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dennis100
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« on: July 07, 2017, 01:41:01 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/01/2013
Event Type  Injury   
Event Description
A physician reported that a patient was experiencing a new seizure type that began in 2013 and lasted until 2015. The physician believed the onset of the tonic-clonic seizures was possibly related to vns stimulation. A review of the available programming and diagnostic history revealed that the patient's device was working as intended while the new seizure type was present. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6676948
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dennis100
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« Reply #1 on: July 07, 2017, 01:41:40 AM »


Model Number 103
Device Problem No Known Device Problem
Event Date 01/01/2015
Event Type  Injury   
Event Description
It was reported that a patient had begun experiencing a new seizure type. The patient's new seizure type was described as complex partial seizures with secondary tonic-clonic. The patient's treating physician stated the new seizure type was possibly related to the vns stimulation and the event had not resolved. No change in settings had occurred. A review of the available diagnostic data showed that the device had been functioning as intended throughout the known programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6676372
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dennis100
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« Reply #2 on: July 09, 2017, 02:10:41 AM »

Model Number 102
Event Date 11/09/2010
Event Type  Injury   
Event Description
It was reported that the patient was implanted on (b)(6), 2010, after which she fell into a status of epilepticus with complex partial seizure (stimulation not turned on at that time), which she had not experienced before. Due to this condition, the patient has been in an intensive care unit and has received aed on high dose since (b)(6), 2010. The patient stabilized, but remained in the icu as of (b)(6), 2010, and the stimulation has been turned on. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1936649
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dennis100
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« Reply #3 on: July 13, 2017, 03:22:24 AM »

Model Number 103
Event Date 11/03/2010
Event Type  Injury   
Event Description
Reporter indicated that a vns patient had developed a new seizure type and has suffered injury with falling from the seizures. The reporter feels the new seizures are due to the vns being adjusted. Attempts to the treating neurologist for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1914038
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dennis100
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« Reply #4 on: July 15, 2017, 06:19:23 AM »

Model Number 103
Event Date 03/23/2010
Event Type  Injury   
Event Description
It was initially reported by the treating physician that the vns pt's device was turned on (b)(6) 2010, with the pt having a dramatic improvement in her grand mal seizures but since stimulation, the pt has developed what appears to be myoclonic seizures. The physician says the myoclonic seizures act like an aura that proceeds a generalized seizure. The family swipes the magnet when they note the pt is having a myoclonic seizure and the magnet stimulation aborts the generalized seizure. The family reported that one day the pt started having the myoclonic seizure and they couldn't find the magnet and the seizure progressed to a generalized seizure. The physician is planning on doing an eeg to confirm the new seizure type. Good faith attempts to obtain additional info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1959483
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dennis100
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« Reply #5 on: July 15, 2017, 06:20:12 AM »

Event Type  Injury   
Event Description
It was reported in the abstract for article entitled "effects of vagus nerve stimulation on electrocorticography" by kenichi usami, et. Al. That the pt experienced some reduction of seizure frequency and severity after one yr with vns. However, the pt also began experiencing "drop attacks" which had not been seen before. The pt subsequently underwent a total callosotomy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1959460
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dennis100
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« Reply #6 on: August 06, 2017, 01:24:17 AM »

Model Number 102
Event Date 01/20/2011
Event Type  Injury   
Event Description
It was reported by a neurologist via clinic notes that a vns pt had a variable seizure control on (b)(6) 2011. Pt also reported a new type of seizure episode where he could not move for a few seconds which occurred about once a week. The vns diagnostics were within normal limits on (b)(6) 2011. On (b)(6) 2011, the pt reported that this whole body "freezes" and he remains stiff for approx 30 seconds to one minute (exact duration is unk). These events occur primarily at night about twice per day. The physician does not know about the exact cause of pt's body freeze but believe that these episodes are either sensory or motor related. Pt has not tried the vns magnet during these events. During the examination on (b)(6) 2011, the physician could ot communication with pt's device and believed that the generator was at end of service. Mfr battery life calculation resulted in negative battery life indicating end of service. The pt will likely have a revision surgery. Attempts for additional info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2236541
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dennis100
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« Reply #7 on: August 16, 2017, 04:21:32 AM »

