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Author Topic: Increase/Worsening of Seizures  (Read 532089 times)
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dennis100
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« Reply #3810 on: March 04, 2018, 01:44:59 AM »

Model Number 104
Event Date 05/31/2012
Event Type Injury
Event Description
On (b)(6) 2012, a patient's medical power of attorney reported that since this vns patient's battery change on (b)(6) 2012, the patient had been having seizures. The patient was hospitalized since (b)(6) 2012. The reporter was requesting that the patient's settings be lowered. On (b)(6) 2012, the patient's physician contacted a consultant and requested that changes be made to the patient's vns. The patient's settings were adjusted and diagnostics on the patient were performed with normal results. The physician was still uncertain about the cause of the seizures. On (b)(6) 2012, additional information was received indicating that the patient's seizure level was above the pre-vns baseline. The patient's petit and grand mal seizures had both increased.

Manufacturer Narrative
Relevant tests/laboratory data, including dates, corrected data: previously submitted mdr inadvertently omitted the battery status indicator from normal mode and system diagnostics dated (b)(4), 2012. This report is being submitted to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2643315
« Last Edit: March 11, 2018, 10:01:42 PM by dennis100 » Logged
dennis100
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« Reply #3811 on: March 08, 2018, 09:58:36 AM »

Model Number 102
Event Date 10/19/2010
Event Type Malfunction
Event Description
Reporter indicated a vns pt was having increased seizures. The vns is not end of service. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1908707
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dennis100
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« Reply #3812 on: March 09, 2018, 04:20:39 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 01/01/2018
Event Type Injury
Event Description
It was initially reported that this patient was having a generator replacement due to battery depletion. It was reported by the surgeon after surgery that the patient was also having an increase in seizures, prior to surgery which was evaluated by his neurologist. Interrogation of the patient's generator by the surgeon indicated an end of service condition.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7285177
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dennis100
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« Reply #3813 on: March 09, 2018, 04:21:32 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 01/17/2018
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by a patient¿s mother that the patient was sick and ever since then she has started turning her head to the left and is keeping her eye closed. She is worried there might be a nerve issue or something wrong with the vns and maybe the vns is not working properly. It was later reported by the patient¿s mother that she was in the icu. She had severe seizures and in a sedated coma to stop the seizures, and the relationship to vns was unknown. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7297582
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« Reply #3814 on: March 09, 2018, 04:22:57 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 02/05/2018
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported by the patient's mother that the patient was experiencing seizures daily when the typical rate was one seizure per week. Follow up with the physicians office revealed that there was no reference in the patient's notes to an increase in seizures at the most recent clinic visit, but it was mentioned that the seizure control was better than the last visit. It was reported that the patient's seizure frequency was marked down as two to three seizures a week. They were unable to provide a comparison to the pre-vns baseline frequency. The physician's office was unable to find any notation of vns diagnostics. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7304124
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« Reply #3815 on: March 09, 2018, 09:44:03 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 01/21/2018
Event Type Malfunction
Event Description
It was reported that the patient had four seizures in one day which was unusual for the patient. A week prior, the physician had made adjustments to the patient's vns. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7277598
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dennis100
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« Reply #3816 on: March 09, 2018, 01:29:01 PM »

Model Number 105
Device Problem No Known Device Problem
Event Date 01/09/2018
Event Type Malfunction
Event Description
Report received that a patient experienced an increase in seizures. Because of this, the staff of the patient's group home did not think the device was working the same way it did in the past. The patient was also reportedly non-verbal so the patient was unable to indicate whether stimulation was still perceived. A review of the battery life calculation indicated the generator battery had likely not reached end of service. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7238693
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« Reply #3817 on: March 09, 2018, 01:29:39 PM »

Device Problem No Known Device Problem
Event Type Malfunction
Event Description
It was reported that over the last year the patient's generalized tonic clonic and focal seizures had increased. The patient's seizures also weren't responding to the vns magnet as they had previously. The physician believes the increase could be related to the onset of puberty but is also concerned it could be related to the vns device not working properly despite the device seeming to be ok upon interrogation. The patient was referred to the surgeon for consult however there is no information regarding a potential surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7238219
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dennis100
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« Reply #3818 on: March 09, 2018, 01:30:20 PM »

