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Author Topic: Atonic Seizures  (Read 75954 times)
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dennis100
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« Reply #120 on: October 21, 2017, 01:11:17 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
« Last Edit: May 14, 2018, 08:46:10 AM by dennis100 » Logged
dennis100
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« Reply #121 on: October 24, 2017, 01:13:52 AM »

Model Number 103
Event Date 08/01/2013
Event Type Injury
Event Description
The physician reported that the previous saturday during follow up of the patient, the mother informed him that the patient had showed an aggressive behavior and the situation was related to the vns, because the patient had not exhibited this behavior prior to being implanted with vns. The physician further reported that the atonic seizures also increased three months ago. The physician adjusted the medication and added risperidone three months ago, but did not get control over the patient's seizures and the behavior is going worse. No additional information has been provided.

Manufacturer Narrative
Adverse event and/or product problem, outcomes attributed to adverse event, type of reportable event, corrected data: the initial manufacturer report inadvertently reported the incorrect event type. This report is being submitted to correct this data.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3533638
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« Reply #122 on: November 26, 2017, 03:23:16 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
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dennis100
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« Reply #123 on: December 07, 2017, 02:08:29 AM »

Model Number 103
Device Problem No Information
Event Date 11/11/2015
Event Type Injury
Event Description
Product analysis on the explanted vns generator was completed. During analysis, the device output signal was monitored for more than 24-hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the vns generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The ifi = yes (intensified follow-up indicator) condition was duplicated in the lab. There were no performance or any other type of adverse conditions found with the vns generator. No additional relevant information has been received to date.

Event Description
It was reported the patient's replacement surgery occurred on (b)(6) 2015. The explanted generator is expected to be returned for analysis; however, the device has not been received by the manufacturer to date.

Event Description
It was reported through clinic notes that the patient is having multiple drop seizures per day and myoclonic seizures at the onset of sleep. It was noted by the mother this was an increase in seizures. The generator was found to have the intensified follow-up indicator set (ifi) to and ifi = yes condition. Impedance was checked and noted to be within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5289661
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dennis100
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« Reply #124 on: January 04, 2018, 02:08:19 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that on (b)(6) 2016 when the generator was programmed back on the patient slept all day. The patient was reportedly did not have any cardiac events after the generator was programmed on until (b)(6) 2016 when he lost consciousness for approximately 5 minutes. The holter monitor personnel did not notify the patient's caregivers that this event was asystolic. The patient then presented for a follow-up appointment where system diagnostics were found to be within acceptable limits and the vns was left programmed on. However the patient suffered another event on (b)(6) 2016. This time the caregivers were informed by the holter monitor personnel that this event was asystolic. The monitor recorded that the patient was in asystole for 14 seconds during the event. The physician then decided to program the generator off. No additional relevant information has been received to date.

Manufacturer Narrative
This information was inadvertently left off on mfg. Report #1.

Event Description
Further follow-up found that the physician believed that the patient had an unusual heart rhythm pattern not associated with medication. The unusual rhythm ceased after the vns was turned off and it was reported that patient was doing fine after medications were resumed without vns therapy. Based on the information available it appears that the there may be a relationship between the cardiac events and vns therapy. Vns therapy in combination with medications could be contributing to the cardiac events however it is unclear at this time. As previously reported, diagnostic testing has shown that the vns generator is functioning normally and the battery is not depleted. Therefore it does not appear that a malfunction is occurring. Cardiac events are a known potential adverse event associated with vns therapy which is discussed in labeling.