Model Number 103
Event Date 01/01/2008
Event Type  Injury   
Event Description
During a retrospective study of a multi-center pt record review for pts previously implanted in (b)(6), it was indicated that the pt was noted as having a "new seizure type - partial" at the 1-year f/u. The mfr's programming history database was reviewed, which indicated that the pt's last known diagnostics were within normal limits. Good faith attempts have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2237082
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dennis100
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« Reply #8 on: August 19, 2017, 02:52:09 AM »

Model Number 104
Event Date 02/01/2011
Event Type  Malfunction   
Event Description
It was reported via clinic notes received dated (b)(6) 2011 that the patient had recently been experiencing a new seizure type described as facial flushing, stiffening, and then shaking of all of her extremities lasting 15 to 30 seconds. Diagnostics of the patient's vns indicate normal device function. It was noted that the patient's parents were pleased with the patient's seizure control. No interventions were taken in response to the change in seizures. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2314934
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dennis100
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« Reply #9 on: August 19, 2017, 02:53:09 AM »

Model Number 103
Event Date 10/06/2011
Event Type  Injury   
Event Description
It was reported that the pt had been experiencing an increase in seizures a couple months after having his generator replaced prophylactically. It was later found that the pt has been experiencing gran mal seizures which the pt has not had before. The pt's mother indicated that the pt has switched neurologists shortly following generator replacement. The pt's previous physician started the pt on depakote some time after generator replacement. Attempts for further information are in progress.
 
Event Description
Attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was received indicating that the patient was referred to a surgeon for evaluation; however, the vns has not been evaluated to determine proper device function. The patient's "seizure status is better" after being placed on clonopin. It is unknown if the patient's vns settings are at the therapeutic settings programmed prior to replacement. No interventions appear to be scheduled at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2301696
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dennis100
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« Reply #10 on: August 20, 2017, 07:54:23 AM »

Model Number 300-20
Event Date 06/01/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure suspected.
 
Event Description
It was reported that the vns pt would be having his vns lead and generator replaced due to high impedance. Clinic notes were received indicating that the pt has been experiencing an increase in seizures and experiencing a new seizure type involving "cessation of activity and upward eye deviation. " attempts for further information have been unsuccessful to date. Surgery to replace the pt's generator is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2325383

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dennis100
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« Reply #11 on: August 23, 2017, 03:59:49 AM »

Model Number 104
Event Date 12/01/2010
Event Type  Injury   
Event Description
Additional information was received indicating that any increase in seizures that the patient was experiencing prior to the replacement has now returned to their vns baseline. Product analysis on the generator was completed. The reported low battery conditions were duplicated in the pa lab. Results of diagnostic testing indicate that the battery status is at a neos=yes condition. The battery was found to be partially depleted. There were no conditions found during product analysis of the generator that would affect the generator performance.
 
Event Description
It was reported through clinic notes received on (b)(4) 2011 that the patient had developed a new seizure type in (b)(6) 2010, had experienced two prolonged seizures which he was hospitalized for on (b)(6) 2011, and was experiencing an increase in seizures on (b)(6) 2011. It was reported that the patient had experienced 16 seizures in the last month compared to 6 seizures a month prior to that appointment. During the patient's follow up visit on (b)(6) 2011, it was reported that the patient's generator was showing the intensified follow-up indicator. The patient was referred for and underwent a generator replacement procedure on (b)(6) 2011 due to the ifi flag and the increase in seizures. The explanted generator has been returned, however, product analysis has not yet been complete. Attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was received from the patient's treating neurologist indicating that the reported new seizure type was thought to be non-epileptic by an epileptologist. The prolonged seizures were part of the patient's usual seizure pattern, and the reported increase in seizures was above the patient's pre-vns baseline. The neurologist indicated; however, that she did not feel that any of these events were related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2335944
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dennis100
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« Reply #12 on: September 01, 2017, 01:37:30 AM »