Device Problem No Known Device Problem
Event Date 12/10/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
A research article was received that compared seizure outcome from early (<= 5 years of age) and late (> 5 years of age) implantation of vns in children. This report captures one patient's increase in seizures after vns implant. Per the article data, this patient experienced an increase in seizure rate from 300 seizures per month to 450 seizures per month. In addition, one patient in the study experienced a postoperative infection, captured in mfr. Report # 1644487-2018-00164. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7241144
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« Reply #3819 on: March 09, 2018, 01:31:03 PM »

Model Number 106
Device Problem No Known Device Problem
Event Date 06/08/2017
Event Type Injury
Event Description
It was reported by the patient's husband that the vns was giving the patient a lot of problems. The patient's autostim output current was previously disabled due to discomfort, but the patient continued to have discomfort. The representative stated that x-rays and the vns was previously examined by the physician and no malfunction or failure was identified with the device. Clinic notes were later received that indicated that the patient's seizures were worse since the current vns generator was implanted. It was noted that the patient had recently been taken off of one of her aeds. No relevant surgical intervention is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7244110
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« Reply #3820 on: March 09, 2018, 01:31:57 PM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/11/2013
Event Type Injury
Event Description
It was reported by a distributor that a patient¿s vns was explanted per the family¿s decision as the ¿patient continued with seizures despite control of programming¿. When making adjustments to the parameters the seizures were reported to have increased. The lead impedance was not known. The explanted devices have not been received by the manufacturer to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7274988
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dennis100
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« Reply #3821 on: March 10, 2018, 03:08:13 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/01/2018
Event Type Injury
Event Description
It was reported that the patient's seizures increased since vns settings were turned up at his previous appointment. Patient also has an ear infection (unrelated to vns) and so the physician is unclear if the seizures are related to settings increase or ear infection. The neurologist had changed epileptic medications since the increase in seizures. The neurologist later reported that the increased seizures is due to a combination of things and not related to vns itself. The neurologist wonders if the vns battery could be declining and plans to check the device during the patient's next visit.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7237457
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dennis100
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« Reply #3822 on: March 12, 2018, 01:54:46 AM »

Model Number 106
Device Problem No Known Device Problem
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was seen in clinic for a parameter change due to a change in seizure pattern. At the previous clinic visit, the generator's pulse width was increased. It was believed that the patient¿s seizures had gotten worse since the change in parameters. The treating physician decreased the pulse width back down to its previous setting. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6250988
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« Reply #3823 on: March 13, 2018, 01:55:12 AM »

Model Number 102
Event Date 02/01/2008
Event Type Injury
Event Description
It was reported to the manufacturer by the patient's mother that the patient has been experiencing dysphagia and dyspnea since an increase in settings of the generator. It was indicated that these episodes were followed by seizures. It was also indicated that this frequency of seizures was above pre-vns baseline. The relationship between the increase in seizures and vns therapy is unknown at this time. The patient was suggested to use the magnet during meals to avoid aspirating. Good faith attempts to obtain additional information regarding the reported events have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1244594
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« Reply #3824 on: March 14, 2018, 01:33:29 AM »

Model Number 102
Event Type  Injury   
Event Description
Reporter indicated that the pt had begun having an increase in seizure activity, and had been having more "head drops" which the mother feels is what happens when the generator battery is depleted. The treating neurologist stated that the generator was tested and showed the battery to be working properly at the time of the report. The pt has since undergone a generator replacement surgery which was stated as being due to end of service. The explanted generator has been returned to the manufacturer for analysis, but analysis is not yet complete. All attempts for further info from the treating physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1559818
« Last Edit: June 03, 2018, 07:39:36 AM by dennis100 » Logged
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« Reply #3825 on: March 15, 2018, 02:30:18 AM »

