VNS Message Board

VNS DISCUSSIONS => Legislative Activism In Regards to VNS => Topic started by: dennis100 on July 07, 2017, 01:41:01 AM



Title: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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



Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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



Title: Re: New Seizure Type
Post by: dennis100 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



Title: Re: New Seizure Type
Post by: dennis100 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



Title: Re: New Seizure Type
Post by: dennis100 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



Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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



Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 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


Title: Re: New Seizure Type
Post by: dennis100 on October 13, 2017, 11:57:48 PM
Model Number 102R
Event Date 01/01/2007
Event Type Injury
Event Description
It was reported that the physician does not have any further information on the drop attack seizures that the patient experienced in 2007.

Manufacturer Narrative

Event Description
Clinic notes were received for review that report that the patient was having a new seizure type identified as drop attack seizure on (b)(6). Good faith attempts are underway for further details about the reported event. At the time of this reported event their generator was not at end of battery life. They have had this battery replaced and it was returned for analysis. Generator eos was confirmed based on the measured battery voltage. The ¿as received¿ settings indicated a 58% duty cycle. Based on module performance according to the functional specifications. The unit exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion. No condition was noted during the product analysis evaluation that would suggest any anomaly with the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3174676


Title: Re: New Seizure Type
Post by: dennis100 on October 16, 2017, 12:32:07 AM
Model Number 102
Event Date 04/01/2012
Event Type Injury
Manufacturer Narrative

Event Description
It was observed in the patient¿s clinic notes dated (b)(6) 2013 that the patient was experiencing a new and unusual seizure type and was referred for a generator replacement. The unusual seizure was followed by left sided weakness that last 1-2 hours with full recovery (most likely todd's paralysis). Work up including head ct, echo and "carotid us" were unremarkable. System diagnostics were performed and the device was not at end of service. However, it is believed that a warning message was observed during interrogation to replace the device as soon as possible. The patient's medication was increased, and no vns programming changes were made. Good faith attempts were made to the physician and it was later reported by the physician that the patient was experiencing an increase in seizures, not new and unusual seizure types. The patient¿s seizures improved since vns implantation initially then her seizures worsened. The physician stated that the patient was experiencing left side weakness in their body with a longer recovery time needed after the seizures took place. This event was first observed (b)(6) 2012. He is unsure at this time if the increase in seizure frequency is due to todd's paralysis or vns therapy. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the change in seizure type. The patient has been referred for a generator replacement, due to the message noted on the handheld during interrogation stating that the device should be replaced as soon as possible. Although surgery is likely, it has not occurred to date.

Event Description
On (b)(6) 2013, the patient underwent generator revision. The explanted generator was destroyed per hospital protocol.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3250578


Title: Re: New Seizure Type
Post by: dennis100 on October 19, 2017, 01:07:29 AM
Model Number 104
Event Date 06/03/2013
Event Type Malfunction
Event Description
On (b)(6) 2013, it was reported that this patient was referred for end of service generator revision and prophylactic lead revision. The patient¿s seizures were stronger. Clinic notes dated (b)(6) 2013 indicated that the patent¿s last seizures was on (b)(6) 2013. The patient has complex partial seizures with typical post-ictal duration of 2 minutes. The vns was noted to be not working, and the patient was referred due to worsening seizures. Notes dated (b)(6) 2013 indicated exacerbation of seizures, and phenytoin was added. The notes did not indicate that the generator was interrogated or adjusted at this appointment. Notes dated (b)(6) 2013 indicated no worsening of seizures with a post-ictal duration of 3 minutes. Follow-up showed that the patient was implanted with vns and now had more frequent seizures. On (b)(6) 2013, they checked the vns, and it was completely dead. The same programming system was used successfully with other patient¿s. The patient was using 3 heavy duty medications, and it was not controlling her seizures. After she was implanted with the vns the seizures got better. When the battery died she started having generalized seizures that she didn't have before. The physician attributed the increase seizures to the battery being at end of service. The patient was referred for revision. Surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3358054


Title: Re: New Seizure Type
Post by: dennis100 on October 20, 2017, 12:27:48 AM
Model Number 102
Event Date 01/01/2013
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2013 indicate that the patient has been experiencing a new type of seizure that is different than the patient's usual staring episodes. It was noted that the new events are more of confusional episodes, and have been occurring approximately 3 times per week. It was noted that the patient does not have any evident seizures prior to the confusional episodes. It was noted that the patient's mother describes the patient's eyes as glazed over and he is unresponsive for a few minutes. Following the episodes, the patient has a headache and may be agitated. The patient was referred for generator replacement. The patient underwent generator replacement on (b)(6) 2013. The generator was returned to device manufacturer for analysis on (b)(4) 2013. Analysis is underway, but has not yet been completed to date.

Manufacturer Narrative

Event Description
Further follow-up revealed that overall, the patient has been doing reasonably well after the generator replacement.

Event Description
The generator analysis was completed on (b)(6) 2013. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3336683


Title: Re: New Seizure Type
Post by: dennis100 on October 22, 2017, 01:26:42 AM
Model Number 102
Event Date 01/01/2013
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2013 note that the patient has a new type of seizure this year where his legs go out from under him and he will just fall backwards and convulse. The relationship of the new type of seizure to vns is unknown. Attempt to obtain additional information have been unsuccessful to date.

Event Description
The generator was returned for analysis on (b)(4) 2013. The returned product form indicated that the generator was explanted on (b)(6) 2013 due to prophylactic replacement. Attempts to obtain additional information have been unsuccessful to date. Analysis of the generator was completed on (b)(4) 2013. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3397235


Title: Re: New Seizure Type
Post by: dennis100 on October 24, 2017, 01:16:18 AM
Model Number 103
Event Date 09/23/2013
Event Type Injury
Event Description
On (b)(6), 2013, the patient reported that she saw the physician around (b)(6). The patient stated that the physician doubled her keppra dosage and left the vns settings the same. Following the change in medication, the patient experienced an increase in seizures and began having a new seizure type. The patient had two mini grand mal seizures and one grand mal seizure. The patient attributes the increase in seizures to the medication changes, but did not specifically comment on the relationship of the new seizure type to the medication changes or vns. No other information has been provided.

Manufacturer Narrative
Evaluation codes-conclusions, corrected data: based on the initial report, there is no allegation of a device failure as the adverse event is believed to be related to medication changes. This report is being submitted to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3528909


Title: Re: New Seizure Type
Post by: dennis100 on October 24, 2017, 01:17:06 AM
Model Number 250
Event Date 05/03/2010
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history confirmed reported settings.

Event Description
It was reported that a patient was seen in clinic and their vns was interrogated and showed 0. 25ma/10 hz. It was intended for the patient to be programmed to 1. 5ma/30/500/30/3 min off time. The patient event was discovered on (b)(6)2010. It is unk if another programming system was used to program the patient to these settings as not default settings. The patient was programmed back to their intended therapy. Around the time of their programming event, the patient was having an increase in seizures from weekly to daily when they were at unintended therapy. Their seizures had changed and involved left side stiffening and head turning to the left that lasted 30 seconds. Overall, in the past several months, it has been reported that their seizures have been slightly more frequent. Good faith attempts are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1774009


Title: Re: New Seizure Type
Post by: dennis100 on October 31, 2017, 03:05:17 AM
Model Number 103
Event Date 02/01/2014
Event Type Injury
Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
Clinic notes were received indicating that the vns patient reported having an increase in seizures during an office visit on (b)(6) 2014. The increase in seizures is believed to be below pre-vns baseline levels. The patient was also experiencing new type of seizures consisting of muscle jerks. No issues with the patient's device were noted. No changes were made to the patient¿s device settings or medications during the office visit. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2014. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3894713


Title: Re: New Seizure Type
Post by: dennis100 on November 01, 2017, 01:27:37 AM
Model Number 105
Event Date 03/15/2013
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2014 note that since the patient's last visit on (b)(6) 2013, the patient has experienced an increase in seizures. It was noted that the patient's lamictal was increased and the patient's seizures improved. It was noted that the patient suffered a second increase in seizures in september 2013. It was noted that the lamictal was increased a second time; however, little improvement was seen. It was noted that the patient's seizures went from one seizure a month to 4-5 seizures a month. It was noted that the seizures tend to occur two weeks prior to her menses and either the week of or the week after her menses. The seizures often occur in pairs; she has a seizure in the evening around dinner time and one the following morning several hours after awakening. The notes indicate that the patient's seizures have changed in character since (b)(6) 2013. It was noted that the patient now becomes still and "falls like a tree, often on her face". It was noted that in the past her habitual seizures were described as staring and lip smacking. Initially, the increase and change in seizures was reported on mfr. Report # 1644487-2014-01499 as the increase and change in seizures were thought to be related to the high impedance event in this report. Information received on (b)(6) 2014 indicates that the increase and change in seizures occurred prior to the high impedance event. It is unknown if the increase in seizures is above the patient's pre-vns baseline frequency. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3963844


Title: Re: New Seizure Type
Post by: dennis100 on November 02, 2017, 01:23:28 AM
Model Number 103
Event Date 06/27/2011
Event Type Injury
Event Description
Clinic notes were received indicating that the vns patient went to the er and was admitted to the hospital on (b)(6) 2011. The patient had approximately 15 ¿episodes¿ that were different from the patient¿s normal seizure types. The episodes involved the patient chewing his tongue and losing consciousness. The patient was sleepier and more confused during the post ictal period. Since hospitalization, the patient had 1-2 seizures. Attempts for additional relevant information have been unsuccessful to date.

Event Description
On (b)(6) 2014 it was reported that the patient¿s physician retired and the patient was not seeing the other physician in the practice.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3942259


Title: Re: New Seizure Type
Post by: dennis100 on November 02, 2017, 01:24:11 AM
Model Number 302-20
Event Date 12/22/2011
Event Type Malfunction
Manufacturer Narrative
Analysis of programming and device diagnostic history performed. Device failure is suspected but cannot be confirmed.

Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned.

Event Description
It was initially reported that during prophylactic generator revision surgery on (b)(6) 2011, high lead impedance was obtained with the old generator and new generator therefore the lead was replaced. A company representative called back later and stated that originally, they thought the high lead impedance was due to the patient's output current being high (3. 5 ma) however with the new generator attached to the existing leads, high lead impedance was obtained therefore it was decided to replace the lead. The surgeon noticed that some of the helices did not appear to be attached to the nerve and were embedded. This portion of the lead was not removed as the surgeon did not feel it was safe to do so. Once the new lead and generator were implanted, the impedance value was 1350 ohms. Per the patient's mother, the patient started having more seizures (below baseline levels) and about a month ago, the patient had two grand mal seizures which had not occurred previously. The magnet also appeared to be less effective in aborting seizures. The explanted lead and generator were returned on 12/27/2011 and are currently undergoing device evaluation. Good faith attempts to obtain additional information have been unsuccessful to date. The patient¿s programming and device diagnostic history available in the in-house database were reviewed and no records of high lead impedance were found however the data was only available up to 12/07/2010.

Event Description
Additional information was received on (b)(4) 2012, where it was reported that there were no x-rays available to send to the manufacturer for review. There were no reports of trauma or manipulation. The relationship of the seizures to vns is unknown as well as the relationship of the seizures to vns as they did not detect any high lead impedance until the date of surgery. The patient was hospitalized due to the seizures and her medication was adjusted. The patient does have multiple types of seizures and all increased. It was difficult to assess whether any causal or contributory programming/medication changes or other external factors preceded the onset of the seizures. Product analysis of the explanted generator and lead was completed. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No 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 portion were performed, during the visual analysis, with no discontinuities identified. Note that since a portion of the lead assembly (body) including the electrode array section 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=2420397


Title: Re: New Seizure Type
Post by: dennis100 on November 03, 2017, 02:59:33 AM
Model Number 102R
Event Date 05/31/2014
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2014 note that the patient has experienced different seizures than she's had in the past. It was reported that the patient squinches her eyes closed prior to the spells and her eyes stay closed during. The patient appears to be fighting the spell and then will go into it. Her hands and arms will go forward and if she is laying down they go over her head and she will go limp. It was noted that these last only a few seconds and with in a few minutes she will be back to whatever she was doing. It was noted that the patient is generally incontinent with these spells and they do not occur when she is dancing. It was noted that the patient was seizure free from 01/2013 to 05/30/2014 and that the only change was diazepam was discontinued. Diazepam was resumed and the seizures have continued. The physician reported that the patient has experienced some increase in seizures with a loss of therapy, but that the seizures were not above pre-vns baseline frequency. It was reported that medication changes have helped. The physician does not believe that the discontinuation of diazepam was related to the seizures. The patient has been referred for prophylactic generator replacement. No known surgical intervention has been performed to date.