Model Number 102
Event Date 03/19/2009
Event Type  Injury   
Event Description
Attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
It was reported in clinic notes received on 12/16/2011, that the patient experienced an increase in seizures and a change in seizure type on (b)(6) 2009. It was indicated that the patient had developed staring seizures, right hand tremors, and seemed pale and dazed for up to 30-40 seconds. The notes also stated that the patient had an increase in myoclonic partial seizures. The patient's vns settings were adjusted at that appointment. At the patient's next appointment on (b)(6) 2009, it was indicated that the patient was doing much better. It was also indicated on (b)(6) 2009 that the patient was having mood changes and an increase in seizures. Attempts for additional information are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2414978
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dennis100
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« Reply #13 on: September 05, 2017, 02:02:55 AM »

Model Number 102
Event Date 03/01/2010
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported through clinic notes dated (b)(6) 2011, received on (b)(6) 2012, that the patient had an increase in seizures after a prolonged remission. It was reported that the patient had 3 seizures in one week. The seizures were described as generalized stiffening while remaining conscious. The patient had not reported these seizure types previously and no medication changes or triggering factors were identified. It was also indicated that an association between the new seizure type and psychogenic nonepileptic seizures cannot be ruled out. Attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was received indicating that the increased seizures were believed to be related to the device nearing end of service. The patient has since been referred for a prophylactic replacement. The increase was back to the patient's pre-vns baseline frequency and all of the patient's seizure types have increased. There were no causal or contributory programming changes, medication changes, or other external factors precede the onset of the increase/new seizure type. Diagnostics were said to be normal, however specific results were not provided. No additional information was received. Revision is likely but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2451482
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dennis100
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« Reply #14 on: September 07, 2017, 03:27:53 AM »

Model Number 106
Event Date 08/01/2016
Event Type Injury
Event Description
It was reported that the patient had been experiencing whole body shakes since undergoing vns generator replacement surgery. The caregiver suspected these events were seizures which would be a new seizure type for the patient. It was reported that these body shake events do not occur with stimulation. The patient was seen by the physician after the caregiver reported the body shake events to the manufacturer. However the caregiver did not report these events to the physician and the physician was unaware of the body shake events. Therefore, the physician could not determine if these events were seizures and he could not assess their relationship to vns therapy. It was noted during the visit with the physician that diagnostics were ok and that the generator's settings are still being titrated up since implant. Manufacturing records for the generator was reviewed and found that it passed quality control inspection. No additional relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6002867
« Last Edit: December 31, 2017, 02:39:25 AM by dennis100 » Logged
dennis100
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« Reply #15 on: September 15, 2017, 01:52:32 AM »

Model Number 103
Event Date 04/12/2012
Event Type  Malfunction   
Manufacturer Narrative

Manufacturer Narrative
Additional information received indicated that the nurse may attribute the patient's increased seizures to the model 103 generator. As such, the type of reportable event is now considered to be a malfunction. (b)(4).
 
Event Description
A nurse reported on (b)(6) 2012, that a patient, who was implanted with vns on (b)(6) 2012, had an increase in seizures and new seizure type when the output current was increased from 0. 5ma to 0. 75ma. The patient's parents reported that they taped the magnet on the generator, and the seizures stopped. The nurse turned the output current back to 0. 5ma a few weeks prior. The plan was to try and titrate the output current up again. If the seizures got worse again, the nurse planned on lowering the current again and try it for another month. The patient's regular seizures were reportedly now back at pre-vns baseline level. The only difference in the patient's seizures was the new type of seizure. No causal or contributory or external factors preceded the onset of the events. Follow up with the nurse revealed that the device was programmed from 0. 75ma to 1. 0ma on (b)(6) 2012, and the caregiver reports the increased seizures occurred that evening, and the seizure semiology was reported to be known. It is believed that the patient has experienced complex partial and secondary generalized seizures since vns implant. However, it is unclear if both of these seizures types are new for the patient since implant. In addition, the date in which the new seizure type was first observed is unclear with the information provided. Attempts for additional information have been unsuccessful to date.
 
