Clinic notes were received reported that a vns patient in (b)(6) 2000, developed aspiration pneumonia in association with a prolonged seizure and required a prolonged hospitalization. After this episode, she had an increase in nighttime seizure activity as well as significant weight loss. Despite a change in seizure medications, she continued to have intractable seizures without improvement. Consequently, she was transferred to another hospital for children in (b)(6) 2000. At that time, she was noted to be in status epilepticus. She was electively intubated and loaded with phenobarbital. She required multiple boluses of phenobarbital and dilantin to eventually control her seizures. Her vagal nerve stimulator was temporarily turned off at that time and reactivated later to help with seizure control. She was eventually extubated on (b)(6) 2000. She eventually required a nissen fundoplication and placement of a g-tube, as well as placement of a tracheostomy. This was required because of a significant regression in her speech, swallowing skills, mobility and cognition all of which occurred after her episode of status epilepticus on (b)(6) 2000. Prior to that time, she was able to walk and talk fairly normally. The patient has several different seizure types which occur frequently throughout the day. Thus far no further information has been received in regards to the patient's pneumonia and seizure events.
 
Manufacturer Narrative
 
Event Description
No further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2838233
« Last Edit: November 01, 2018, 02:52:51 AM by dennis100 » Logged
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« Reply #25 on: January 05, 2018, 04:39:28 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 08/01/2016
Event Type Injury
Manufacturer Narrative

Event Description
The patient reported having an increase in seizures in the following months after implant (implanted (b)(6) 2016). The information received suggested the device was programed on shortly after implant and the neurologist made no changes at a follow up visit one month later but suggested the patient visit again in one year. Since then the patient visited a new neurologist who reprogrammed the device's settings. The patient reported improvement in focal seizures since the change as well as fatigue and some cognitive changes. No diagnostics or additional settings have been received to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7109367
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« Reply #26 on: March 06, 2018, 03:47:12 AM »

Model Number 102
Event Date 10/04/2012
Event Type  Malfunction   
Manufacturer Narrative

Event Description
A review of clinic notes dated (b)(6) 2012 found that the physician checked the patient's vns and the vns indicated that the battery life was very near end of life. He further stated that the output current "self-adjusted to preserve battery life". He states that the current output current is 0. 75 ma, while the output current in (b)(6) was 2. 50 ma. It was stated that the magnet current similarly "self-adjusted from 2. 75ma" in (b)(6) to the current settings of 1. 00 ma. It was unclear in the notes if "self-adjusted" referred to the physician changing the settings himself, or if the device was found to be at lower settings than expected upon interrogation. In addition, it was noted that the patient experienced feelings of "being spacey" and having difficulty staying on-task. The patient's medications were increased while waiting to get the battery replaced, and a surgeon was referred. All attempts have been made to obtain further information; however, they have been unsuccessful. The patient was scheduled and underwent surgery on (b)(6) 2012. An implant card was received, which confirmed that the patient's generator was explanted on the surgery date and replaced. The reason for replacement was noted as "battery depletion" with near end of service marked unknown. The patient's product was returned on (b)(4) 2012, with the reason for product return listed as "battery died" and explant reason noted as "end of service (battery depletion) eri=unknown. Product analysis has not yet been performed on the returned product.
 
Event Description
Product analysis was completed and approved on (b)(6) 2012. The reported allegation of "spontaneous change in generator programmed settings" was not confirmed based on the vns programming history database. The programming history printout for this device shows no spontaneous change in parameter settings. The reported allegation of "cognitive changes" cannot be evaluated in the pa laboratory setting. However, the depleted battery may have been a contributing factor. The reported allegations of "no stimulation", "energy output to patient tissue incorrect", and "end of service" were duplicated in the pa laboratory and determined to be the result of normal expected battery depletion, based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2818487
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« Reply #27 on: April 03, 2018, 01:14:17 AM »

Model Number 304-20
Event Date 11/26/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected.
 