Manufacturer Narrative

Event Description
It was reported that the patient underwent prophylactic generator replacement. Pre-operative device diagnostics were within normal limits (neos - no). Device diagnostics with the new generator connected to the existing lead were within normal limits. The explanted generator was received for analysis. Analysis is underway, but has not been completed to date.

Event Description
Analysis of the generator was completed on 10/02/2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4027967


Title: Re: New Seizure Type
Post by: dennis100 on November 07, 2017, 01:58:43 AM
Model Number 102
Event Date 09/01/2014
Event Type Injury
Event Description
It was reported that the recently implanted vns patient had been experiencing an increase in seizures and a new seizure type for the past week. On (b)(6) 2014, the patient had a seizure that lasted for approximately 35 minutes and was taken to the er. The patient was given medication and admitted to the icu. The patient¿s seizures were determined to be non-epileptic but a new type for the patient. It was noted that vns had improved the patient¿s epileptic seizures. Follow-up revealed that the patient¿s device was tested and diagnostic results showed normal device function. The patient¿s device pulse width was decreased from 500usec to 250usec. The physician believed that the patient would have an anxiety attack that could trigger seizures if the patient felt stimulation from the device. With the adjustment to the device pulse width, the patient no longer felt stimulation and did not have another event since the adjustment. The patient¿s seizures have improved past pre-vns baseline levels.

Event Description
On 03/18/2015 it was reported that the patient¿s device was turned off on (b)(6) 2015. He was having ¿panic attacks¿ that would lead to seizures. The physician believes that the panic attacks may be brought on from the stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4131946


Title: Re: New Seizure Type
Post by: dennis100 on November 12, 2017, 03:22:51 AM
Model Number 304-20
Event Date 06/26/2012
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
An implant card was received on (b)(4) /2012. Diagnostics following the replacement were within normal limits. The explanted products were returned to the manufacturer on (b)(4) 2012. Analysis is not yet complete.

Manufacturer Narrative

Event Description
Analysis on the returned products has been completed. Analysis on the generator was completed on (b)(6) 2012. The results of bench diagnostic testing indicated the device was operating properly. 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. Analysis on the lead was completed on (b)(6) 2012. During the visual analysis the end of the connector pin quadfilar coil appeared to be broken. Scanning electron microscopy was performed on the connector pin quadfilar coil break and identified the area on one of the coil strands as having evidence of a stress induced fracture with mechanical damage and no pitting. Determination could not conclusively be made on the fracture mechanism. The remaining coil strands were identified as having evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. Secondary break lines and pitting were observed on the coil surface. Scanning electron microscopy was performed on a second connector ring quadfilar coil break and identified the area as having extensive pitting which prevented identification of the coil fracture type. The abraded openings and incision mark found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. Abraded openings were also identified in the inner tubing. 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. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Event Description
An article titled "twiddler syndrome with a twist: a cause of vagal nerve stimulator lead fracture" was received by the manufacturer which referenced a case report of a vns patient. ¿approximately 3 months after placement of the vagal nerve stimulator, the family noted subcutaneous protrusion of the device leads deep to the skin below the clavicle. Device function did not appear to be compromised and there was no change in the child¿s seizure frequency. A chest radiograph was obtained at that time and the vagal nerve stimulator leads were noted to be intact. Use of a compressive sling and snug-fitting clothing were advocated at that time. At 7 months after initial placement, the child¿s mother noted the onset of a new type of seizure. Interrogation of the vagal nerve stimulator revealed high impedance and chest radiograph showed twisting of the vagal nerve stimulator wires in the chest wall with fracture of the leads in the low neck. " x-rays were performed, and per the article, they showed there was longitudinal twisting of the vagal nerve stimulator leads in the chest wall and redundant portions of the wires are tightly looped/knotted in the chest wall just above the pulse generator. The device was deactivated and replaced one month later.

Event Description
It was reported that the patient's lead was fractured, confirmed through an x-ray. Additional information was received indicating that high impedance, greater than 10,000 ohms was observed during a follow up visit on (b)(6) 2012. At that time, the patient was referred for x-rays which showed a lead fracture. There was no manipulation or trauma to the device, and the x-rays will not be sent to the manufacturer for review. The lead was replaced on (b)(6) 2012. The explanted product has not been returned to the manufacturer to date.

Manufacturer Narrative
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=2669473


Title: Re: New Seizure Type
Post by: dennis100 on November 13, 2017, 02:45:35 AM
Model Number 103
Event Date 11/01/2014
Event Type Injury
Event Description
It was reported that the vns patient had been experiencing nocturnal seizures for the past two weeks. The patient stated that the seizures were convulsions and did not cause her to lose awareness. The patient also reported experiencing a change in seizure pattern; she stated she began having other feelings ¿inside¿ along with automatisms. It was noted that the magnet mode stimulation had been helpful in aborting the patient¿s seizures. The patient was instructed to activate magnet mode stimulation a few times before bedtime or during the day. The patient denied any life stressors but believed her ipad may have been triggering her seizures. The patient was instructed to visit with the following physician. Attempts for additional relevant information will be made.

Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient had been experiencing an increase in seizures and a new seizure type in november and (b)(6) of 2014. The seizures were attributed to stress during the holiday season. The patient was seen on (b)(6) 2015 and was doing well. The seizures had resolved and the patient¿s device was functioning well. There was no mention of potential issues with her ipad during the office visit and no further information was obtained as the patient was doing well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377912


Title: Re: New Seizure Type
Post by: dennis100 on November 15, 2017, 01:59:43 AM
Model Number 105
Event Date 10/01/2014
Event Type Injury
Manufacturer Narrative
This information was inadvertently left off of previous mfr. Report: suspect device udi: (b)(4).

Manufacturer Narrative

Event Description
It was reported that the patient experienced a new type of seizures in the form of clusters. It was also reported that the patient has experienced pain at the generator site. Clinic notes dated (b)(6) 2015 note that the patient's mother reports a significant number of complex absence / confusional episodes one every five days that last two days. The patient's fycompa was increased. It was noted that the patient complained of pain at the generator site when moving both arms. The patient was referred to surgeon for review and or revision of the vns regarding the pain. No additional relevant information has been received to date. No known surgical interventions have been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4632395


Title: Re: New Seizure Type
Post by: dennis100 on November 20, 2017, 03:16:34 AM
Model Number 104
Device Problem Device operates differently than expected
Event Date 06/01/2012
Event Type Injury
Event Description
Additional information received indicates that the provider is aware that the patient has grand mal seizures but does not believe the emergence of this seizure type to be related to the patient's vns device. The provider states that in addition to vns therapy the patient is being treated medically for all of her seizures types.

Event Description
The provider reported that the parent's reports of patient movements were considered psychogenic by another provider. Clinic notes were provided indicating that the events reported by the parents were ultimately determined to be abnormal behavioral movements and likely not seizures. Any actual seizures the patient was experiencing were attributed to the patient starting oral contraceptives.

Manufacturer Narrative

Event Description
It was reported that the vns patient began experiencing grand mal seizures approximately three years ago following initial vns implant. The patient had not experienced these types of seizures in the past. The patient¿s parent indicated that vns was effective in controlling her other types of seizures but not effective in controlling grand mal seizures. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4874395


Title: Re: New Seizure Type
Post by: dennis100 on November 21, 2017, 02:52:01 AM
Model Number 102
Device Problems Failure to deliver energy; Unexpected therapeutic results
Event Date 01/20/2015
Event Type Injury
Event Description
The patient underwent replacement surgery on (b)(6) 2015 due to prophylactic neos=no. The explanted generator was received for analysis on 10/23/2015. Analysis is currently underway but has not been completed to date.

Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
Product analysis for the m102 generator was completed and approved on 11/17/2015. Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an eri condition. Therefore, the electrical performance of the generator, as measured in the product analysis lab, will be used to conclude that no anomalies exist and the eri condition is an expected event. 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. In addition, a comprehensive automated electrical evaluation showed that 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.

Event Description
Clinic notes were received on (b)(6) 2015 for referral for battery replacement due to less efficacy being received from the device. Notes dated (b)(6) 2015 state that the patient has had few seizures and seizures are infrequent. The patient does not recall any seizures in the prior months. Follow-up showed that the patient is having an increase in seizure activity which is why less efficacy is thought to be received. The physician is concerned because her seizures have now included cluster seizures which is a new seizure type for the patient. It was noted that the patient doesn¿t feel stimulation as much and seizures have been aborted with magnet activation. There have been no change in medications leading to the increase in seizure activity. The patient can't tolerate vns settings beyond 1. 75ma. The physician opted for prophylactic replacement and increased her oral medications until surgery. Surgery is likely but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4848231


Title: Re: New Seizure Type
Post by: dennis100 on November 21, 2017, 02:53:22 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/05/2010
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported via (b)(6) that after vns implantation the patient's seizures went from partial to grand mal seizures. No additional relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem - corrected information: the information included in describe event or problem should have been included on the initial report as it had been received prior to submission of the initial report. Relevant tests - corrected information: the diagnostic information included in this section should have been included on the initial report.
 
Event Description
Additional information as received from the patient's medical professional who stated that they knew nothing about a change in seizure type for the patient. The patient's diagnostics were ok per the medical professional and her seizures were better as they were less and less severe.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7156962


Title: Re: New Seizure Type
Post by: dennis100 on November 22, 2017, 03:46:09 AM
Model Number 103
Event Date 12/30/2011
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received that the patient did not have any change in medications prior to their increased seizures. Titrations of therapy were made as follows. They were set at 1ma, 30hz, 500msec, 30sec, 5min on (b)(6) 2012. The physician assessed the stimulation may be too high, so he decreased the stimulation and the setting was 1ma, 25hz, 500msec, 30sec, 5min. The seizure control was still poor and their absence seizures increased, so the last parameter setting was changed (b)(6) 2012, which is 1. 25ma, 25hz, 500msec, 30sec, 5min. The seizure control has improved little bit since that time. They plan on monitoring the seizure control of this case. The final system diagnostic was at (b)(6) 2012, which result is normal. No further information has been attained.

Event Description
It was reported that the patient's seizures are progressively getting worse. Device diagnostics in september 2014 were within normal limits. Device settings options were discussed. No additional relevant information has been received to date.

Manufacturer Narrative
Adverse event or product problem: corrected data to serious injury. Type of reportable event - corrected data to serious injury.

Event Description
Our local partner in (b)(6) was contacted by a treating physician and it was reported that after a patient received their vns therapy on (b)(6) 2011, seizure control has become poor. The number of their average seizure attacks has increased from 4. 9 to 27. 4 /per day. Also, the seizure type has become more serious (for example: absence seizure attack combines silly laugher or shouting, it hasn¿t happened before vns implanted). Moreover, by family's concern and physician's experience, physician has changed the parameter setting frequently (2wks). The patient's seizure control has become worse. Good faith attempts are underway for further details about the reported events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2867808


Title: Re: New Seizure Type
Post by: dennis100 on November 26, 2017, 03:20:58 AM
Model Number 304-20
Device Problems Leak; Positioning Issue
Event Date 11/08/2014
Event Type Malfunction
Event Description
Follow-up was performed with the patient's neurologist. He was informed that product analysis found lead fractures and high impedance. He was not aware of any high impedance. System diagnostics were always within normal limits to his knowledge. The patient's mother was adamant that the device was not helping, but he did not agree. He programmed the device off in (b)(6) 2014 and left the magnet on. At that time the impedance was 3980 ohms. The patient had a lower seizure frequency about a year after implant. He disabled the device in (b)(6) 2014 to prepare for explant in 2015 as requested by the patient's mother. His protocol is to leave the device off for 6 months to determine whether vns is actually helping the patient. Within 6 months of disabling the device, the patient started to experience drop seizures, which he has never had before. The neurologist maintained that vns was clearly helping the patient as the patient did not have a new seizure type in 14 years until vns was programmed off. He did not think the patient hitting himself was in any way related to the high impedance which was found, as the patient was hitting himself as soon as the device was implanted.