Event Description
It was reported that the nurse believed that there may be an issue with the model 103 generators because she has another vns patient who has experienced an increase in seizures when programming settings were changed, as reported in manufacturer report number: 1644487-2012-01583. The nurse believes the two patient's increased seizures are acute situations. Follow up with the nurse revealed that she was mistaken regarding some of the reports, and it is unclear if she still suspects an issue with the model 103 generators. Attempts for clarification have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2565092
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dennis100
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« Reply #16 on: September 17, 2017, 02:24:15 AM »

Model Number 103
Event Date 05/01/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Reporter indicated vns diagnostics for the patient's vns generator were within normal limits on (b)(6) 2012 with 2885 ohms, and the generator was not at end of service. The output current was increased from 1ma to 2ma at that time. The patient's medications were increased in (b)(6) 2012 to allow for greater seizure control, but the reporter felt the seizure increase was due to a depleting vns battery. The patient has also been experiencing behavioral issues since (b)(6) 2012. The patient was referred for generator replacement to preclude a serious injury that may result from either the increased seizures or behavioral issues if no improvement was seen. The patient had generator replacement surgery performed on (b)(6) 2012. The explanted generator has been returned and is pending analysis. Paperwork returned with the generator indicated the replacement was prophylactic.
 
Event Description
It was reported through clinic notes dated (b)(6) 2012 that patient was experiencing a new seizure variation tonic posturing then bends forward at waist then back up for the past 3 weeks. The patient's mother indicated that this was the worst seizure type seen in 20 years. Follow-up was made with the treating physician and it was indicated that upon checking function of vns, battery icon showed 25% life remaining. The new seizure was believed to be associated with low battery life. Additionally, increased activity could be related to decrease in output current on (b)(6) 2012 to maximize magnet benefit. At the moment, the patient has been referred to neurosurgery for battery replacement. Diagnostics at the office visit of (b)(6) 2012 indicated ok/2778/ok/no after a decrease in output current. However, diagnostics from the previous office visit ((b)(6) 2012) indicated eos=yes.

Event Description
Product analysis was completed on the returned vns generator. The generator was found to be at vbat

Event Description
Reporter indicated the patient's seizures had improved since the vns was replaced on (b)(6) 2012, and that the new seizure type has completely resolved since the vns replacement. The new seizure type was described as tonic posturing with bending forward, nostrils sucked in, and mouth clenched. The mother states the patient's seizures have improved since the replacement. The reporter stated vns has helped the patient's behavior as well.
 
Event Description
All further attempts to the reporter for information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2629599

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dennis100
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« Reply #17 on: September 22, 2017, 01:19:38 AM »

Model Number 102
Event Date 12/01/2010
Event Type  Injury   
Event Description
Additional information was received from the physician indicating the patient's different seizure type was first noted on (b)(6) 2011. When asked, the physician attributed the different type of seizure to "different type of seizure. " the toleration issues were clarified to be coughing. No trauma or manipulation was believed to have occurred. The physician indicated she was able to titrate the patient up slowly and he was able to tolerate the changes in settings well. No programming or medication changes were believed to have caused or contributed the tolerability or seizures. Diagnostic results were requested but not provided.
 