Event Description
Reporter indicated a patient had high lead impedance with vns systems diagnostics testing at an office visit on (b)(6) 2012. The patient's seizures had also worsened since the last vns setting adjustment and medication changes done on (b)(6) 2012. The patient had also had decreased cognitive functioning. The patient did have several falls in (b)(6) 2012 which may have precipitated the high lead impedance. X-rays did not show any frank lead breaks per the reporter. The patient had vns lead and generator replacement surgery performed on (b)(6) 2013. The explanted devices have been returned and are pending analysis. Attempts for additional information are in progress.
 
Event Description
Analysis of the vns lead and generator was completed. A break was identified in the positive lead coil. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the broken end. However, due to metal dissolution the fracture mechanism cannot be determined. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. An abraded opening in the outer tubing was also noted. Analysis of the generator did not reveal any anomalies, and the generator performed per specifications. Review of the internal generator data noted an impedance change occurred on (b)(6) 2012 from 3568 ohms (normal impedance) to 12819 ohms (high impedance). As the patient had been reported to have had falls in november 2012, it is suspected this may have contributed to the high impedance. All attempts to the reporter for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Date of event, corrected data: review of internal generator data during product analysis identified the high lead impedance occurred on (b)(6) 2012. Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2915911

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« Reply #28 on: April 11, 2018, 02:37:57 AM »

Model Number 102
Event Date 11/30/2009
Event Type  Death   
Event Description
It was reported that the vns patient passed away on (b)(6) 2009. The cause of death is unknown. Review of the available programming and diagnostic history showed normal diagnostic results through 2009.
 
Event Description
Additional information was obtained and it was found that the patient¿s date of death was actually (b)(6) 2009 and the patient passed away at the hospital. The patient was admitted to the hospital on (b)(6) 2009 with acute atrial fibrillation with fast response, hypotension, and probable pneumonia. The history of present illness details that the patient had serial life threatening problems over the last two months which included an intracerebral hemorrhage with resulting hemiparesis and marked cognitive and physical deficits. A feeding tube was placed a week prior to the hospital stay because of dysphagia and recurrent aspiration. The patient had an acute mi, pneumonia, svt, and blood pressure difficulties prior to placement. Tachycardia at a rate of 180 led to him being sent to the er. The svt proved quite difficult to control as he was found to have a large intraventricular clot that they did not anticoagulate because of the intracerebral hemorrhage. The physician wished to move the patient to hospice due to the poor prognosis, but his brother wanted gentle care. In a progress note addendum, the physician convinced the patient¿s family to move the patient to hospice care because ¿his prognosis is essentially zero. ¿ the patient had another mi while in the hospital, but the patient's heart rate and blood pressure somewhat stabilized. The patient was eventually discharged on (b)(6) 2009, the date of death.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Manufacturer Narrative
Outcomes attributed to adverse event: death, corrected data: the initial report indicated the date of death was (b)(6) 2009 however, it was (b)(6) 2009. The information has been corrected in this report. Date of event, corrected data: the initial report indicated that the date of the event was (b)(6) 2009 however it was (b)(6) 2009. The information has been corrected in this report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3673246
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« Reply #29 on: April 11, 2018, 02:39:08 AM »

Model Number 103
Event Date 10/01/2012
Event Type  Injury   
Event Description
Additional information as received on (b)(6) 2013 when it was reported that the vns patient underwent generator replacement surgery on (b)(6) 2013. It was also reported that high impedance was observed after the generator was replaced (reported on mfr. Report # 1644487-2013-00472). It was reported that the explanted generator could not be returned to the manufacturer for product analysis as the hospital requires a signed release from the patient, however they usually discard it.
 
