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dennis100
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« Reply #90 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
« Last Edit: May 14, 2018, 08:47:57 AM by dennis100 » Logged
dennis100
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« Reply #91 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
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dennis100
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« Reply #92 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
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dennis100
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« Reply #93 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
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dennis100
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« Reply #94 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
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dennis100
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« Reply #95 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
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dennis100
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« Reply #96 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
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dennis100
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« Reply #97 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

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dennis100
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« Reply #98 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
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« Reply #99 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
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« Reply #100 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
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« Reply #101 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
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dennis100
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« Reply #102 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
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« Reply #103 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
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« Reply #104 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
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« Reply #105 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
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« Reply #106 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
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« Reply #107 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
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« Reply #108 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
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« Reply #109 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
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« Reply #110 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
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« Reply #111 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
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« Reply #112 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
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« Reply #113 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
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« Reply #114 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
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« Reply #115 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
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« Reply #116 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
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« Reply #117 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
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« Reply #118 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
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« Reply #119 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
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