Manufacturer Narrative

Event Description
It was reported via clinic notes received dated (b)(6) 2012, that the vns patient noted at a previous office visit on (b)(6) 2011, that he had experienced a "different type of seizure" involving collapsing without warning. One such collapse was noted as occurring in (b)(6) 2010, that required the patient to go to the emergency room and resulted in a significant hematoma in his neck. The patient had another one of these episodes in (b)(6) 2011. The notes from (b)(6) 2011, indicated that the patient had not noticed any improvement from vns therapy however another note dated (b)(6) 2012, indicated "now doing well with higher stimulations" regarding the vns. The note dated (b)(6) 2012, indicated the patient "could not tolerate higher stimulus" however the patient's seizure frequency was noted as 3 seizures per month at that time versus 4-5 seizures per month indicated on the note regarding the visit on (b)(6) 2011. The patient was noted as being compliant with medications. Last known diagnostics were taken on (b)(6) 2008. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2720243

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dennis100
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« Reply #18 on: September 28, 2017, 01:12:51 AM »

Model Number 104
Event Date 09/11/2012
Event Type  Injury   
Event Description
Product analysis was completed on the returned generator. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The battery is partially depleted, 2. 649 volts (at ifi) as measured during completion of test parameter (measured diagvbat) of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 107. 769% of the battery had been consumed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
The patient had a prophylactic replacement of their generator and it has been returned and analysis is pending completion.
 
Event Description
Clinic notes were received for review reporting that a vns patient was hospitalized for a seizure. Reported that the patient was an (b)(6) male who presented to the emergency department after a day of seizures that are "different than normal". His mother reported via the received notes at her childs last tonic clonic seizure was (b)(6) 2012 am around 6:30 and lasted 10-15 seconds. Later that morning he was having multiple episodes of "humming like casper" and "gazing into space" which were often accompanied by him losing tone in the upper half of his body and bending over. The patient the same day went to take a shower and was found in the tub head down. The patient's mother reported that they do not regularly use the' patient's vns, don't have the magnet around (reportedly at patient's school). The patient's mother also does not like giving her child diastat because it knocks him out and it "takes him 2-3 days" to recover from a dose. The patient had one recent drug change, his psychiatrist switched his risperidone from 0,5 mg bid, to 1 mg qhs. No recent stressors noted. No missed medications, no sick contacts. The patient had been sick two weeks earlier with vomiting and diarrhea. No treatment was sought for that. He additionally had an elevated blood pressure for him of 147/88 possibly related to their fall. They will keep monitoring for head injury signs and symptoms. The patient does have frequent absence-like seizures. Thus far no further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2772437

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« Reply #19 on: September 29, 2017, 02:01:37 AM »

Event Date 08/01/2010
Event Type  Injury   
Event Description
It was reported by the vns patient that she experiences "coma seizures" that involve her "having continual seizures that will make her go into a coma. " the patient was unable to clarify if this was status epilepticus. These events have lasted from one night to three weeks. She indicated these events began occurring 9 months following vns implant and the last event has not occurred in about a year. This has reportedly only occurred a few times. A physician at a hospital indicated at least one of the events may have been related to the patient missing a dose of xanax. The patient also indicated that she is experiencing continuous pain at the generator site. She stated vns has improved her daily seizure control. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2818118

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« Reply #20 on: September 30, 2017, 12:37:22 AM »

Model Number 103
Event Date 08/23/2012
Event Type  Injury   
Event Description
Manufacturer follow up with the explanting hospital initially indicated the explanted vns generator was not available, but it was later returned on (b)(6) 2013 and is pending analysis. A manufacturer's implant card was also received indicating the reason for generator replacement was due to battery depletion. Diagnostics with the new generator and resident lead were within normal limits.
 
Event Description
Analysis of the vns generator was completed. No anomalies were identified, and the generator performed per specifications. The generator was not at end of service. Manufacturer follow-up with the reporter revealed the patient's seizures have improved since the vns generator was replaced.
 