Manufacturer Narrative

Event Description
On (b)(4) 2013 product analysis was completed on the explanted generator. An end-of-service warning message was verified in the pa lab and found to be associated with the pulse-disabled by the pulse generator. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 1. 855 volts, verifying an eos condition. With the exception for capacitor c4 out of specification, the post burn-in electrical test results showed that the pulse generator module performed according to functional specifications. This is not expected to have an adverse effect on battery longevity. The cause for the out of specification capacitor, c4, (v cpu) value is likely associated with component aging. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
On (b)(6) 2012 clinic notes were received dated (b)(6) 2012 which indicated that the patient has been complaining of intermittent chest wall pain overlying the vns for the last two weeks. The pain was non-radiating and intermittent in nature. Interrogation of the vns was attempted but a message was received that indicated "vbat less than eos threshold" and the generator is not supplying stimulation. The physician reported that the vns is not working properly at this time so the patient would be referred for battery replacement due to end of service. Although surgery is likely, it has not occurred to date. Good faith attempts for further information from the physician have been unsuccessful.
 
Event Description
Additional information was received on (b)(6) 2012 when clinic notes were received dated (b)(6) 2012. The clinic notes indicate that he patient has one grand mal seizure per week and has jerking through the day that is getting worse. The patient's mother reported that the vns has been turned up as much as possible but the magnet doesn't seem to be working. Recently the patient has had neurologic regression with both cognitive and motor regression. The vns was noted to be at end of life and the patient was referred for replacement of the vns. Good faith attempts for further information from the physician have been unsuccessful. Although surgery is likely, it has not occurred to date.
 
Event Description
On (b)(6) 2013 it was reported that the explanted generator would be returned for product analysis. The explanted generator was received for product analysis on (b)(6) 2013. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2870716
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« Reply #30 on: April 11, 2018, 02:40:23 AM »

Model Number 102
Event Date 09/01/2012
Event Type  Injury   
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".
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
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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« Reply #31 on: April 29, 2018, 01:59:33 AM »

Model Number 302-30
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
Additional information was received from the reporter on (b)(6) 2013 that patient had her generator programmed off several years ago and is still having seizures despite currently being prescribed aeds. It was also noted that the patient¿s 48 hour video eeg results showed seizures as having occurred.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed lead passed all functional tests prior to distribution.
 
Event Description
On (b)(6) 2013 it was reported that the patient¿s vns was turned off due to high impedance. The patient is having seizures. When they turned the device on, they ran diagnostics and the lead impedance was normal. They left the device turned off, added mycoline to the patient¿s medication, and she is doing better. They will turn the device back on if her seizures continue.
 
Event Description
The reporter indicated via phone call on (b)(6) 2013 that the patient had experienced a measurement of high impedance. It was reported that the patient's group home had disabled the generator as a result of the reading of high impedance. It was reported that the patient's physician would soon be performing a system diagnostics test on the patient's generator and that he might refer the patient for a surgical consult for a possible full revision of the generator and lead. A review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Follow-up with the physician on (b)(6) 2013 indicated that the patient's group generator was disabled on (b)(6) 2005 by the patient's group home because the patient had also been experiencing a lack of efficacy. A prior reported file indicates that the device was disabled because the patient was additionally experiencing cognitive changes at the same time as the report of lack of efficacy. Attempts for additional information are still in continuation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3163985
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« Reply #32 on: September 13, 2018, 01:55:25 AM »

Model Number 101
Event Date 10/18/2011
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
The implant card was received which also reported that the generator replacement surgery on (b)(6) 2012, was replaced due to battery depletion with near end of service=yes. Follow up with the physician's office confirmed that the patient's "cognitive difficulties" are not believed to be related to vns. Product analysis for the generator was completed, and the reported end-of-service allegations were confirmed. An open can measurement of the battery voltage determined that the battery was depleted. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition. The reported "failure to program" was duplicated in the lab and determined to be the result of normal battery depletion. With the exception of the eri parameter, the device performed according to functional specifications. There were no abnormal performance or any other type of adverse condition was found with the generator.
 