Model Number 102R
Event Date 08/17/2012
Event Type Injury
Event Description
It was reported via clinic notes received dated (b)(6) 2012 that the vns patient was experiencing a significant increase in seizures and is being referred for prophylactic vns replacement. The patient was noted as now averaging 1 to 4 seizures per day. Diagnostics taken on the day of the note indicated normal device function. The physician increased the vns output current to combat the seizures. The physician indicated she felt that although the generator was not indicating it was nearing end of service, she felt it may reach end of service over the next 6-12 months and referred the patient for prophylactic replacement. A previous note dated (b)(6) 2012 indicated that the patient's family felt the patient's seizure frequency was stable at that time. Surgery to replace the patient's generator occurred on (b)(6) 2012. A report was received on (b)(6) 2012 indicating the patient had passed away the previous night. The relationship of the death to the increased seizures, vns, and replacement surgery is unknown. The death will be addressed by manufacturer report # 1644487-2012-02394. Attempts for additional information have been unsuccessful to date. Attempts for the return of the explanted generator are in progress.

Manufacturer Narrative

Event Description
Additional information was received from the neurologist indicating the increase in seizures began in about (b)(6) 2012. The physician attributes the increased seizures to "adolescence, becoming less responsive to [anti-epileptic drugs], [and] vns battery nearing [end of life]. " the physician increased the patient's medications as intervention and referred the patient for vns generator replacement. The increase in seizures was noted as below the pre-vns baseline seizure frequency. All of the patient's seizure types were noted as increased. No medication changes, programming changes, or other external factors were believed to have caused or contributed to the increased seizures.

Event Description
Additional information was received indicating the explanted generator was likely discarded as the site indicated they could not locate it.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2753576
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« Reply #3826 on: March 16, 2018, 02:02:46 AM »

Model Number 103
Device Problem No Information
Event Date 08/15/2012
Event Type Death
Manufacturer Narrative
The initial mdr inadvertently did not include information which was available at the time the report was written. This information was included on the supplemental 01 report sent on (b)(4) 2012.

Event Description
Cause of death information obtained from the national death index was reviewed by the manufacturer which indicated that the patient's cause of death was epilepsy, unspecified. 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.

Event Description
Per the funeral home, the patient's device has likely been buried with the patient. The policy of illinois vital records is not to provide death certificates. No further information has been obtained.

Manufacturer Narrative

Event Description
It was reported that the patient passed away due to sudep per the physician. The physician indicated that he did not believe the death was related to vns. The patient was noted as dying at home in bed. The physician also indicated that the patient had been experiencing an increase in nocturnal seizures shortly prior to the passing. The patient had been recently prescribed clendomycin to treat an infection however the location of the infection and relationship to vns were not indicated. The physician indicated that there may have been a relationship between the increase in nocturnal seizures and the infection and/or medication. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2746060
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« Reply #3827 on: March 17, 2018, 01:42:36 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 05/31/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient believed that her vns was causing more seizures after her settings were increased most recently. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6727276
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« Reply #3828 on: March 20, 2018, 02:06:19 AM »

Model Number 102
Event Date 02/07/2012
Event Type Malfunction
Event Description
It was reported via clinic notes received for review that a vns patient was having seizures on clinic visit date (b)(6) 2012. Reported patient doing ok. Currently off vimpat. Doing about the same, still having some drops and the seizures which last about a minute. The patient gets a little cyanotic with these spells. On visit date (b)(6) 2012 the patient reported that he's been having more seizures. Over the prior 3-4 weeks he had been having more episodes of not breathing for over a minute and can be cyanotic. The patient was going to be referred to their surgeon for follow up. It is unknown the relationship of their seizures to the vns baseline and if this is a new seizure type for the patient. Thus far no further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2775951
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« Reply #3829 on: March 20, 2018, 02:07:06 AM »

Model Number 102
Event Date 09/16/2009
Event Type Injury
Event Description
Reporter indicated that the pt had her vns generator replaced because the battery was at end of service. The generator was replaced and returned for analysis. During analysis, it was found that the generator was not at end of service. Follow-up with the site indicated that the generator had been believed to be at end of service because the pt was experiencing an increase in seizures. Further attempts for information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1902354
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« Reply #3830 on: March 21, 2018, 03:32:55 AM »