Manufacturer Narrative

Event Description
It was reported that the vns patient underwent explant surgery on (b)(6) 2015 due to lack of efficacy. It was noted that the patient was developmental delayed and was hitting himself in the chest. The explanted generator and lead were returned to the manufacturer for analysis. Analysis of the lead identified that the connector pin had evidence of pitting and electro-etching on the surface. It was also found that the lead had not been fully inserted into the cavity of the generator. Lead discontinuity was found in both positive and negative quadfilar coils in the body region of the returned lead portions. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred on (b)(6) 2014, where the impedance value changed from high lead impedance to a normal limits range. Complete analysis of the generator was reported in manufacturer report # 1644487-2015-05615.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5029418


Title: Re: New Seizure Type
Post by: dennis100 on November 28, 2017, 02:39:37 AM
Model Number 103
Device Problem No Information
Event Date 07/21/2015
Event Type Injury
Event Description
A provider reported that a patient had experienced a new seizure type of greater than 10 minutes duration and that the patient was taken to the emergency room and hospitalized. It was reported that the patient had not experienced any seizures since the date of implant, (b)(6) 2015. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Follow up with the treating facility indicates that the patient was discharged home from the emergency room and did not receive any medical intervention while in the emergency room. The patient was instructed to follow up with his neurologist. Available programming history and diagnostic data was reviewed and no anomalies were noted. 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=4961275


Title: Re: New Seizure Type
Post by: dennis100 on November 29, 2017, 01:41:18 AM
Model Number 302-20
Event Date 03/29/2010
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected.
 
Event Description
It was initially reported that diagnostics performed indicated that high lead impedance was present, but specifics were not available. It was also mentioned by the parent that the magnet activations were no longer being perceived for approx two months prior. The pt's seizures were also said to be "different", but no further details have been made on the issue. X-rays were taken and sent to the mfr for analysis. No gross lead fractures or discontinuities were visualized on the portions of the lead body that could be assessed. However, the image quality in the neck area was poor, and there was a portion of the lead body located behind the generator that could not be assessed. Based on the x-rays received, there were no gross lead discontinuities or anomalies observed that could be contributing to the high lead impedance event. However, a led discontinuity cannot be ruled out on the portions of the lead that could not be fully assessed. Good faith attempts to obtain additional info have been unsuccessful to date. A review of the mfr's programming history database indicated that the last known diagnostics were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1686255


Title: Re: New Seizure Type
Post by: dennis100 on December 06, 2017, 02:45:38 AM
Model Number 105
Device Problem Device inoperable
Event Date 10/20/2015
Event Type Malfunction
Event Description
Additional information was received that the patient is able to inhibit stimulation by holding the magnet over the generator. Proper magnet swiping technique was verified and the magnet was not deep in the tissue or tilted. Troubleshooting revealed that the patient swiped her magnet and did feel stimulation, and the magnet swipe was registered upon interrogation. Information was received that the magnet is not often useful in aborting the patient's seizures because the patient normally cannot swipe the magnet in time, not suspected to be caused by a generator issue. It was reported that there are no longer any suspected issues with the patient's generator. No additional relevant information has been received to date.

Event Description
It was reported that vns was never efficacious per the mother. Per the mother, the seizures have never changed post-implant. No surgical intervention has occurred to date. No additional relevant information has been received to date.

Event Description
It was reported that the patient was experiencing shortness of breath with device stimulation. Device diagnostics were within normal limits and device settings were reduced. The physician believes the patient is overly sensitive to device stimulation. The patient was reported to be fine after device settings were reduced. It was reported by the patient's mother that they want the vns explanted due to painful stimulation in the neck, breathing difficulties with device stimulation during exertion. The mother reported that since the patient has had difficulty tolerating stimulation and they had not noticed any efficacy the device was disabled for three months. The device was then programmed back on to a very low setting. The stimulation is now tolerable. The mother reported that recently the patient has experienced a change in seizure type and has also had a transient ischemic attack which has contributed to her current state. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Manufacturer Narrative
Corrected data: this information was inadvertently left off of supplemental mfr. Report #01. Corrected data: "it was reported that the patient was experiencing shortness of breath with device stimulation. Device diagnostics were within normal limits and device settings were reduced. The physician believes the patient is overly sensitive to device stimulation. The patient was reported to be fine after device settings were reduced. " this information was inadvertently left off of supplemental mfr. Report #01.

Event Description
Follow-up with the surgeon's office revealed that the mother called their office in (b)(6) 2016 and wanted the patient to get a head mri due to increased headaches (with no allegation against vns). However, they had not seen the patient since 2014. The mother had mentioned wanting a mri and vns explant to the last treating physician's office. No surgical intervention has occurred to date. No additional relevant information has been received to date.

Event Description
It was reported that the patient's vns magnet mode is not thought to be functioning. It was reported that the patient cannot feel magnet activations and the magnet swipes are (b)(6) 2015 and one on (b)(6) 2015. The patient also experienced a cluster of seizures on (b)(6) 2015 that the magnet was not able to abort. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5216170


Title: Re: New Seizure Type
Post by: dennis100 on December 08, 2017, 03:29:28 AM
Model Number 103
Event Date 01/12/2015
Event Type Injury
Event Description
It was reported that the patient's vns battery is "shutting down". Additional information was received that the patient's battery was seen to be low (about 10%). Also, the patient has started having seizures a few weeks prior to visit on (b)(6) 2015 after previously being seizure free. These new seizures are also of a different type than previously, a "black-out seizure" where the patient does not recall events surrounding the black out and 3-4 hours afterwards. Furthermore, it was reported that when swiping the magnet the patient does not feel the magnet stimulation. No additional relevant information has been obtained to date.

Event Description
An implant card was received indicating that the patient underwent prophylactic generator replacement. It was reported that the explanted generator was discarded by the explanting facility.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5339671


Title: Re: New Seizure Type
Post by: dennis100 on December 20, 2017, 08:30:56 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by the patient that she had been having issues that resulted in hospital visits. The issues were suggested to be related to the vns device. Information was later received from the patient¿s mother who stated the patient was presenting with new seizures. The vns magnet was used to abort one of the seizures and this was effective. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7429709


Title: Re: New Seizure Type
Post by: dennis100 on December 21, 2017, 03:06:52 AM
Model Number 102
Event Date 11/01/2011
Event Type Injury
Event Description
The patient had their generator replaced on (b)(6) 2012. The explanted generator is being returned for analysis. Additional information was received. It is unknown when the patient's seizure event first started. She has poor memory. Their dcdc was a 5 so referred for a battery change. Unknown if their seizure frequency was above their prevns level as not documented. The patient's last medication change was on (b)(6) 2011 an increase in keppra. It is unclear the relationship of their psychosis to their vns.

Event Description
The patient had a prophylactic generator replacement. The generator is at the manufacture pending completion of product analysis.

Event Description
Clinic notes were received for review from a patient office visit dated (b)(6) 2012. The vns patient does not remember all of her seizures and believes that they have not increased in frequency. Her husband believes her seizures have been increasing in frequency over the last few months. He also reports she is now having seizures that start as staring spells and did not have these prevns. The patient's vns was interrogated and set at 1. 75/500/30/30/5 magnet 2/500/60. Normal mode diagnostic testing showed at dcdc 5 and system diagnostic results of dcdc 2 eri no. However, according to her husband, the patient has been having an increase in seizure activity over the last few months. He also notes she is having seizures that start as staring episodes, and then she will fall. He states, she has not had these types of event since prior to her vns implantation. Therefore, it appears that the vns is likely nearing eos and today she will be referred for battery change. No surgery is scheduled at this time. On (b)(6) 2011, the patient was admitted to hospital for 2 weeks due to psychosis. Device function was confirmed. The patient has a history of major depression/catatonia. Good faith attempts have been made for further details about the reported event and thus far no further information has been attained.

Event Description
Analysis was completed on the patient's generator. In the 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. In addition, 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. The patient's implant card reported their generator was replaced for prophylactic reasons.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2434874


Title: Re: New Seizure Type
Post by: dennis100 on December 31, 2017, 02:40:31 AM
Model Number 103
Event Date 10/19/2013
Event Type Injury
Manufacturer Narrative

Event Description
Initially, it was reported that the patient developed a new seizure since generator replacement that was head bobbing. Clinic notes dated (b)(6) 2014 were received indicating that the patient's father would like the vns removed because he feels that the patient's head bobbing was related to vns. It was noted that the vns remains off and no head bobbing episodes have been seen. The patient was referred for surgery. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4226801


Title: Re: New Seizure Type
Post by: dennis100 on January 03, 2018, 02:07:54 AM
Model Number 102
Event Date 01/12/2015
Event Type  Malfunction   
Event Description
It was reported that the recently implanted vns patient experienced successive seizures nonstop for 30 minutes. The patient was taken to the or and the seizures stopped at that time. The patient¿s device output current was increased from 0. 25ma to 0. 5ma earlier that day. No intervention was taken. It was noted that the patient had not previously experienced seizures of this type. No medication changes preceded the onset of the event. Prior to vns, the patient averaged three seizures per day. Diagnostic results showed normal device function at the time of implant. The physician indicated that all of the patient¿s seizure types had increased. The patient was reported to be stable now.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4491065


Title: Re: New Seizure Type
Post by: dennis100 on January 06, 2018, 04:36:42 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 11/13/2017
Event Type Injury
Manufacturer Narrative

Event Description
The patient reported that for the past two to three weeks she believes to have experienced a new type of seizure. The patient reported approximately twice a week to have woken up in a sweat feeling as if she had fallen. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7140101


Title: Re: New Seizure Type
Post by: dennis100 on January 08, 2018, 02:37:18 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 06/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by a patient that his seizure type changed approximately 1. 5 years ago. He clarified that his seizures were not more frequent, but they were just a different type of seizure. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6300402


Title: Re: New Seizure Type
Post by: dennis100 on January 09, 2018, 03:07:05 AM
Model Number 102
Event Date 04/01/2009
Event Type Injury
Event Description
Pt had cluster of 7 seizures over 2 days, resulting in emergency room visit and hospitalization on epilepsy monitoring unit. A few days prior to this, patient had a suspected seizure that was different in appearance than prior events. Medication changes were made. During the hospitalization, patient was placed on eeg telemetry where two seizures were recorded with a period of asystole lasting 18 seconds during the seizure. The patient did not have a prior history of bradycardia or cardiac difficulties. Since patient had an implanted vagus nerve stimulator, this was interrogated and tested to ensure that the device was working properly. Testing the device was not associated with change in heart rate. Epilepsy team believes that the seizure was associated with asystole and not the vagus nerve stimulator, but since asystole had been reported in a few instances of new implants with vns, the vns device was watched carefully in this patient. A cardiac pacemaker was implanted and the vns was tested during this procedure. The vns was not found to interfere or affect the cardiac pacemaker. The vns is gradually being reprogrammed to the patient's usual settings as a treatment for her seizures. Patient's medications were adjusted during the hospitalization, and she was discharged twelve days later in 2009. Pt seen in clinic today for follow-up of vns and no further problems have been noted. Diagnosis or reason for use: intractable epilepsy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1365329


Title: Re: New Seizure Type
Post by: dennis100 on January 09, 2018, 03:07:45 AM
Model Number 104
Event Date 04/22/2009
Event Type Injury
Event Description
It was reported by the physician that the patient had a drop attack seizure a few days after the generator replacement due to eos. The patient's settings were programmed to the last known settings upon completion of surgery. The physician indicated that he feels that the patient's seizure was attributed to the vns therapy and being turned on abruptly to the last known settings since she had never experienced a drop attack seizure before. The device has been disabled at this time. Diagnostics performed indicate that it is within normal limits. There is no suspected device failure at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1393199


Title: Re: New Seizure Type
Post by: dennis100 on January 10, 2018, 02:05:43 AM
Model Number 103
Event Date 01/01/2009
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history.