Manufacturer Narrative
Device manufacture date, corrected data: the initial report inadvertently did not include the specific date of manufacturer of the suspect device.
 
Event Description
It was reported that the physician could not interrogate the patient's vns and did not even realize the patient had a vns. The patient could not recall anything related to vns since 2002, but is a difficult historian. At this time, it is unknown if this is due to normal end of service or not. Last record of battery check is from 2005 and everything was okay. The patient has also had some "cognitive difficulties", but it is unknown if these are related to vns. Patient's seizures have not increased. Patient has been referred for generator replacement, but it has not occurred to date.
 
Event Description
The patient had generator replacement surgery due to end of service on (b)(6) 2012. The replacement generator was programmed to the patient's previous settings. The generator was received by the manufacturer, but product analysis has not been completed to date. The return product form was received and indicated the reason for replacement was due to battery depletion with eri=yes.
 
Event Description
It was reported that the patient's surgery was canceled as the patient has not completed cardiology clearance, and it has not occurred to date. Follow-up with the physician reveals that they feel the generator is at end of service as it has been implanted for quite some time and they have had no issues with their programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2348119
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« Reply #33 on: October 26, 2018, 01:40:17 AM »

Model Number 101
Event Date 01/01/2007
Event Type  Injury   
Event Description
It was reported that the patient was scheduled for vns explant due to an unknown reason. Upon further follow-up, the nurse at the treating physician's office reported on (b)(6) 2012 that the patient's device is being scheduled for explant because it was turned off some time ago for an unclear reason. She thought it may have been due to a low heart rate. Follow-up with the nurse revealed the patient had generator replacement on (b)(6) 2001, and on (b)(6) 2001, the patient was admitted to the hospital with low sodium of 120 on carbamazepine and levetiracetam. She was taken off carbamazepine, and was readmitted on (b)(6) 2001, with cognitive abnormalities on levetiracetam and phenytoin. She has a history of episodic tachycardia and is on betablocker since 2007. Patient was started on ltg in 2008, and the vns was turned off on (b)(6) 2008, due to tachycardia without underlying cause. Per the nurse, after having her device turned off for several years, the "episodic tachycardia remains unexplained, but she is taking a beta blocker". A note from the cardiologist dated (b)(6) 2008, stated that the patient's seizure medications were reduced and she had one significant seizure episode. Since then, she had more palpitations and some vague chest pain. Patient returned on this day for a follow-up due to recent increase frequency of palpitations. Patient had episodes of seizures about every two to three weeks, and it was noted that the patient had a vagal nerve stimulator placed. After the seizure episodes, the patient had palpitations usually at night and lasted for less than minutes, most consistent with probable premature beat feelings. The metoprolol sode was increased to "25 mg daily for pac or inappropriate sinus tachycardia suppression. She also had some vague chest pain and was initiated for cad evaluations. She also has some exertional fatigue. Otherwise, she denied any other cardiac-related complaints". Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
Date received by manufacturer, corrected data: the supplemental report #1 inadvertently reported the date the information was received by the manufacturer incorrectly. The correct date field was (b)(4) 2012.
 
Event Description
Additional follow up with the nurse was performed who reported that the details regarding the events are not remembered. The patient was complaining and being treated for tachycardia. The vns was turned off for an mri on (b)(6) 2008, and the patient had it turned back on (b)(6) 2008 reportedly. When trying to turn the output current on, the nurse reportedly "could not get the output past 0. 75ma" due to extreme coughing. Although the previous output current was 2. 0ma, the site attempted to turn the current to 1. 75ma but the patient experienced violent coughing. Current decreased to 1. 5ma with on time every 3 minutes and off time at 1. 8 minutes. The settings were not tolerated, and continued to not be tolerated at 1. 25ma. Current was therefore decreased. Due to the tachycardia, the vns was turned off soon after per the nurse (which was observed on (b)(6) 2008). Later on (b)(6) 2009, the notes indicated that the device had been turned off with no exacerbation of seizures over 6 months. Patient requested to have the device removed for reasons of pain and discomfort at night. Patient was referred for surgical consult for vns explant. Notes dated (b)(6) 2009 revealed that the patient requested to have vns removed, "as it has not been helping and is somewhat uncomfortable moving around in the pocket".
 