Event Description
Reporter indicated that a patient was having increased seizures and a new seizure type of drop seizures. The vns was noted to be at end of service, but was still functioning as intended. The increased seizures are felt to be due to the generator nearing end of service, and the level of the seizure increase and seizure type is not known. The cause of the new seizure type (drop seizures) is not known. The patient had vns generator replacement surgery performed on (b)(6) 2012. Attempts for additional information and return of the explanted generator are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2887869
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« Reply #21 on: September 30, 2017, 12:37:57 AM »

Model Number 103
Event Date 08/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, the patient reported that she was experiencing a change in seizure pattern in which she was having new seizure types and nocturnal seizures. It is unknown what the relationship of the change in seizure pattern is to vns therapy. In addition, it was reported that the patient went to the hospital the month prior due to concern about her neck bulging with stimulation. The emergency room physician ordered a ct scan of the neck. Per the patient, the emergency room physician stated that it appears the lead is 'on the main vein. ' the patient was instructed to temporarily stop stimulation using the magnet and see the primary vns physician with ct scan results. Per the patient, the vns physician disabled the device and stated that he thought the device was on high settings. The physician recommended the patient follow up with her surgeon; however, the patient does not have the resources to do so at this time. In addition, the patient has also reported experiencing a pain in the neck area, extreme voice hoarseness with stimulation, painful stimulation, difficulty breathing with stimulation, and loss of gross mobility with much of stimulation. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2887104
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dennis100
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« Reply #22 on: October 01, 2017, 12:23:22 AM »

Model Number 102
Event Date 04/08/2012
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2012 indicate that the patient had about ten seizures per day, which was pretty good control for her. Clinic notes dated (b)(6) 2012 additionally noted that the physician was concerned about the recent episodes the patient had. The physician stated that the patient's mother told him that the patient is out of it for 45 minutes and can sleep up to 18 hours. Apparently a teacher at school thought the patient was faking this although the physician stated it is unclear to him how the patient could fake that length of sleeping. Per the physician, the patient does not typically have this type of seizure and this is a change for her, so before making medication adjustments, it was planned to take a 24 hours video eeg to see if there aware any changes from her last eeg which was several years ago. Clinic notes dated (b)(6) 2012 indicate that the patient was weaned off of topomax.
 
Event Description
Clinic notes dated (b)(6) 2012 found that the patient had experienced "four episodes of limpness and unresponsiveness lasting up to 45 minutes," which was "completely atypical for her. " the patient's mother confirmed the change in seizure pattern on (b)(6) 2012 as she reported that the patient was experiencing incontinence during seizures which the patient had not prior to vns in 2007, and that recently the patient became unresponsive while experiencing seizures. The patient's mother also reported that the patient's seizures had increased in frequency; however, she stated that this frequency was the same frequency level the patient had prior to vns. The patient's mother reported that the patient had been to the emergency room three times in the past few months and that the "unresponsive" behavior started on (b)(6) 2012 while the incontinence had been occurring for the past eight months. Clinic notes dated (b)(6) 2012 further detail the patient's change in seizure pattern. The patient's unresponsiveness lasts 4-5 minutes. The patient also experiences clusters of eye rolling up fluttering, which leads to difficulty seeing. Nine of these events were experienced on (b)(6) 2012 from 0650 to 0745, and three more events were experienced while the patient was in school. In addition, it was noted on (b)(6) 2012 that the patient is in pain when using the magnet. It is unknown where this pain is located and how long it has been occurring. Clinic notes dated (b)(6) 2012 verify that the patient's seizures had become worse and that she was in the hospital that day due to the number of seizures. The physician states in the notes that he believes the patient needs a prophylactic battery replacement as the battery is greater than six years old and the rapid cycling settings the patient is set on is using up the battery more quickly. Notes dated (b)(6) 2012 again state that a vns battery change is needed, and the patient underwent replacement surgery on (b)(6) 2012. Attempts have been made for additional information; however, they have been unsuccessful. Attempts will be made for product return so product analysis can be performed. No additional information is available.
 