Model Number 102
Device Problem Extrusion
Event Date 06/20/2008
Event Type Malfunction
Event Description
A vns patient reported that she began experiencing numerous issues with vns therapy since implantation including weight loss, continuous abdominal pain and painful stimulation. The patient indicated that she had attempted to inhibit vns stimulation by taping her vns therapy magnet to her chest, but this had only resulted in the initiation of magnet stimulation and added that she would be seeking surgical consult for device explantation. Additional information was received from the patient who reported that in addition to developing a new seizure type, her seizures have increased "a thousand fold" since implantation. The patient also indicated that her carotid artery had been cut during implant surgery and added that she has lost around "2/3rd of her body weight" since implantation without any changes in diet or exercise. The patient stated that due to this weight loss, her generator and lead are now visible under the skin. Follow up with the patient's implanting surgeon revealed that the patient's carotid artery had not been cut during her implant surgery and that she has actually only lost around (b) (6), since being implanted with her vns device. The surgeon indicated that he had agreed to remove the device at the patient's request and added that explant surgery would occur within the week. Device diagnostics were performed at the patient's recent surgical consult and reportedly confirmed proper device function. Good faith attempts to the patient's past and present treating vns therapy physicians for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1473053
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« Reply #3831 on: March 22, 2018, 12:54:30 AM »

Model Number 102R
Event Date 08/31/2012
Event Type Injury
Event Description
Additional information was received indicating generator replacement surgery has occurred. The explanted generator was returned and underwent analysis. The generator performed to specifications and no anomalies were found.

Manufacturer Narrative

Event Description
It was reported that the vns patient was being referred for prophylactic battery replacement and the patient was experiencing an increase in seizures. No further information was provided. Follow-up with the physician's office found the patient has been experiencing difficulty with medications however the relationship of this to the increased seizures was not specified. The site also indicated that the patient was being referred to a cardiologist for prolonged qt syndrome. The relationship of this syndrome to vns was not specified. The patient's vns was previously disabled on (b)(6) 2010, due to an unknown reason. It is unknown if the patient's vns has been re-enabled since then. Attempts for additional information have been unsuccessful to date. Surgery to replace the patient's generator is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2766296
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« Reply #3832 on: March 24, 2018, 02:17:20 AM »

Model Number MODEL 250
Event Date 10/16/2012
Event Type Malfunction
Event Description
It was reported by the vns patient, who visited the hospital due to an earache and increased seizures as noted in manufacturer report # 1644487-2012-03033, that a local physician indicated he could not use his handheld programming computer because it was not working. No vns dosing physician is known in the area to the manufacturer by the name provided by the patient. Follow-up with the hospital staff found they were also not aware of any local physician by the name provided. No further information is known to attempt follow-up.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2834658
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« Reply #3833 on: March 26, 2018, 01:08:35 AM »

Model Number 102
Event Date 01/01/2007
Event Type Injury
Event Description
It was reported on 08/11/2016 that the patient has been implanted since 2006 and received therapy until she felt that she was having an increase in seizures associated with stimulation and as a result had her vns device disabled. The patient saw another physician who saw that with the device disabled the patient continued to have seizures so he re-enabled the device at its lowest settings and saw that the device is at neos-yes. The programming history database was reviewed on 08/22/2016 for the m102 generator. History was available from date of implant (b)(6) 2006 through (adjusted date) (b)(6) 2015. It appears that the date of device disablement mentioned in this file was (b)(6) 2007 and there is no history suggesting the device was programmed back on as of (b)(6) 2015. Follow-up showed that the physician cannot confirm or deny the disablement date because he does not have those records. The physician that the patient still has not seen efficacy since it has been turned back on. To the best of his knowledge, the seizure increase was above baseline although he does not have the old records to confirm.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5921553
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« Reply #3834 on: March 27, 2018, 12:57:15 AM »

Model Number 304-20
Event Date 09/01/2012
Event Type Malfunction
Event Description
Programming history was reviewed. System diagnostics on (b)(6) 2012 were within normal limits. On (b)(6) 2012, the generator was disabled. The patient reportedly has increased daily attacks and still has a feeling of muscle contractions. These are, however, decreased in intensity. The programming system was determined to functioning well. The patient underwent surgery on (b)(6) 2013. The generator was tested, and the lead was checked for discontinuity. There were no abnormalities found. The neurosurgeon used insulation material for the generator and the lead. It is unknown if this affected the reported muscle contractions. Additional surgery may be likely but has not taken place.