Event Description
The pt's treating physician reported that when he tried to interrogate the pt's device, the settings had been reset. During the time, the device was off the pt went to the er following a generalized tonic colonic seizure, which is a new seizure type for the pt. The treating physician did not specify a cause for the new seizure type. Review of programming history confirmed that generator being disabled was due to a burst watchdog timeout. However, the reporter indicated a pt name that did not match the initials in the downloaded programming history. Attempts to clarify the pt- initials discrepancy with the physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1338733


Title: Re: New Seizure Type
Post by: dennis100 on January 11, 2018, 02:44:55 AM
Model Number 102R
Event Date 05/01/2009
Event Type Injury
Event Description
It was reported to manufacturer that the vns patient was recently experiencing a new seizure type and an increase in the pre-existing seizures, below the pre-vns baseline. The reporter indicated that the vns device is believed to be nearing end of service. A battery life calculation was performed with the available programming history and confirmed that the generator is likely at end of service. Good faith attempts to obtain additional information from the treating physician regarding the events have been made, but have been unsuccessful to date. The patient subsequently had surgery where the generator was replaced without incident. The explanted generator has been returned to manufacturer and the device analysis is underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1403970


Title: Re: New Seizure Type
Post by: dennis100 on January 11, 2018, 02:45:51 AM
Model Number 102
Device Problem Device inoperable
Event Date 04/10/2009
Event Type Malfunction
Event Description
It was reported that a pt's seizures had worsened recently and that the physician indicated, the device was not working and would need to be replaced. The pt states that now seizures are occuring two to three times a day and now the seizure type has changed in that the pt will now black out and feel like time is passing by rapidly. A battery life calculation was performed using the limited data available in the in-house programming database and it was found that the pt's device is currently at end of service. Good faith attempts to obtain additional info from the pt's physicians have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1468064


Title: Re: New Seizure Type
Post by: dennis100 on January 11, 2018, 02:46:45 AM
Model Number 100 C
Event Date 09/26/2000
Event Type Injury
Manufacturer Narrative
Article citation: koutroumanidis, michael, michael j. Hennessy, colin d. Binnie, and charles e. Polkey. "aggravation of partial epilepsy and emergence of new seizure type during treatment with vns. " neurology 55 (2000): 892-93.

Event Description
It was reported in a scientific article that a vns patient, who had initially responded to vns therapy, began to experience an "abrupt worsening of her epilepsy" after increasing her therapy output current by 0. 25ma (2. 25ma to 2. 50ma). The author indicated that this worsened seizure activity consisted of an increase in seizure frequency, above pre-vns baseline levels, as well as the development of a new seizure type. The article states that the patient had "no history of recent aed changes or dose omission, protracted sleep deprivation, stressful events, trauma, or intervening infection could be elicited and both the generator and the lead were functioning normally". The author states that once the patient's ncp device was programmed off, "2 days later the new seizure type ceased and the patient's habitual seizures settled down to pre-implantation baseline. " in light of these events, the pt's device was reportedly programmed back on a month later due to the initial efficacy she had received from vns therapy. The pt's output current was gradually increased up to 1. 75ma and after six months of follow up, the patient reportedly regained the efficacy that she had initially obtained with no relapse of the new seizure type.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1400101


Title: Re: New Seizure Type
Post by: dennis100 on January 11, 2018, 02:48:15 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


Title: Re: New Seizure Type
Post by: dennis100 on January 12, 2018, 01:55:17 AM
Model Number 101
Event Date 01/01/2004
Event Type Injury
Event Description
Reporter indicated that the pt began having grand mal seizures approximately 5 years ago, which he did not have before vns was implanted. It was also noted that the pt has had an increase in his seizure activity. Info suggests that a number of medication changes have occurred to try to help control the pt's seizures more effectively. Info received suggests that the pt was receiving vns therapy for approximately 3 years prior to the onset of the grand mal seizures, and no timeline is known for the onset of the increased seizure activity. All attempts for further info have been unsuccessful, thus the relationship between the reported events and vns therapy cannot be determined.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1449915


Title: Re: New Seizure Type
Post by: dennis100 on January 13, 2018, 01:46:47 AM
Event Date 01/01/2004
Event Type Injury
Manufacturer Narrative
Article citation: vagus nerve stimulation therapy: 2 year prospective open label study of 40 subjects with refractory epilepsy and low iq who are living in long-term care facilities. Epilepsy and behavior 2005; 6:417-423. Huf, roger, et al.

Event Description
Reporter indicated via the published journal article "vagus nerve stimulation therapy: 2 year prospective open label study of 40 subjects with refractory epilepsy and low iq who are living in long-term care facilities. Epilepsy and behavior 2005; 6:417-423. Huf, roger, et al. " that a newly implanted vns pt developed a new seizure type (cluster seizures). All attempts for additional info from the reporter have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1488715


Title: Re: New Seizure Type
Post by: dennis100 on January 13, 2018, 01:47:28 AM
Model Number 102
Event Date 01/01/2009
Event Type Malfunction
Event Description
Reporter indicated that the pt was experiencing an increase in seizures and was now also having grand mal seizures, which the pt had not previously had. All attempts for further info regarding the issue have been unsuccessful to date, thus the relationship between the issues and vns therapy cannot be determined.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1502871


Title: Re: New Seizure Type
Post by: dennis100 on January 14, 2018, 01:43:59 AM
Model Number 302-20
Event Date 04/21/2009
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected, but did not cause a death.

Event Description
Clinic notes were received that reported a pt had high lead impedance, having a change in their seizure type and increased seizures around the time of the event. The pt underwent full revision surgery, and the explanted product is at the mfr pending completion of product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1514166


Title: Re: New Seizure Type
Post by: dennis100 on January 14, 2018, 01:44:40 AM
Model Number 102R
Event Date 06/15/2009
Event Type Injury
Event Description
Clinicals were received and reviewed at mfr. Notes reported that the pt had several admissions to the hosp for breakthrough seizures and grandmal seizures, diastat did not abort the pt's seizures. Medications were titrated. The pt had also been having a change in seizure type based on the pt's presentation during her seizures. It is unk if the pt's seizures are above their pre vns seizure rate. The pt will be scheduled to have a prophylactic generator replacement. Good faith attempts are being made for add'l details.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1461374


Title: Re: New Seizure Type
Post by: dennis100 on January 14, 2018, 01:45:20 AM
Model Number 103
Event Date 06/27/2009
Event Type Injury
Event Description
The patient's treating physician reported that their patient was having increased seizures and that they were a new seizure type since raising their vns settings. When the patient's vns settings were raised from 0. 5ma output current to 0. 75ma output current the event started. The patent's therapy was lowered back down to 0. 25 ma output current and they have now been seizure free for three weeks, the patient since the change in programmed settings has been doing very well with their vns therapy and the treating physician attributes the event to their settings being raised to fast and over stimulating the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1464534


Title: Re: New Seizure Type
Post by: dennis100 on January 15, 2018, 02:25:35 AM
Model Number 102
Event Date 01/01/2008
Event Type Injury
Event Description
Reporter indicated that the patient was experiencing a new type of seizures, and that she had been having a flurry of seizures. The patient was put on felbarnate to try to control the reported events. All attempts for further information have been unsuccessful to date, thus the relationship between vns therapy, and the reported events cannot be determined.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1509540


Title: Re: New Seizure Type
Post by: dennis100 on January 20, 2018, 02:50:09 AM
Model Number 302-20
Event Date 06/12/2014
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.

Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results showed high impedance (dc dc ¿ 7). The patient¿s parent stated that she no longer heard the patient¿s voice alteration that normally occurred with stimulation. The patient went to the hospital on (b)(6) 2014 after having three generalized seizures the previous week. It was noted that a football hit the patient in the chest/clavicle the previous week. The physician stated that the reported event was related to vns stimulation. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown. Further follow-up revealed that the patient¿s device was disabled on (b)(6) 2014. The patient¿s seizures had changed in type and were longer. Prior to the event, the patient only had simple seizures. The patient underwent lead replacement surgery on (b)(6) 2014. The explanted lead has not been returned to date. The patient was doing well following lead replacement surgery.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death.

Event Description
Additional information was received stating that the vns patient underwent lead replacement surgery due to lead discontinuity. The explanted lead was returned to the manufacturer for analysis. Based on the findings, there is evidence to suggest discontinuities in the returned portions of the lead may have contributed to the reported high impedance. During the visual analysis, quadfilar coil 1 appeared to be broken approximately 24mm from the electrode bifurcation. Scanning electron microscopy was performed on the connector end of the quadfilar coil 1 coil break and identified the area on two of the broken strands as being mechanically damaged which prevented identification of the coil fracture type and no pitting. The area on a third broken coil strand was identified as having evidence of a stress induced fracture with mechanical damage and no pitting. Determination could not conclusively be made on the fracture mechanism. The area on the remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. Scanning electron microscopy was performed on the electrode (mating end) of quadfilar coil 2 coil break (found at 24mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Pitting was observed on the 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. The abraded openings and slice mark found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. With the exception of the observed discontinuity 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 setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed and no other discontinuities were identified. Note that since the (+) white electrode 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=3918410


Title: Re: New Seizure Type
Post by: dennis100 on January 22, 2018, 02:16:42 AM
Model Number 101
Event Date 04/27/2010
Event Type Injury
Event Description
Clinic notes for this pt were received which documented a new seizure type of an unspecified cause. There was note that there was suspicion of psychogenic non-epileptic seizures (pnes), however, the physician requested an ambulatory eeg be performed as soon as possible in order to characterize the seizure type. It was noted that the pt was scheduled for generator replacement surgery, which took place on may 27th to prophylactically replace the device. The explanted generator has been returned to mfr where analysis is underway. Good faith attempts to obtain additional info regarding the new seizure type and the believed relationship to vns therapy have been made, but no additional info has been received to date. Diagnostic testing done one month prior to the report of the new seizure type revealed normal device function.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1739603


Title: Re: New Seizure Type
Post by: dennis100 on January 22, 2018, 02:17:27 AM
Model Number 102
Event Date 07/01/2009
Event Type Injury
Event Description
It was reported that a patient experienced a series of seizures that were different from her normal seizure type. The physician wondered if maybe the device was not functioning properly regardless of acceptable diagnostics. The patient could not tell whether or not her device was on. The physician did state that it is difficult to tell if these new seizures are new seizure types of if they are pseudoseizures. The patient has been referred for generator revision however, the surgery is on hold.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1744398


Title: Re: New Seizure Type
Post by: dennis100 on January 23, 2018, 03:33:04 AM
Model Number 302-20
Event Date 04/28/2010
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Results: x-rays reviewed by manufacturer, gross lead discontinuity noted. Conclusions: device failure occurred, but did not cause or contribute to a death.

Event Description
Our country manager for (b)(6) reported that there was a patient with high lead impedance on their system diagnostic testing. Over the last month it was reported that the patient experienced an increase in seizures at their pre vns baseline rate, new seizure type and tonic seizures with falls to the ground. Additionally it was reported that the patient had a violent fall in (b)(6) with trauma on the face. The patient had falls prior to vns implantation with their seizures and now, they have returned. The patient's seizures are being attributed to their high lead impedance/lead break. The patient's mother cannot remember tonic seizures with so violent falls before implantation. Reported it seems that these may be a new type of seizures. X-rays were reviewed at manufacturer and showed a gross lead discontinuity in the anchor tether area of the lead that is in the neck area. Lead replacement is scheduled for (b)(6) 2010. Good faith attempts will be made for the explanted product to be returned for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1724222


Title: Re: New Seizure Type
Post by: dennis100 on January 24, 2018, 03:14:56 AM
Model Number 102
Event Date 05/01/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by the surgeon's office that the patient had generator replacement surgery on (b)(6) 2012. However, attempts for product return have been unsuccessful to date.
 
Event Description
Clinic notes dated (b)(6) 2012 were received by the manufacturer and reported that the patient had been experiencing lue/lee twitching episodes for the prior six months that last for about three to four minutes with no impairment of consciousness. In the notes dated (b)(6) 2012, it was indicated that the patient usually had mix types of seizure including grand mal, petit mal, partial seizure. After vns placement, he has not had any grand mal seizure in the past five years. Currently, he describes the seizure as arm, eye twitch (early sign). These events were now happening about once a week. Follow-up with the treating physician was performed. He reported that the patient's new seizure type is not believed to be related to any vns problem, and his vns seems to be fully functional. However, the manufacturer battery life calculation determined that as of november he had less than half a year left on his battery. That fact, combined with the fact that since then i have increased his settings to 2. 0ma on (b)(6) 2012, which will most likely lead to an even shorter battery life, led the physician to believe that it is best to replace the generator prophylactically. The physician also reported that he has no way to know if the increased seizures are related to vns. The patient feels the vns stimulation, and the interrogation says that it is not near end of service. Therefore, the physician stated that he has no reason to suspect that the vns is not functioning properly, although perhaps the battery is "just low enough to cause an increase in seizures. " although surgery is likely, it has not occurred to date.
 