Event Description
It was reported that the patient began experiencing episodes of syncope starting in (b)(6) 2016. The patient was originally implanted with a vns device in 2004 and the most recent generator replacement occurred in (b)(6) 2012. No syncope or cardiac events were reported with previous vns devices. During the syncopal episodes, the patient felt dizzy and light headed. He would see black spots in his vision and complained of heart palpitations. During three of these episodes he lost consciousness and one of these episodes resulted in the patient going to the emergency room. At that time the vns settings were reduced and the daily dose of lamictal was increased. The patient was evaluated by the physician in (b)(6) 2016, however there were no reports of cardiac or syncope events. The patient did report experiencing an increase in seizures due to stress. The physician then increased the vns settings and again increased the daily dose of lamictal. In (b)(6) 2016 it was noted that the patient was suffering from drop attacks where he would have a staring spell then he would quickly fall to the ground. It was noted that the drop attacks decreased after the patient started a low dose of phenobarbital. An extra dose of phenobarbital was added later added. The vns settings were reduced and the lamictal dose was again adjusted. The drop attacks continued and an attack at the end of the (b)(6) 2016 resulted in the patient going to the er where he was admitted. During the admittance a holter monitor was used to confirm that the patient was going into sinus bradycardia followed by asystole that could last up to 14 seconds followed by difficulty with any type of ventricular reentry. The physician decided to disable the vns device on (b)(6) 2016 and kept the medication levels unchanged, though the reason for this change was not provided. It was noted on (b)(6) 2016 that the patient did not experience any syncope episodes during the previous 4 days. This led the physician to be concerned that the syncope events may be related to vns therapy. The vns device was then programmed back on at a lower setting on (b)(6) 2016. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6142575
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dennis100
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« Reply #125 on: March 09, 2018, 04:08:10 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
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dennis100
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« Reply #126 on: March 28, 2018, 02:07:03 AM »

Model Number 102R
Event Date 10/01/2013
Event Type Injury
Event Description
Additional information was received which found that the increase in seizures was first observed in (b)(6) 2012. The physician stated that he thinks the vns battery died out and that this caused the patient to have the breakthrough seizures. The vns was replaced on (b)(6) 2012 as an intervention. In regards to the relationship between the increased seizures to pre-vns baseline levels it was stated that there was none. The patient was said to have more atonic or drop seizures. Medication changes also occurred when the seizures were getting worse which may have caused or contributed as well. The patient was last seen on (b)(6) 2013. During this visit, the physician stated that the patient's intractable generalized epilepsy had improved, meaning the patient's seizures had improved per the nurse. No other information was provided. No diagnostics were known.

Manufacturer Narrative
Serial number, corrected data: initial mdr inadvertantly listed the incorrect serial number.

Event Description
Follow up with the physician's nurse found that it was unknown when the increase in seizures first occurred, except that it was prior to (b)(6) 2012 when the patient's battery was replaced. Diagnostics were taken on (b)(6) 2012 when the patient was admitted to the hospital for an eeg (electroencephalography); however, the results were unknown. The nurse did not know what the relationship of the increased seizures was to vns or what the relationship was to pre-vns baseline levels. It was stated that the physician may have additional information; however, attempts for this information have been unsuccessful. No additional information has been provided.

Manufacturer Narrative

Manufacturer Narrative
Event date, corrected data: previously submitted mdr indicated an incorrect event date. This report is being submitted to correct this field.

Event Description
On (b)(6), 2012, the surgeon stated that the patient would have an emergency battery replacement on (b)(6), 2012 due to an increase in seizures. It was reported that their battery was at near end of service. It is unknown what the relationship of the increased seizure frequency is to pre-vns baseline levels. It is unknown if the patient's generator was able to deliver their therapy related to the battery status. The explanted generator will not be returned per hospital policy. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2880616
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dennis100
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« Reply #127 on: March 30, 2018, 02:58:17 AM »

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
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dennis100
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« Reply #128 on: April 01, 2018, 01:55:49 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
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dennis100
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« Reply #129 on: June 09, 2018, 02:06:52 AM »

Model Number 300-20
Device Problem No Known Device Problem
Event Date 01/01/2018
Event Type  Injury   
Event Description
Clinic notes were received for patient's generator and lead replacement. Notes indicate that the patient's device was disabled in the past but the magnet is still enabled. Magnet is not used much because of the seizure duration being brief. But the caregivers wonder if the vns is shorting. Notes also indicate that the stimulation triggers drop attacks for patient. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7506778
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dennis100
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« Reply #130 on: November 10, 2018, 04:16:30 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
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dennis100
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« Reply #131 on: November 11, 2018, 02:49:23 AM »