Event Description
Surgery to replace the vns lead is planned, but has not occurred to date.

Event Description
Reporter indicated there had been no medication changes or vns programming changes, no trauma, and no manipulation of the vns. The patient has had no current increase in seizures. Diagnostics indicate normal function.

Event Description
During review of the programming history database, it was identified that the patient's device was programmed back on after the disablement and continued to operate as expected. The generator was later explanted due to battery depletion.

Manufacturer Narrative

Event Description
Reporter indicated the increased seizures were felt to be related to stress, and "it remains unclear if these would have been less had the generator been on".

Event Description
Reporter indicated initially that a 's vns generator was unable to be interrogated, and was stimulating continuously. The patient had physiology tests (evoked potential measurements) performed and it was concluded by the physiologist no therapy was being delivered, and there was an issue suspected with the lead. Reporter later indicated the patient was having a slight increase in seizures in (b)(6) 2012. The patient was also experiencing left arm muscle contractions with vns stimulation. Lowering the vns pulsewidth did not resolve the issue, and the vns was disabled. The muscle contractions continued with the vns disabled. Vns diagnostics tests indicated normal device function. It is suspected per the reporter there may be a break in the lead insulation, or possible a lead break. Surgery to replace the vns lead is likely. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2820407
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« Reply #3835 on: March 27, 2018, 12:57:56 AM »

Event Date 01/01/2013
Event Type Malfunction
Event Description
It was reported on (b)(6) 2015 that a patient was having more seizures in the last 2 years. The patient was advised to follow-up with the physician. He believes the output current is 1. 5ma. Attempts were made for more information; however, no further information was able to be provided by the patient's physician.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4673415
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« Reply #3836 on: March 28, 2018, 02:10:18 AM »

Model Number 102
Event Date 09/30/2010
Event Type Malfunction
Event Description
No further information has been attained.

Manufacturer Narrative
Type of report corrected data; omitted on initial report, 30 day report.

Event Description
It was reported by a physician that a vns patient experienced worsening of seizures due to unknown reason. At the moment the relationship of the increase in seizures to vns therapy is unknown. Attempts to obtain further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2614192
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« Reply #3837 on: March 30, 2018, 03:01:57 AM »

Model Number 103
Event Date 04/12/2011
Event Type Malfunction
Event Description
Reporter indicated a vns patient was having increased grand mal seizures. Attempts for further information from the patient's treating neurologist are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2101674
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« Reply #3838 on: April 02, 2018, 01:27:06 AM »

Event Date 11/19/2010
Event Type  Injury   
Event Description
It was reported that the pt had her settings turned down due to pain at the electrode site in her neck, down her back and in her arm and leg. She has also experienced an increase in seizures recently and the magnet has had no effect. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1938613
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« Reply #3839 on: April 05, 2018, 01:24:09 AM »

Model Number ASKU
Event Date 01/01/2009
Event Type  Death   
Event Description
The article titled " sudden unexpected death in epilepsy: experience from a tertiary epilepsy center in cyprus with review of the literature" was received by the manufacturer and reviewed. The patient died on the beach during the day.
 
Manufacturer Narrative
Corrected data: the previously submitted mdr inadvertently provided an incorrect event date.
 
Manufacturer Narrative

Event Description
A manuscript titled "efficacy of vagus nerve stimulation in intractable epilepsy patients in cyprus" was received by the manufacturer for review. The article discusses efficacy of vns over time, which was analyzed in 27 patients. Two patients died of sudden unexpected death in epilepsy (sudep). Date of death unknown and relationship to vns is unknown. The report of the other patient who died of sudden unexpected death in epilepsy (sudep) is captured in mfg report number: 1644487-2013-00104. Attempts for additional information have been unsuccessful to date. The report of one patient who developed an infection is captured in mfg report number: 1644487-2013-00102. The report of one patient who had vns explanted due to dysphagia associated with vns stimulation is captured in mfg report number: 1644487-2013-00103. The report of one focal patient who had worsening of seizures is reported in mfg report number: 1644487-2013-00101. The vns explant due to painful stimulation in the neck is captured in mfg report number: 1644487-2013-00100.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2903591
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