Event Description
Attempts for product return were unsuccessful as the explanting facility indicated that they could not locate the explanted generator, so it was assumed by the facility that the device was discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2874197


Title: Re: New Seizure Type
Post by: dennis100 on January 28, 2018, 02:05:35 AM
Model Number 103
Event Date 09/07/2010
Event Type Injury
Event Description
It was reported that a vns pt experienced a new type of seizure as the pt began to experience brief tonic-clonic seizures that lasted 10-20 seconds and were increasing in frequency. The pt had recently undergone vns placement and was not programmed on after surgery. The pt was programmed on at a follow-up appointment with the treating neurologist. The neurologist believed the increase in change was possibly due to the anesthesia or trauma/stress but could not confirm. Additional info was received through a fax with clinic notes which stated: "there has been an increase of seizure frequency, especially brief episodes. Given his increased seizure frequency, i am recommending checking drug levels today. Vns was also started at. 25 ma ever 180 min. He appeared to tolerate this procedure well. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1872832


Title: Re: New Seizure Type
Post by: dennis100 on February 09, 2018, 11:59:11 AM
Device Problem No Known Device Problem
Event Type Injury
Manufacturer Narrative

Event Description
Report received that vns caused a patient's seizure type to change from grand mal to partial complex and atonic. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7192007


Title: Re: New Seizure Type
Post by: dennis100 on February 09, 2018, 11:59:54 AM
Model Number 103
Device Problem No Known Device Problem
Event Type Malfunction
Manufacturer Narrative

Event Description
A physician's office reported that a patient was experiencing an increase in seizures and presenting with different seizure types. The patient was referred to another physician in order to be evaluated for another treatment. No additional information has been received to date. No known relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7187914


Title: Re: New Seizure Type
Post by: dennis100 on February 21, 2018, 02:16:21 AM
Model Number 302-30
Device Problem Fracture
Event Date 07/24/2017
Event Type  Malfunction   
Event Description
A patient had been referred for generator replacement surgery due to end-of-service. During the replacement surgery, high impedance was identified on systems diagnostics, which did not resolve after the generator was replaced. A lead revision was planned but no known surgery has occurred to-date to replace the lead. The patient was reported to have been experiencing more and different types of seizures prior to the replacement. The explanted device has not been received by the manufacturer to-date.
 
Event Description
The explanted generator was received by the manufacturer and analysis was completed. Measurement of the battery voltage confirmed that the battery was depleted and was the result of normal battery depletion. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Lead revision surgery occurred. The explanted device has not been received by the manufacturer to-date.
 
Event Description
The explanted device was discarded by the hospital.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6801987


Title: Re: New Seizure Type
Post by: dennis100 on February 28, 2018, 02:19:26 AM
Event Date 11/27/2013
Event Type Injury
Manufacturer Narrative

Event Description
A maude event report ((b)(4)) was received indicating that the patient was found unresponsive with a heart rate of 16 bpm. It was reported that the patient was hospitalized and intubated and that the patient was released several days later. It was also noted that the patient has experienced an increase in seizures for the past few months and that the seizures are different than prior seizures. It was reported that the patient no longer experiences her usual aura and no post-ictal state. It was reported that vns induced asystole/bradycardia is suspected. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3651797


Title: Re: New Seizure Type
Post by: dennis100 on March 05, 2018, 02:34:40 AM
Model Number 102
Event Date 03/22/2012
Event Type Injury
Event Description
Clinical received into (b)(6) on (b)(6) 2012 from cm (b)(6) regarding patient (b)(6)'s upcoming replacement. It was reported through clinic notes received on (b)(4) 2012 that the patient felt his seizures had changed. It was reported that he had three seizures which were 'somewhat different'. He reported that with these seizures, he began shaking and then stiffened, the patient also reported eye jerks. It was indicated by the physician that the patient needed his vns battery checked. There were no diagnostic results or patient settings provided in the clinic notes. The patient has since been referred for revision; however, this has not occurred to date. Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative

Event Description
The explanted generator will likely not be returned as per the or coordinator at the hospital, they currently do not have the device to return and they assume that it was discarded in surgery. Attempts for additional information have remained unsuccessful. A rough estimate of battery life was performed with programming history that was only available from the date of implant until (b)(6) 2010. This estimation indicated that the generator may have been at or nearing end of service at the time of replacement.

Event Description
Additional information was received on (b)(4) 2012, indicating that the patient underwent revision on (b)(6) 2012. Attempts for product return and additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2579096


Title: Re: New Seizure Type
Post by: dennis100 on March 08, 2018, 09:55:19 AM
Model Number 102R
Event Date 11/08/2010
Event Type Injury
Manufacturer Narrative
Review of programming/device diagnostic history performed.

Event Description
On (b)(6), 2012, a fax was received from the physician with information regarding the patient's change in seizure pattern from (b)(6), 2010. The physician stated that there was no relationship of the event to vns. The change in seizure pattern was not significant. The interventions taken included checking the patient's levels, educating the patient, and checking the vns. No causal or contributory programming changes, medication changes or other external factors preceded the onset of the change in seizure pattern.

Event Description
Clinic notes dated (b)(6) 2010 were received on may 6, 2012 regarding this vns patient. The clinic notes allege that the patient's recent seizures have been different than those in the past. The patient reports doing things or having conversations after his seizures and then having no recollection of those events. Sometimes, he will wake up or become aware of his surroundings without knowing how he got there. The patient reports having pre-seizure activity one to two times per week. Occasionally, swiping his magnet will stop the seizure. The patient's last generalized tonic-clonic seizure was about one month ago ((b)(6) 2010). The patient's seizures are characterized as generalize tonic, clonic movements, deviation of eyes and head to one side and focal movements followed by generalized clonic movements. The seizures are preceded by an aura and followed by confusion and lethargy. The patient is having more difficulty remembering how he got to places, losing track of time, and his caretaker reports he just seems "out of it at times. " the patient has been incontinent at times but no tongue biting has been reported. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2595567


Title: Re: New Seizure Type
Post by: dennis100 on March 09, 2018, 04:18:34 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 01/01/2018
Event Type Injury
Manufacturer Narrative

Event Description
Patient's vns output currents were increased from about a month ago. Since that time, caregiver has noticed new events that when patient gets excited or laughing, he will suddenly fall to the ground and be limp for a short time. On initial discussion, this was thought to be a new seizure type or cataplexy but the nurse practitioner wanted to know if this could be a type of vasovagal event occurring when the device is stimulating. The nurse practitioner increased the device output current again with the thought the events could be seizures.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7301451


Title: Re: New Seizure Type
Post by: dennis100 on March 11, 2018, 01:14:23 AM
Model Number 102R
Event Date 07/21/2009
Event Type Injury
Event Description
It was reported that the vns patient experienced a tonic-clonic seizure following generator replacement surgery and was hospitalized overnight. The patient reportedly never experienced tonic-clonic seizures before the event. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4442826


Title: Re: New Seizure Type
Post by: dennis100 on March 12, 2018, 01:51:38 AM
Model Number 103
Event Date 03/05/2012
Event Type Injury
Manufacturer Narrative

Event Description
Product analysis on the explanted generator was approved on (b)(6) 2012. Review of the data indicated that the pulsedisabled was set to a value that does represent a vbat

Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2012 were received on (b)(6) 2012. These stated that the patient's vns generator recently reached end of life. The patient was having increased seizures. Recent lead tests showed that it was ok. The battery life was evaluated in (b)(6) 2011 with the reading indicating 18 months of remaining battery life. It was checked again in (b)(6), and the battery life still appeared sufficient. One month later (b)(6), the patients seizures activity increased, and the red light started flashing on the battery indicator. The patient's reported that the patient typically has between 2 and 40 seizures per day of brief duration. The seizures were described as drop seizures manifested by fluttering of eyelids, upper extremity laxity and gibberish speech. The seizures tend to occur in clusters. The patient had three seizures during the exam. The patient's eyes fluttered up and rhythmically beat, and there was behavioral arrest. The seizures lasted 30-45 seconds. During one seizure, the patient became quite limp during falling forwards. ; however, she immediately returned to baseline. Shortly after (b)(6) of the previous year, the patient began a ketogenic diet and the seizure frequency decreased. Additional clinic notes were received on (b)(6) 2012. Clinic notes dated (b)(6) 2012 described the patient's seizure semiology: the patient has brief drop seizures where her body will collapse down and the head flexes forward. Prior to the ketogenic diet, the patient had 40 to 50 seizures per day; however, at this time, she was having 6 to 15 per day. The patient also had tonic stiffening all over. These occurred 40 times per day pre-diet and 30 per day at this time. The patient also had spacing out seizures with the eye deviating upwards and outwards disconjugately. These may have been from one to 200 times daily, lasting five to 30 seconds. This frequency has stayed the same since the diet; however, they have become a new seizure type: the patient will speak and the speech will become unintelligible. The eyes will flicker, and the head drops. The patient tried to refocus but has difficulty with speech or her head will drop again. These last 90 to 120 seconds. Sometimes she will howl with these seizures. The patient had 15 of these in the last month. The patient's device was interrogated at this appointment. Clinic notes dated (b)(6) 2012 indicated that the reason for appointment was a history of rsv/ congestion. (it was also indicated that the patient had a cough for the past two days. ) clinic notes dated (b)(6) 2012 indicated that the patient's battery life was red. In (b)(6) 2011, the device was reported to have one-third of its life remaining. The patient's seizures had increased back to 30 per day. On (b)(6) 2012, additional programming and diagnostic history was provided from (b)(6) 2012 and (b)(6) 2012. Attempts for additional information have been unsuccessful. Surgery is likely, but has not occurred.

Event Description
On (b)(6) 2012, it was reported that this vns patient underwent surgery. During surgery, high impedance was seen. The high impedance report is captured in mfr report #1644487-2012-02047. The explanted generator was received on (b)(4) 2012 and is currently undergoing product analysis. On (b)(6) 2012, follow-up with the patient's physician was performed. The patient's device was last interrogated in (b)(6) 2011 and low battery was seen (one-quarter to one-third of battery life remaining). When the device was patient was seen for follow-up, it was noted that the battery was dead. The increase in seizures was attributed to the battery being dead. The physician believed the battery depleted very quickly from (b)(6) 2011 to (b)(6) 2012. The patient's device was turned on after surgery. The patient was seen post-operatively on (b)(6) 2012, with ok impedance at 3059 ohms. The patient was doing okay with modest seizure control, and the patient's settings were provided. It was stated that the settings would be gradually increased to their previous values. (the exact values were not provided.).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2665729


Title: Re: New Seizure Type
Post by: dennis100 on March 29, 2018, 01:25:25 AM
Event Date 11/27/2013
Event Type  Injury   
Event Description
Patient found unresponsive with heart rate of 16 - was hospitalized and intubated; released after several days; patient noted to have increased seizures for the past few months - seizures are different from prior seizures in that she sometimes just drops to the floor without her usual aura and no post-ictal state. Suspect vns-induced asystole/bradycardia.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3502109


Title: Re: New Seizure Type
Post by: dennis100 on March 31, 2018, 01:19:54 AM
Model Number 103
Device Problem No Information
Event Date 06/01/2015
Event Type Malfunction
Event Description
Review of the patient's programming history available in the manufacturer's programming history database revealed diagnostics data for the date of implant, (b)(6) 2013.

Manufacturer Narrative

Event Description
It was reported that the vns patient had been experiencing an increase in seizures for the past few weeks and may have developed a new seizure type. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4956763


Title: Re: New Seizure Type
Post by: dennis100 on April 01, 2018, 02:06:25 AM
Model Number 103
Device Problem Migration of device or device component
Event Date 05/08/2015
Event Type  Injury   
Event Description
It was reported that a patient has neuropathy at the lead site. She reported constant pain in the neck, numbness under the chin, and a lead pulling sensation. She also reported that the device has migrated and is experiencing pain from the migration at the chest site. The patient has been referred for surgery. No known surgical interventions have occurred to date.
 