Event Description
Follow up with the physician's office found that the patient's device was turned back on again on the same day of the surgery - (b)(6) 2012. The explanted device has been discarded/destroyed. No additional information has been provided.
 
Manufacturer Narrative
Date of event, corrected data: incorrect date inadvertently written in initial mdr. Describe event or problem, corrected data: information from clinic notes inadvertently not included in initial mdr. Relevant tests/laboratory data, including dates, corrected data: information inadvertently not included in initial mdr.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2858364
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dennis100
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« Reply #23 on: October 04, 2017, 12:16:28 AM »

Model Number 103
Event Date 12/14/2012
Event Type  Injury   
Event Description
Product analysis on the explanted generator was completed on (b)(4)2013. In the pa lab, the device output signal was monitored for more than (b)(4), while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 777 volts as measured during completion of the final electrical test, shows an ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative

Event Description
On (b)(6) 2013 clinic notes were received from a vns treating physician. Review of the clinic notes dated (b)(6) 2012 indicated that the patient has been experiencing an increase in seizures along with an increase in seizure intensity. It was noted that the patient has 4-6 gtcs daily and they have increased around sleep and with menses; prior to that the patient had only absence seizures. The patient's settings were: output=1. 5ma/frequency=30hz/pulse width=500usec/on time=30ec/off time=3min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=500usec. The patient was referred for surgery due to an unknown reason. Although surgery is likely, it has not occurred to date. Good faith attempts for further information from the physician have been unsuccessful.
 
Event Description
On (b)(6) 2013 the explanted generator was received for product analysis. Product analysis is still underway and has not yet been completed.
 
Event Description
Additional information was received when it was discovered that the patient underwent a battery replacement surgery on (b)(6) 2013. It was reported that the explanted generator would be returned to the manufacturer for product analysis, however it has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2979716

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dennis100
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« Reply #24 on: October 06, 2017, 01:51:38 AM »

Model Number 101
Event Date 10/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2013 it was reported that the vns patient wants to have the vns explanted because her generator protrudes and it bothers her. The patient was seen on (b)(6) 2013 and they were unable to interrogate the patient's vns likely due to end of service. The last time the patient was seen was about a year ago and they were able to interrogate her vns without any problems. The patient had a new seizure type in (b)(6) 2012 which the patient reports that she has never had before. It was later reported that the patient now wants the vns replaced instead of explanted. Good faith attempts for further information from the physician have been unsuccessful. A battery life calculation was performed which showed 1. 73 years remaining until eri=yes. Although surgery is likely, it has not occurred to date.
 
Event Description
Additional information was received on (b)(4) 2013 when the physician provided clinic notes from the (b)(6) 2013 visit. It was noted that currently the patient's seizures are fairly well controlled; she had a big seizure approximately 3 months ago. The patient is currently having small spells a few times a month, but the patient stated that this is the best seizure control she has had so far. Her vns has not been interrogated for the last several years (5+ years) and the patient's vns was interrogated that day and the settings were increased to achieve better seizure control. No further information was provided from the physician.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2947674
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dennis100
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« Reply #25 on: October 06, 2017, 01:52:24 AM »

Model Number 103
Event Date 01/06/2013
Event Type  Injury   
Event Description
An implant card was received on (b)(6) 2013 stating that the generator was explanted due to battery depletion. The generator was replaced with an m105 on (b)(6) 2013. Lead impedance was ok.
 
Event Description
New information was received which revealed that the generator was discarded. It was also noted that the patient's increase in seizures occurred when the vns generator was at end of service.
 