Model Number 102
Event Date 12/01/2010
Event Type  Injury   
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.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2720243
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« Reply #132 on: November 15, 2018, 08:57:54 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3121521
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« Reply #133 on: December 29, 2018, 04:36:45 AM »

Model Number 103
Event Date 01/06/2015
Event Type  Injury   
Event Description
It was reported that the vns patient experienced a drop attack and blacked out following a magnet swipe. It was noted that this seizure type was not typical for the patient. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Manufacturer Narrative

Event Description
Additional information was received that the patient's reported episode is not a new seizure type, unknown cause for episode (drop attack with lips turning blue). No interventions were taken. Medications taking at the time of the event. Depakote-6. 25 mg bid / fycompa 8 mg qhs / zonisamide-150 mg qhs / banzel 17. 5 ml in am, 3. 5 ml in afternoon , 7 ml evening / onfi-5 mg bid.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4483657
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« Reply #134 on: February 08, 2019, 01:31:14 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/12/2018
Event Type  Injury   
Event Description
It was reported that the patient has had two months of drop episodes. It is unknown if the drop episodes are seizures or are caused by syncope. It was also reported that when the patient was seen by cardiology, her heart rate decreased from 60 bpm to 40 bpm while stimulation was received when the patient was sitting. When the patient was standing, the heart rate decreased from 100 bpm to 80 bpm. Programming history was reviewed for the generator. No anomalies were seen. Device history records were reviewed for the generator. The device passed all specifications prior to distribution. The patient was referred to wear a holter monitor for 24 hours. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8214784
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« Reply #135 on: March 08, 2019, 02:12:09 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/13/2019
Event Type  Injury   
Event Description
It was reported that the day after patient settings were lowered for a dyspnea event, the patient began experiencing drop attacks and was admitted to the hospital. The device was checked and showed to be within normal limits. The patient was discharged from the hospital as he had returned to baseline frequency levels. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8317617
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« Reply #136 on: May 11, 2019, 02:12:38 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/18/2019
Event Type  Injury   
Event Description
Initial report was that a patient had 6 drop seizures and that the patient was referred for a prophylactic full revision of the vns (replacement of the lead and generator). Further information was received from the physician's office that the cause of the increase in seizures was unknown, but that the patient had missed some medications. The relationship of the increase in seizures to vns baseline levels was unknown. The patient was referred for full revision as a result of the increase in seizures. Clinic notes received for the patient indicated that the vns was reprogrammed. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8514466
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« Reply #137 on: June 10, 2019, 01:06:21 AM »

Model Number 102
Event Date 04/17/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, it was reported that the vns patient is having his vns removed as the battery is dead and the patient's seizures are controlled. Clinic notes dated (b)(6) 2012 were received on (b)(6) 2012 from a vns treating physician. The clinic notes stated that the patient's atonic seizures became so severe that they elected to have corpus callosotomy performed after the vns failed to provide the desired results. The patient's settings have been maintained at settings of 25hz/250usec/off time=1. 1. Min/on time=30sec/magnet output=2. 25ma. The patient's battery reached end of service more than 6 months ago and has stopped functioning according to the clinic notes. The vns could not be interrogated due to battery depletion. The patient's seizures are presently well controlled on depakote and lamictal. The clinic notes stated that the vns could be removed if the seizures remain well-controlled. A battery life calculation was performed which showed a negative amount of time remaining until near end of service. Attempts were made to the physician for further information but the only information received was that the patient had concerns that vns was not beneficial. No additional information was provided. The patient underwent generator explant on (b)(6) 2012. Attempts for product return are underway but the product has not been returned to the manufacturer for product analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2678627
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« Reply #138 on: August 10, 2019, 03:00:12 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/07/2019
Event Type  Malfunction   
Event Description
It was reported that the patient experienced an increase in drop seizures since vns implant surgery. It was reported that the patient was having up to 500 per day and that the drop seizures were well controlled prior to surgery. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8762936
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« Reply #139 on: August 10, 2019, 03:00:49 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/28/2019
Event Type  Malfunction   
Event Description
It was reported that a patient has been having drop seizures whenever the mother swipes the vns magnet and had a seizure when the physician interrogated the vns. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8799969
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