Event Description
Patient was implanted with vns on (b)(6) 2015. Vns was programmed on on (b)(6) 2015. Initially, the magnet was helping with her seizures. Additional information was received that the patient's vns was removed on (b)(6) 2015. It was removed due to all of patient's symptoms. Patient also had an increase in seizures above her pre-vns baseline and started having convulsions which she did not have prior to vns. Patient never reached therapeutic levels and the device was disabled on (b)(6) 2015. Clinic notes dated (b)(6) 2015 were received indicating that since the patients last visit, patient's vns has shifted down from the original placement spot. Patient has been experiencing painful sensations in the left face and under both sides of her jaw. This spreads down the front of the left side of her neck. Patient describes the pain as pins and needles. This occurs randomly and not just when the vns is stimulation and worsens considerably with magnet mode (higher output current) stimulation. Patient has difficulty with daily activity due to the generator moving around. When the magnet was swiped, significant dystonic pulling of the left face and neck was noted associated with extreme discomfort on the part of the patient. The vns was turned off as a result. Physician's assessment was that the patient's painful facial and neck sensation and dystonic motor movements of the face and neck may represent a spread of electrical current and the entire system should be removed and replaced. Patient visited the hospital on (b)(6) 2015 because of a generalized seizure and an increase in the pain patient also had a convulsion. Noted dated (b)(6) 2015 indicates that the patient's headaches are worse since the increase in vns settings. Patient feels soreness at the vns generator site. It is implanted more medially in the chest wall near the sternum, rather than the axillary area. She feels that her vns has turned and is now vertical. This is pulling on the lead in her neck. Since the surgery, the vns has rotated and dropped inferiorly, placing a weight and stretching burden on the lead attached to the vagal nerve. Patient's normal and magnet mode output current were decreased from 0. 5 ma and 0. 75 ma to 0. 25 ma and 0,5 ma respectively. The explanted products will not be returned to manufacturer unless the patient signs a release form.
 
Manufacturer Narrative
Suspect device udi: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5088394


Title: Re: New Seizure Type
Post by: dennis100 on April 07, 2018, 01:21:28 AM
Model Number 104
Device Problem No Known Device Problem
Event Date 02/22/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinical notes were received stating that the patient was experiencing a new type of seizure and it was noted that these were due to the vns battery being nearly depleted. The patient was referred for surgery. No relevant surgical intervention is known to have occurred 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=7365928


Title: Re: New Seizure Type
Post by: dennis100 on April 12, 2018, 12:27:22 AM
Model Number 103
Event Date 01/01/2014
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2014 indicate that the patient's initial seizures were described as the patient would drop down without any warning and would have occasional bladder incontinence with it. It was noted that the patient's usual seizures now are described as the patient sitting and his head turns back and he stops breathing and loses consciousness briefly. It was noted that the patient has a history of grand mal seizures since age 14 years. It was noted that the patient experiences 1-2 seizures per month. The patient was referred for surgery. The relationship of the change in seizures to vns is unknown. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical intervention has been performed to date.
 
Event Description
An implant card was received indicating that the vns patient underwent generator replacement surgery on (b)(6) 2014. The explanted generator has been returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative

Event Description
Product analysis was completed and approved for the m103 generator on 12/02/2014. 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery voltage showed an ifi = yes condition. 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=4175775


Title: Re: New Seizure Type
Post by: dennis100 on April 15, 2018, 12:43:27 AM
Model Number 304-30
Event Date 12/10/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2013 it was reported that per the physician's notes, the patient's electrodes and generator were removed but the surgeon felt that there was not enough space to reimplant new electrodes due to scar tissue and therefore did not reimplant the patient. It was also reported that the explanted generator would be returned to the manufacturer for product analysis. The explanted generator was returned to the manufacturer for product analysis on (b)(4) 2013. Product analysis is still underway and has not yet been completed.
 
Event Description
Good faith attempts for the return of the explanted products were unsuccessful.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records for the lead confirmed device met all specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2013 it was reported that the patient's lead is broken and was referred for revision surgery. Because the patient has shunted hydrocephalus and no recent imaging, it was stated that prior to surgery a brain mri would be performed to make sure the patient's ventricles aren't enlarged. Clinic notes were received dated (b)(6) 2013 revealed that the week prior, the patient reportedly had 30 "small" seizures on the school bus. The patient normally has about 2 generalized tonic-clonic seizures per month and 1-2 smaller tonic-clonic seizures that affect upper extremities only. The patient's grandmother noticed that the patient has recently started looking upward and the left with left eye deviation and left arm flexion during the smaller seizures. The physician noted that there is no significant change on seizure amount as per family members. High impedance was noted that day during interrogation and "a broken wire was detected". The patient's settings were noted to be output=1. 75ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=0. 8min/magnet output=2ma/magnet on time=60sec/magnet pulse width=500usec. Clinic notes dated (b)(6) 2012 indicate that for the last two weeks, the patient is presenting with sporadic jerking movements in the right shoulder during the night and the patient's guardian recounts a different type of seizure involving a shaking of the upper extremity that lasts one to two seconds and results in postictal dizziness. The patient underwent a full revision surgery on (b)(6) 2013. The hospital reported that the lead would not be returned to the manufacturer for product analysis. Attempts for the return of the explanted generator are underway but it has not been returned to the manufacturer to date. Good faith attempts for further information from the physician have been unsuccessful. The manufacturing records for the lead were reviewed and device met all specifications prior to distribution.
 
Manufacturer Narrative
Additional information was received which changes the event date from what was originally reported.
 
Event Description
Product analysis on the explanted generator was completed on (b)(6) 2013. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The generator¿s internal memory showed that the impedance value increased from 1346 ohms to 10,000 ohms on (b)(6) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2985124


Title: Re: New Seizure Type
Post by: dennis100 on April 17, 2018, 01:12:43 AM
Model Number 102
Event Date 07/01/2012
Event Type  Injury   
Manufacturer Narrative
Describe event or problem, corrected data: supplemental report #1 did not indicate that the device will not be explanted due to the hospital's privacy policy. The information has been included in this report.
 
Event Description
On (b)(6) 2013 clinic notes dated (b)(6) 2013, were received which indicated that the vns patient was admitted to the emergency room on (b)(6) 2013, due to a new seizures type and a new right arm weakness. On the night prior, the patient felt a sudden jerking of her right leg which came up off the bed, followed by her right arm which was shaking as well. The patient stated that it reminded her of a grand mal seizure which she had at age (b)(6), which was unusual for her. The patient's arm became numb, and this was a different seizure, so they wanted to admit the patient after having a head ct which showed abnormalities, nothing acute. The plan was to admit her, and do a video eeg there, thinking that these may be different seizures. It was decided to transfer her, in order to rule out the possibility of stroke, which was doubtful (as this was thought to be a todd's paralysis based on her (b)(6) hmri) but just to make sure there was nothing else going on. By the morning the patient regained her strength in the right hand, suggesting that this was postictal todd's paralysis as suspected. The clinic notes mention that due to the fact that she has been in the er with seizures lately, the last week, and a few other times in the er for other seizures, it may be that she is having a combination of epilespy but also none-epileptic seizures. Clinic notes dated (b)(6) 2013, indicate that the vns battery is at end of service and that before (b)(6) 2012 the patient seizures were picking up, but since (b)(6) 2012, she has had a lot more seizures that are bigger; averaging 2-6 convulsions per month. It was stated that the vns is giving her a little bit of shortness of breath now and then, although she says the symptoms are tolerable. The patient was referred for surgery. Although surgery is likely, it has not occurred to date. A blc was performed which showed 6. 4 years remaining until eri=yes. Good faith attempts for further information from the physician were unsuccessful.
 
Event Description
An implant card was received which indicates that the vns device was explanted on (b)(6) 2013.
 
Manufacturer Narrative

Event Description
The patient¿s explanted generator will not be returned for analysis due to the hospital¿s privacy policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3065662


Title: Re: New Seizure Type
Post by: dennis100 on April 18, 2018, 01:08:53 AM
Model Number 300-20
Event Date 02/22/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted lead and generator were returned to the manufacturer on (b)(4) 2013 and are pending product analysis.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
Reporter indicated via the manufacturer¿s implant card that the patient had vns generator and lead replacement surgery on (b)(6) 2013 due to ¿increased seizures¿, and that a new model 104 vns generator was ¿wasted, inserted, and removed¿ but not implanted at the surgery. Attempts for additional information and return of the explanted devices are in progress.
 
Event Description
Reporter indicated high lead impedance was observed for a patient at an office visit on (b)(6) 2013. Approximately two to three weeks prior to the office visit, the patient began experiencing dizziness, not feeling vns stimulation, and the patient's seizures were described as "different". The vns was disabled and x-rays were performed but will not be sent to the manufacturer. Vns diagnostics were last within normal limits in (b)(6) 2013. The patient had no known trauma and does not manipulate the vns. The patient is active is sports. The reporter feels the vns lead may be broken and causing the change in seizures, dizziness, and stimulation not perceived. No programming or medication changes preceded these issues. Surgery to replace the vns lead and generator is likely, but has not occurred to date.
 
Event Description
On (b)(4) 2013 product analysis was completed on the lead. During the visual analysis of the returned 47mm portion quadfilar coil 1 appeared to be broken approximately 12mm and 14mm from the end of the cut inner silicone tubing. Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 12mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 14mm) and identified the area as having evidence of being worn to the point of fracture which prevented identification of the coil fracture type with fine pitting. Flat spots and pitting were observed on the coil surface. During the visual analysis of the returned 58mm portion the (+) white electrode quadfilar coil appeared to be broken at the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed and identified the area as having extensive pitting and mechanical damage which prevented identification of the coil fracture type. 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. With the exception of the observed discontinuities, 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 setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Product analysis on the generator was completed on (b)(4) 2013. Review of the data indicated that the pulsedisabled byte was set to a value that represents a vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3050791



Title: Re: New Seizure Type
Post by: dennis100 on May 08, 2018, 02:19:36 AM
Model Number 105
Event Date 08/24/2013
Event Type  Injury   
Event Description
It was reported that the patient experienced a longer than usual seizure. The patient reported that she experienced a seizure today that lasted approximately a minute and a half and that swiping the magnet did not stop the seizure. The patient reported that since the vns was programmed on her seizures were reduced to 10-20 seconds at most until this seizure. No additional information has been received to date.
 
Manufacturer Narrative

Event Description
Further follow-up revealed that the patient was first seen by the physician on (b)(6) /2013. The patient reported a history of experiencing seizures twice a month. It was reported that a new grand mal type seizure was reported. The grand mal was occuring every week or so. The physician chose to increase the patient's zonisamide dosage. After this visit, the patient called the office on (b)(6) 2013 to report another grand mal. The physician increased the zonisamide again, and at the next visit on (b)(6) 2013 the patient reported seizure activity was back to her normal twice a month. There was no report of any grand mal type seizures. On the (b)(6) 2014, a new medication type was introduced and the seizure control was reported as improving. The patient was last seen on (b)(6) 2014. At this visit no adjustments were made to the vns device, and the settings remained at 1. 0/25/200/14/1. 8.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3360682


Title: Re: New Seizure Type
Post by: dennis100 on May 10, 2018, 01:01:00 AM
Model Number 302-20
Event Date 08/30/2013
Event Type  Malfunction   
Event Description
Clinic notes dated (b)(6) 2013, indicate the patient experienced an increase in seizures likely due to the high impedance on the vns. Seizure frequency is reported as six to eight per day, or twenty to thirty per month. The vns device was turned off due to the high impedance and vns replacement surgery is being considered. Per the patient's vns continues to work well for the patient and the family still feels that swiping the magnet is helpful. The patient continues to have two seizure types and had decreased his seizures to one to four seizures every few days (may cluster four to eight a week). These are all tonic seizures. The seizures are preceded by an attempt to find comfort. In the past two months, a drastic increase in diastat use was noted. Increased keppra has helped in the past and stopped a new seizure type in (b)(6). The seizures are worse in the morning and sometimes a cluster may get close to five minutes. The keppra medication was increased and lamictal dose stayed the same. Although the clinic notes indicate that the same seizure frequency is both an increase and decrease, follow up with the nurse verified that the patient did experience an increase in seizures related to the high lead impedance. The nurse stated that the decrease in seizures to one to four seizures every few days was written in clinic notes dated (b)(6) 2013. Diagnostics were within normal limits at that time. Per the mother, the patient did not have any trauma or manipulation of the leads and had not sustained any falls that may have caused the high lead impedance. There were no causal factors for the increased seizures except the high impedance. The nurse was unable to distinguish the patient's increased seizure frequency to pre-vns baseline levels. The patient had a ches x-ray on (b)(6) 2013 which showed no abnormalities in the visualized portion of the lead. The x-rays will not be sent to the manufacturer for review. Although surgery is likely, it has not yet occurred.
 