Event Description
Follow-up with the implanting surgeon revealed that from the generator replacement in 2008 there was no mention of a suture being used in the operative note of use of suture to secure the generator to the fascia. Training was provided to the surgeon's office regarding labeling recommendations that a non-absorbable suture be used to secure the generator to prevent such occurrences of generator migration.
 
Manufacturer Narrative
 
Manufacturer Narrative
Suspect medical device, lot number, expiration date, corrected data: the initial report did not report this product information at that time. Device manufacture date, corrected data: the initial report did not report the manufacturer date at that time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2883274
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dennis100
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« Reply #34 on: November 01, 2018, 02:54:23 AM »

Model Number 106
Event Date 01/01/2016
Event Type  Malfunction   
Event Description
It was reported by the vns patient's mother that whenever the patient's device settings were adjusted, the patient would experience increases in auras, seizures, post-ictal periods, headaches and twitching. The patient also began showing signs of cognitive impairment. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5444672
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dennis100
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« Reply #35 on: November 02, 2018, 08:44:56 AM »

Event Date 04/10/2012
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The patient had full revision surgery on (b)(6) 2012. The explanted products have been discarded and will not be returned for analysis. Lead information remains unknown. Good faith attempts for further info about the reported events have been made but no further information has been attained.
 
Event Description
X-rays were received and evaluated by the manufacturer. The generator was visualized in the left upper chest, the front of the generator is facing forward. The filter feed-through wires appeared to be intact. The lead connector pin appeared fully inserted into the generator connector block. Part of the lead was visible and could be assessed, part was behind the generator. Electrodes appeared correctly aligned on the vagus nerve. One possible acute angle was observed, near the generator. No obvious lead break could be identified in the visible portion of the lead. Additional information was received from the treating physician indicating the patient was experiencing absences and seizures and wanted a surgical decision. At the moment full system replacement surgery is panned but has not been scheduled.
 
Event Description
It was reported by a company representative that high impedance was observed at a follow-up appointment. The patient¿s generator was programmed off and patient was referred for x-rays. Additional information from the treating physician indicated the patient has been having seizures over the last months and often falls, which could attribute to trauma to the device. The last setting check was done in (b)(6) 2012 in which there was no diagnostic performed on the generator. At the moment, the patient is having cognitive changes in which it is noticed an "empty stare", but no increase in seizures. At the moment revision surgery is planned but has not been confirmed.
 
Manufacturer Narrative
Type of report corrected data; omitted on initial report, 30 day report.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2559768
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dennis100
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« Reply #36 on: June 19, 2019, 04:27:33 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/28/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient was experiencing an increase in seizures which was causing cognitive changes. The physician believed the cause for the increase in seizures was due to the patient not being able to swipe the vns magnet and the battery being implanted for so many years. However it was noted that the battery indicator was green, indicating it was still functioning. The patient was referred for a generator replacement however no surgical interventions are known to have occurred to date.
 
Event Description
The patient underwent surgery to have the vns generator replaced prophylactically. The explanted generator was received and is pending product analysis.
 
Manufacturer Narrative
 
Event Description
Analysis was completed on the explanted generator. Upon receipt the generator would interrogate normally and the battery indicator was eri = no, indicating that the device's battery was not low. The reed switch, which activates stimulation when the vns magnet is swiped, was tested and showed to be functioning to specification. The output signal of the generator was monitored for more than 24 hrs, while the generator was placed in a simulated body temperature environment. The results showed no signs of variation in the generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The device performed to functional specification.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6805604
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