Manufacturer Narrative

Event Description
It was reported that the patient have had increase in seizures and new seizure types were noted. The physician noted the generator was at end of service, but it is not known what indicator was seen. Additional attempts to contact the physician for additional information are underway. Attempts for return of the vns generator are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2951038
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dennis100
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« Reply #26 on: October 06, 2017, 01:53:01 AM »

Model Number 103
Event Date 03/01/2012
Event Type  Injury   
Event Description
Reporter indicated the patient did have a new seizure type, but this was not reported by the parents until (b)(6) 2012. Onfi medication was started as an intervention. Nothing precipitated the change in seizure type. The seizure type was described as generalized tonic-clonic lasting 3-4 minutes, followed by sleeping 15-20 minutes. This was first reported on (b)(6) 2012 to occur twice a week, but at the (b)(6) 2012 office visit it was reported to occur "quite infrequent".
 
Manufacturer Narrative
(b)(4).
 
Event Description
Reporter indicated via clinic notes dated (b)(6) 2012 received to the manufacturer that a patient experienced a new onset seizure type of generalized tonic-clonic seizures in (b)(6) 2012. The seizures initially occurred 1-2 times per month, then increased to 1-2 times per week, and are currently occurring 2 times per week. The patient had vns generator replacement surgery performed on (b)(6) 2013 due to nearing end of service. Attempts for additional information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2950592
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dennis100
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« Reply #27 on: October 10, 2017, 02:40:21 AM »

Model Number 105
Event Date 02/27/2013
Event Type Injury
Manufacturer Narrative

Event Description
A vns treating physician reported that his patient was seen (b)(6) 2013 and the patient is having seizure clusters now but there is no increase in number of seizures. He also reports that patient recently had her first grand mal seizure. The patient's medications have been stable and the physician was wondering why her seizures have changed to clusters and reason for her first grand mal. The patient was set at 2. 25ma output current and he decreased her output to 1. 25ma (b)(6) 2013. Her off time was adjusted from 0. 3 to 0. 2. Good faith attempts have been made for further details and at this time no further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3012670
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dennis100
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« Reply #28 on: October 12, 2017, 01:03:09 AM »

Model Number 103
Event Date 06/01/2012
Event Type Injury
Event Description
The reporter indicated via clinic notes dated (b)(6) 2013 to the manufacturer that the vns patient had been experiencing different seizure types under normal stimulation. The patient experienced a total of three tonic-clonic seizures in (b)(6) 2012, for which there was no clear reason why they occurred. The patient experiences atonic seizures, starting in (b)(6) 2012, weekly. These are drop attacks and the patient falls down with loss of consciousness. The patient had generator replacement surgery performed on (b)(6) 2013 due to reported end of service. The explanted generator will not be returned from the hospital per the hospital's policy. All attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3121521
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dennis100
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« Reply #29 on: October 13, 2017, 11:09:58 PM »

Model Number 102
Event Date 05/20/2013
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2013 it was reported that the patient underwent prophylactic generator replacement that day. The explanted generator has not been returned for product analysis to date.

Event Description
The explanting facility discarded the explanted device; therefore, no analysis can be performed.

Event Description
A vns patient's mother called and reported that about a week ago around (b)(6) 2013 her child had a different seizure than ever before where he was confused during the seizure and she called ems but pt was not transported to the emergency room. Their seizures are still below baseline. The patient's last clinic visit prior to that date was (b)(6) 2013: clinic notes were received for review that reported. His seizures have been very well controlled with the vagus nerve stimulator which was implanted back in 2006, for almost one year, he did very well without recurrent seizures, but when he had l3-l4 laminectomy about 3 months ago, he had another seizure but since the last visit, he has been seizure fee. His vns was increased on his last visit. He's been tolerating the current dosage of medications which have not changed for a while. He did not have any significant side effects from the current settings of the vagus nerve stimulator. Good faith attempts are underway to determine the relationship of their change in seizure type to their vns device. Their device is not at end of battery life. The patient has been scheduled for a surgery consult for 6/25/2013. The outcome of the visit is pending. Unknown at this time if the patient will have their generator replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3191385
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