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. 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=3381597


Title: Re: New Seizure Type
Post by: dennis100 on June 08, 2018, 02:58:31 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 04/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient's mother reported that the patient has had cluster seizures including grand mal seizures which is new for the patient. The magnet was stated to not be working for the patient. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7544128


Title: Re: New Seizure Type
Post by: dennis100 on June 11, 2018, 12:37:27 AM
Model Number 103
Event Date 07/01/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Clinic notes dated(b)(6) 2013 note that the patient experienced an increase in seizures to five seizures a week. Clinic notes dated (b)(6) 2013 note that the patient experienced four seizures per week. Clinic notes dated (b)(6) 2013 note that the patient has experienced a change in seizure semiology of drop attacks. The relationship of the increase and change in seizures to vns therapy is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4327046


Title: Re: New Seizure Type
Post by: dennis100 on July 06, 2018, 08:45:57 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 11/01/2017
Event Type  Injury   
Event Description
It was reported via clinic notes received that the patient's vns generator battery was depleted. It was questioned "why new seizures. " it was unclear if this was the report of a new seizure type or an increase in seizures. Follow up with the company representative revealed that at the most recent clinic visit, the patient's vns was interrogated and found to be at an end of service, or eos, condition and pulse disabled. The last data in the manufacturer's database was from approximately a year and a half prior to the recent clinic visit. It was unknown what physician, if any, had been managing the patient's vns as the submitter of the clinic notes only managed the patient's seizures and medications, not the vns. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7640091


Title: Re: New Seizure Type
Post by: dennis100 on August 10, 2018, 04:03:34 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/10/2017
Event Type  Injury   
Event Description
Clinic notes were received for patient referral for replacement. Notes state that the patient¿s thrashing seizures are new and needs new vns. His vns was noted to be dying an in the zone where it should be replaced based on battery life indicator (likely ifi-yes). Follow-up with the physician showed that the physicians were not clear what the cause of the new seizure type that was stated in notes in october was. They were not sure if the thrashing was a new seizure type of not and what the cause was including vns therapy. No diagnostic history was able to be provided. The patient's generator was replaced however the device is not available for return. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7712015


Title: Re: New Seizure Type
Post by: dennis100 on October 06, 2018, 06:01:16 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/13/2016
Event Type  Injury   
Manufacturer Narrative
 
Event Description
The patient's mother reported that the patient is now experiencing cluster seizures which they have not previously experienced. Multiple attempts for relevant information were made, but no relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7859645


Title: Re: New Seizure Type
Post by: dennis100 on November 05, 2018, 11:30:09 AM
Model Number 103
Event Date 11/12/2012
Event Type  Injury   
Event Description
On (b)(6) 2012 it was reported that the vns patient had 10-12 seizures that morning, approximately 10 head drops with loss of all muscle control which was something new, one focal seizure lasting 3-4 minutes where the patient collapsed in the bathroom, and one grand mal lasting 6 minutes. The patient called 911 and had swiped the vns magnet about 10 times which stopped the focal seizure but not the grand mal seizures. The patient was also given 7. 5mg diastat as he did not have a 10mg portion at the house. The patient was noted to have been ill the last 2-3 weeks with the flu and then had vomiting, but the patient stated that the last time he was sick was on (b)(6) 2012 and he has not had any missed medications. The patient was now also having bradycardia. The physician's office later reported that since the patient was given diastat due to his increase in seizures, this caused the bradycardia. Diastat caused the heart rate to drop; the bradycardia was a side effect of diastat and not related to vns. Attempts for further information from the physician are underway but no additional information has been received to date.
 
Manufacturer Narrative
 
Event Description
Additional information was received on (b)(6) 2013 when the manufacturer's consultant stated that the only information that the physician¿s office was able to provide was that the incident was on (b)(6) 2012 and the patient was given ativan and diastat which is what caused the bradycardia. The bradycardia didn't have anything to vns; it was due to the patient's medication - diastat and ativan. The patient's settings were noted to be output=1ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=1. 5ma/magnet on time=60sec/magnet pulse width=250usec and then the patient came back in on (b)(6) 2012 and they increased the output current to 1. 25ma and magnet output to 1. 5ma, the rest of the settings stayed same. The office again reiterated that the event did not have anything to do with vns. No further information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2861715


Title: Re: New Seizure Type
Post by: dennis100 on November 10, 2018, 02:44:11 AM
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/23/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient was experiencing drop seizures (in which the patient would fall), which the patient did not experience prior to vns implantation. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7995481


Title: Re: New Seizure Type
Post by: dennis100 on November 28, 2018, 02:17:00 AM
Model Number 102R
Event Date 03/10/2010
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 indicated that at the age of (b)(6), the patient started experiencing a second type of seizure that was different from the usual ones. They were of an unknown etiology factor, last approximately 1 minute, occurring 2 to 3 per day, and occur when awake. The patient becomes completely unresponsive, loses awareness, eyes are staring. No automatisms, no stiffening posturing, no tongue or cheek bites, no incontinence. Patient has falling secondary to the seizures. The relationship of the new seizures to vns has been unsuccessful to date. Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Manufacturer Narrative
Previously submitted mdr inadvertently did not provide the correct product information for the suspect device involved in the event.

Event Description
Additional information was received stating that the vns patient¿s seizures were milder after device settings were increased and the patient¿s change in seizure pattern is expected for vns responders. The patient¿s device was tested and showed normal device function.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4008513


Title: Re: New Seizure Type
Post by: dennis100 on January 16, 2019, 02:44:49 AM
Model Number 102
Event Date 01/01/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2014 note that the patient's seizures are fifteen times a month and last two to three minutes. It was noted that the patient experienced an increase in seizures in (b)(6) 2013 with two seizures for over a week. The physician increased the device output current to 2ma and the patient became seizure free again. The notes indicate that the patient has experienced more frequent seizures that have changed in character. It was noted that there have been no recent medication changes. Clinic notes dated (b)(6) 2014 note that the patient's seizures are every other day and are shorter and less impairing. The assessment notes that vns placement and rufinamide have helped seizures, but she continues to have approximately 8 complex partial seizures per month. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Additional clinic notes were received. The clinic notes report that shortly after the vns surgery (in (b)(6) 2013), the patient had a different seizure presentation. Patient stares and patient¿s head will often slump down. No arm movement was observed. These were happening once per day at various times, lasting about 3 min each time, and started shortly after her surgery. The clinic notes also report that from (b)(6) 2013, the vns current was at 1. 5ma and the patient had several auras but no seizures. Then the vns was increased to 1. 75ma on (b)(6) 2013 and the patient had 1-2 seizures per day from (b)(6) 2013 so the vns was decreased back to 1. 5 per the parent¿s requests. Additional information was received from the neurologist that there were no medication changes that could have caused or contributed to the new seizure type. Per the physician, the new seizure type is not likely related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3790928


Title: Re: New Seizure Type
Post by: dennis100 on February 11, 2019, 02:24:45 AM
Model Number 106
Event Date 11/01/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on 11/07/2016 that the patient is experiencing an more intense seizures including new drop seizures. She is having some drop seizures which she had not had in the past. There were no other factors that were thought to have caused the increase or new seizure type except a medication change which was a drop in topamax from 7. 25 mg tablets to 6 mg tablets. Patient would not sit still long enough to run diagnostics.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6143223


Title: Re: New Seizure Type
Post by: dennis100 on February 16, 2019, 02:46:12 AM
Model Number 104
Event Date 02/23/2015
Event Type  Injury   
Event Description
It was reported that a patient experienced ataxia and had visited the er regarding this following a vns generator replacement surgery. The attending neurologist did not believe this incident to be related to vns and further added that the patient had subclinical seizures and not ataxia. Additional information was received stating that the exact time when patient began having the subclinical seizures is unknown and that it was presumed to be sometime after the vns generator replacement surgery. The subclinical seizures were reported to be a new type of seizure for patient. There were no recent medication changes and the only other change was the vns generator replacement. An assessment on the relation of subclinical seizures to vns therapy could not be provided. An eeg was performed and night time aed dosage was increased as interventions. Patient also started physical therapy for gait issues. Patient outcome was reported to be good as far as physician knew.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4617557


Title: Re: New Seizure Type
Post by: dennis100 on February 20, 2019, 12:14:36 PM
Model Number 300-20
Device Problem Unexpected Therapeutic Results
Event Date 04/01/2014
Event Type  Malfunction   
Event Description
Analysis of the explanted lead was completed on (b)(6) 2015. The reported allegation of high impedance was confirmed. Discontinuity of both the positive and negative quadfilar coils in the body region of the returned lead portions was observed. Abraded openings of both outer and inner tubing near the break locations were observed as well.
 
Manufacturer Narrative
Describe event or problem, corrected data: the supplemental report #2 inadvertently did not report the fluid leaks.
 
Event Description
It was reported that the vns patient was experiencing an increase in seizures and began having drop attacks which were reported to be a new seizure type for the patient. Magnet mode stimulation was also no longer effective in aborting the patient¿s seizures. It was noted that the patient¿s medications were being adjusted. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2010. A battery life calculation using the available programming history showed approximately 2. 6 years remaining. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
It was reported that the patient underwent vns lead and generator replacement on (b)(6) 2015. The reason for replacement was due to neos=yes and high impedance. The explanted lead and generator were received on (b)(6) 2015. Analysis of the lead is underway, but has not been completed to date. Analysis of the explanted generator was completed on (b)(6) 2015. The reported end-of-service allegation was not duplicated in the laboratory. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.
 
Event Description
The abraded openings and slice mark found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4719016


Title: Re: New Seizure Type
Post by: dennis100 on March 09, 2019, 03:34:21 AM
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/31/2019
Event Type  Injury   
Event Description
It was reported by the patient that they had experienced a different, more intense, type of seizure than normal. The patient described the seizure event as "from nothing to a very significant one" and "going from 0 to 1000" as opposed to his typical gradual seizures. The patient reported that after the varied seizure he became more aware of his stimulation and the side effects with stimulation that he had experienced with titration (discomfort and cough) came back. No further relevant information has been received to date.
 
Manufacturer Narrative
Patient problem: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8371572


Title: Re: New Seizure Type
Post by: dennis100 on April 07, 2019, 03:16:18 AM
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/16/2019
Event Type  Injury   
Event Description
It was reported from the patient¿s mother that he was having some troubles. The patient had a recent full replacement in january and now patient has had some adverse events. States was seen by pcp who started antibiotics and found inflammation in throat and both ears. Patient had "szs on and off all day", much different than his normal episodes, with actual convulsions and 15 min postictal period where he would sleep. It appears that the issues may be related to the recent surgery and that the seizures may be side effects of the medications provided but no additional information has been received to date for clarification.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8433681


Title: Re: New Seizure Type
Post by: dennis100 on April 08, 2019, 02:36:29 AM
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/18/2019
Event Type  Malfunction   
Event Description
It was reported that a patient used his magnet and he dropped to his knees and then went into a grand mal seizure. He has not used his magnet since his implant last july. He typically has absent seizures and has not had a grand mal seizure in many years. He was curious if the magnet activation actually caused him to have a grand mal seizure. He did mention that he started having absence seizure clusters prior to the grand mal seizure. His wife informed him that he got completely stiff solid like a board for about 20 seconds. They have never witnessed him having this type of seizure. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8422767


Title: Re: New Seizure Type
Post by: dennis100 on April 11, 2019, 10:11:26 AM
Model Number 102
Event Type  Injury   
Event Description
It was reported that the vns patient has new small seizures and balance disorders in addition to his usual seizures. No end of service flag was seen during interrogation. A battery life calculation using the available programming history showed approximately 4. 6 years left until near end of service is yes. Additional information was received from the physician with all data regarding the patient's follow-up records since the vns implantation in (b)(6) 2012: on the visit 1 in (b)(6) 2012, the device was programmed at 0. 25ma output current - 250¿sec pulse width - 20hz frequency - 30sec on time and 5min off time. No special adverse event was and everything was ok. On the visit 2 in (b)(6) 2013, the patient was stable. He has spent 1 week without seizure (after vns activation) which is rare. He had some seizures during the (b)(6) period. The output current was increased at 0. 5ma. On the visit 3 in (b)(6) 2013, it was found that the patient's seizures increased a little in 2 months. The parents reported dysphonia and small cough but the patient's mood had improved well. The output current was increased to 0. 75ma without any adverse event. No cough was noted. On the visit 4, it was reported that the patient spent 9 days without seizures. The vns stimulation was well tolerated but some episode of cough was reported. The output current was increased to 1ma. System diagnostics returned impedance results within normal limits. On the visit 5, some episode of fever was reported (but not more than 38°c). The cause was unknown but, as reported by the physician, this is a known event to encephalopathic patients with lennox gastaut syndrome. No infection occurred. The output current was increased at 1. 25ma. On the visit 6 in (b)(6) 2013, it was reported an increases in seizures but not intense. It was reported that this could be related to patient's emotions. The output current was increased at 1. 5ma. On the visit 7 in (b)(6) 2013, frequent seizures were noted but not intense. It was reported by the caregivers that the vns magnet was more used because it stops immediately 80-90% of seizures. The output current was modified to 1. 75ma and the frequency was increased to 30hz. On the visit 8 in (b)(6) 2013, the patient seizures frequency was stable and not intense. No voice alteration and cough were reported. The output current was increased at 2ma and the pulse width to 500¿sec. On the visit 9 in (b)(6) 2013, it was noted that the patient mood and behavior were improved well. But it was reported that the patient had one big seizure and fall. Small tonic seizures were noted too. The output current was changed to 2. 25ma. On the visit 10 in (b)(6) 2014, the physician reported that a positive evolution of the situation was noted. A small cough was reported. System diagnostics returned impedance results within normal limits. The duty cycle was changed by modifying the off time from 5min to 3min. On the visit 11 in (b)(6) 2015, a progressive increase in seizures was noted during the past 7 months. No change in medications was performed. It was reported by the physician that this could probably due to the modification of duty cycle (from 5 to 3min off time). The physician decided to change back the duty cycle to the initial settings. System diagnostics returned impedance results within normal limits. On the visit 12 in (b)(6) 2015, it was reported that since the duty cycle was modified back to initial settings, an improvement was noted; seizure reduction was noted. It was reported that the patient was still sensible to emotions. System diagnostics returned impedance results within normal limits. Vns device was functioning perfectly. On the visit 13 in (b)(6) 2016, it was reported that since (b)(6) 2015 the patient had more seizures. It was reported that on (b)(6) 2016, the patient had a big seizure and fall. That day, he had pallor, muscle spasms, brief respiratory arrest and wound on eyebrow which was treated by antibiotics. It was reported that the patient had later 2 other big unusual seizures: they were generalized tonic chronic seizures. System diagnostics returned impedance results within normal limits. Vns device was functioning perfectly. The output current was changed to 2. 75ma. On the visit 14, on (b)(6) 2016, the patient was seen for a follow-up of lennox gastaut syndrome. Eeg was ok with some improvement. It was reported that the patient had ambulation difficulties and fall; he could not stay up for a long time. An increase of hemiparesis was reported. Nevertheless, patient's seizures reduction was noted. The vns stimulation was well tolerated. System diagnostics returned impedance results within normal limits and the near end of service flag was no. It was reported that the last vns parameters were at 2. 5ma output current ¿ 30hz frequency ¿ 500¿sec pulse width ¿ 30sec on time ¿ 5min off time. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5789779


Title: Re: New Seizure Type
Post by: dennis100 on May 03, 2019, 01:54:16 AM
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/25/2011
Event Type  Injury   
Event Description
It was reported via clinic notes that a vns patient was experiencing an increase in seizures. The patient was referred for surgery. The physician stated the generator was interrogated and confirmed the device "is functioning well". Follow-up from the patient on (b)(6) 2017 also provide that she has had issues with different seizure types and frequency since last replacement. She stated seizures now happen every 2 weeks when they were happening every 4-5 weeks, lasting up to 2. 5 minutes and her recovery can be up to a week. Follow-up from the physician provided that the most recent diagnostics were normal with no error and the device was not at end of battery life. The patient¿s husband has reported increasing seizure frequency and severity past 3-6 months. The physician provided it is unclear if the increase in seizures was related to vns and mentioned the device is likely needing replacement. There is high suspicion for non-epileptic seizures co-existing with her epilepsy. Battery status indicator was reported to be normal. The change in seizure pattern and post-ictal duration is unclear if it is related to vns. It is suspected that the patient has pnes (psychogenic non-epileptic seizures) as well. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the patient provided that she was still experiencing seizures and that she can no longer feel the magnet swipe.
 
Event Description
Follow-up from the patient provided that the generator has migrated close to her armpit due to her weight loss and is bothersome. The patient reports that she has had increased seizures within the last year and does not feel the vns is working. The patient also stated she had a really rough week as she has had a lot of seizures.
 
Event Description
It was reported by the patient that her device was turning on every 10 seconds, and staying on for about 10 seconds. The stimulation was very strong and painful and making it difficult to swallow. She reported that generator location makes it difficult to access with the magnet to disable the device. It was indicated by the surgeon that the patient's replacement surgery was due to battery depletion and her migration would be fixed at this time. Per the surgeon, the surgery was not to preclude a serious injury. No surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
It was reported that the patient underwent replacement due to battery depletion. The explanted product was returned. The patient reported that she had been having sleep apnea, buzzing in her neck during sleep since 2011. She also indicated that she had felt stronger stimulation in her neck and that she gagged with magnet swipes which had led to weight-loss in the past. The patient's treating physician indicated that this patient was a high anxiety patient. It was found that the patient had multiple complaints requiring investigations of increased seizures, pain with stimulation, dysphagia with stimulation, and perception of stimulation since 2011 that were previously considered separate events. Three reports regarding seizures of this patient were submitted since 2011. In mfr. Report #1644487-2012-00443, the patient reported that she'd had an increase in seizures in january 2012, a tightness in her neck, a decreased range of motion of her neck, and pain and clicking in her throat with stimulation. The physician said that the patient's increased seizures were not related to vns. The physician stated that he believed that the patient¿s pain and ¿tightness¿ or limited range of movement, were psychiatric in nature and not related to vns. In (b)(6) 2015, mfr. Report #1644487-2015-04964, captures a report from the patient that she had a new type of seizure while having her vns settings adjusted. This seizure was later indicated not to be related by the physician and the physician indicated that the patient's seizures had decreased in severity since having the vns. Mfr. Report #1644487-2015-05446 reported that in (b)(6) 2015 the patient had experienced an increase in seizures due to her "levels being low. " the physician indicated that the patient had an extremely variable seizure pattern and that her history is not reliable. Further relevant information to these reports will be captured in the current manufacturing report as these reports appear to be related. No further relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: supplemental mdr 4 inadvertently reported that the generator was returned when it was actually discarded.
 
Event Description
The physician indicated that the relationship of the following symptoms---sleep apnea, buzzing in neck, stronger stimulation in her neck, and gagging with magnet swipes which had led to weight-loss in the past--- was unknown. The patient's explanted product was discarded. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6434722


Title: Re: New Seizure Type
Post by: dennis100 on May 03, 2019, 01:55:10 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported by the patient's mother that the patient had an increase in seizures. The patient's device was disabled due to the increased seizures. The patient recently started having another increase in seizures, so a new physician turned the patient's vns back on as the last treatment option because medication is not controlling the patient's seizures. The physician believed that the patient's seizure type was changing, and the seizures had been getting worse over time with no specified start date. Diagnostics were not performed. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6441687


Title: Re: New Seizure Type
Post by: dennis100 on May 05, 2019, 12:59:43 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported that the patient was experiencing nausea and unspecified symptoms of battery depletion, according to the patient's mother. It is unclear if the nausea is related to vns. The patient was scheduled for surgical consult as the patient's battery was at neos = yes as of a clinic visit three weeks prior.
 
Event Description
It was reported that the physician was unaware of any nausea that the patient was experiencing and as such, could not provide its cause. The physician did not suspect the nausea was related to vns. The patient also began experiencing a change in seizure type that he believes was possibly associated with the battery depletion. The patient underwent generator replacement surgery. The product was disposed of after surgery and is unavailable for analysis. No additional information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6433995


Title: Re: New Seizure Type
Post by: dennis100 on May 07, 2019, 07:36:35 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2016
Event Type  Malfunction   
Event Description
It was reported that the patient believed her vns battery was dying because she experienced an increase in seizures. The patient also reportedly had a seizure with a convulsion, which was stated to have never been experienced by the patient before. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6393405


Title: Re: New Seizure Type
Post by: dennis100 on May 20, 2019, 09:39:56 PM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
It was reported that the patient's seizures are not controlled and that the patient is having more seizures with her vns than she did previously. Patient also reported that her seizure type has changed. She is now having seizure clusters instead of on-off seizures. This has reportedly been occurring for about a year now. Device was checked few weeks prior to the report and all of the diagnostics were normal at that point. Patient is considering having the device removed since it hasn't been helping her seizures. Patient was referred to see surgeon for explant consult. No relevant information was obtained regarding the patient's seizure control. No adjustments in dosing were made at this appointment. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6562929


Title: Re: New Seizure Type
Post by: dennis100 on June 04, 2019, 08:29:52 AM
Model Number 103
Event Date 01/01/2014
Event Type  Injury   
Event Description
It was reported that the patient began experiencing grand mal seizures about six moths prior. It was reported that the patient had never experienced a grand mal seizure prior to this. The patient reported that he previously only experienced petit mal seizures. The patient is scheduled to be seen by the physician, but has not been seen to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3910742


Title: Re: New Seizure Type
Post by: dennis100 on June 07, 2019, 05:20:38 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/05/2019
Event Type  Malfunction   
Event Description
Patient reported on social media that her seizures were getting worse and that she was getting seizures that were a different kind as well. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8575521


Title: Re: New Seizure Type
Post by: dennis100 on June 08, 2019, 06:12:08 AM
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/12/2019
Event Type  Injury   
Event Description
It was reported that the patient recently developed more frequent, possibly different type seizures. The patient's generator was replaced. The suspect product has not been received to date. Multiple attempts for additional information regarding the patient's seizures were made; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8632499


Title: Re: New Seizure Type
Post by: dennis100 on June 23, 2019, 03:57:12 AM
Model Number 102
Device Problem Insufficient Information
Event Date 05/05/2015
Event Type  Injury   
Event Description
It was reported that the patient experienced an unusual seizure during device settings adjustments; therefore, the physician left the settings as previously programmed. The patient reported that the seizure was different than what she was used to. Attempts to obtain additional relevant information have been unsuccessful to date. The relationship of the unusual seizure to vns is unknown.
 
Manufacturer Narrative

Manufacturer Narrative
The previously submitted mdr inadvertently provided an incorrect event date.
 
Event Description
Information was received from the neurologist via a company representative on (b)(6) 2015. The date of onset of the new seizure type was (b)(6) 2015. The patient's seizures are less severe since vns. The new seizure type is not related to vns, but is related to external factors. No interventions were planned or taken. Diagnostic results were not reported.
 
Event Description
Further reports regarding this patient's increased seizures were received and this and all further relevant information regarding this event will be captured mfr. Report # 1644487-2017-03470.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4860270


Title: Re: New Seizure Type
Post by: dennis100 on June 28, 2019, 11:05:03 PM
Model Number 105
Event Date 05/12/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the patient had complaints of redness, swelling, and pain at the vns generator site. The physician programmed the vns off and referred the patient back to the ent for evaluation of the site for infection. Additionally information was received which stated the patient also believes the generator is heating and not working. The patient stated he has had an increase in seizures as well as a change in seizure type. Later it was reported the physician does not feel the patient's symptoms were related to vns, but believed it was a "nerve issue". It is unknown what the nerve issue is, or what may have caused the nerve issue to occur. A x-ray assessment was provided by the physician which stated "gross satisfactory vagal nerve stimulator. No acute finding". Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Clinic notes were received due to re-implant surgery referral due to a "problem with the vagus nerve stimulator". It was mentioned in the notes that the patient was still having seizures. The patient's replacement occurred on (b)(6) 2016 and it was noted he was switched from a model 105 generator back to a model 102 generator. After the generator was replaced with the new generator, the system diagnostic results confirmed the device was working as intended. It was reported by the physician's office that the patient was last seen on (b)(6) 2016 and had mild pain, redness, and 4 seizures. It was confirmed that these seizures have increased from her baseline. It was noted that an additional event had occurred which lasted for hours and the patient felt heating around the vns device. There was not reason specifically given for the increase in seizures. It was noted that the vns settings on (b)(6) 2016 were at therapeutic levels and the diagnostics were within normal limits. It was noted the device would not be returned per hospital regulations. It was further reported by the company representative who was at the surgery that the m105 was "faulty" and needed to be replaced, or per patient request, would be removed completely. The patient requested to have a 102 as he did not have any issues with the m102. Per the patient and the surgeon, the believed cause of the burning sensation and irritability was due to the 105 generator. According to the patient, the burning sensation occurred immediately after the 105 settings were adjusted, but continued even after the device was programmed off. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5726096


Title: Re: New Seizure Type
Post by: dennis100 on July 26, 2019, 01:15:34 AM
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by the patient that she believes she needs a vns replacement due to her seizures getting worse and having changed. The patient stated she was in the icu for 4 days with seizures. The patient had not seen a neurologist and was looking for a recommendation to see one however no neurologist appointment is known to have occurred. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7916429