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dennis100
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« Reply #30 on: April 14, 2018, 01:23:02 AM »

Model Number 103
Event Date 11/01/2009
Event Type  Injury   
Event Description
It was reported that the pt was recently implanted and recently had his device turned on to 0. 25 ma output current and 0. 5 magnet output current. Per the pt, when he swiped his magnet, he turned blue and passed out. At the time of the report, the physician had not seen the pt since the episode and had no further information regarding the event. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1558272
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dennis100
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« Reply #31 on: May 01, 2018, 01:11:56 AM »

Model Number 102
Event Date 06/04/2008
Event Type  Injury   
Event Description
Initial reporter indicated that the pt was experiencing dyspnea with stimulation. Taping the magnet over the vns resolved the dyspnea. The pt had their vns programming adjusted a month earlier for painful stimulation and resolved but then started having the dyspnea with stimulation. All diagnostics were within normal limits. The pt reported an episode where she "stops breathing". The pt additionally reported neck "spasms". Reported "that it grabs at the neck and then results in her sweating, can't breathe, and heartbeat increasing. She's not sure whether the last three symptoms are due to the vns or due to her getting nervous about the grabbing. She feels like it paralyzes her neck where she can't get air down and her mom said she turned purple yesterday. It happens about once a day and using the magnet won't make it go away". The pt normally doesn't feel stimulation so did not know whether the neck spasm is during stimulation or not but it doesn't seem to occur every few mins. There was no report of any trauma or accident. X-ray review by mfr did not reveal any gross lead discontinuities or anomalies that may have contributed to the reported event. The pt underwent generator replacement surgery. During the surgery a large amount of scar tissue was noted around the pt's lead. Good faith attempts are being made for the prod return for analysis.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by mfr, no gross lead discontinuities or anomalies noted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1077469
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dennis100
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« Reply #32 on: May 03, 2018, 01:48:47 AM »

Model Number 103
Event Date 08/01/2011
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 that the patient has an oxygen monitor shows oxygen levels drop several times a day which may lead to the patient turning blue. The patient¿s jerks are not necessarily associated with these episodes. The patient had a reduction in the tonic episodes and the oxygen drops at the last visit, but he has had a significant increase in (b)(6) 2011. The seizures range from 673-1477. There was noted to be no obvious etiology for the increase in seizures since the recent ear infection for which he was given a medication for ear infections. On (b)(6) 2013, the patient¿s seizures (myoclonic and tonic episodes and staring) were noted to range from 362 and 916. ¿he has been very agitated for about two weeks. ¿ the patient¿s medication appeared to be helping the patient except the previous month, per the caregiver. On (b)(6) 2013, he had been on a medication for ear infections for 10 days. On (b)(6) 2013, the physician noted that given the number medications and doses, no medication dosing changes were made. The physician¿s impression in the notes showed that it is unclear whether the seizures are primarily generalized tonic episodes or secondarily generalized seizures. Follow-up was performed with the treating physician who assumed care for the patient after initial implant. He reported that he does not believe the increased seizures were related to vns in 2011 or potentially 2013. He was unable to say if it occurred in 2013, but the patient's seizures have never been under good control. He actually believes the patient has a very bad seizure disorder, and the reason the seizure are "34;out of control"; is due to bad respiratory compromise. "in other words, he has tracheostomy and bad lungs, and he has a lot of times when his oxygenation goes down. A lot of his seizures are related to that rather than other else. " the physician has been trying to get the patient monitored to correlate the relationship of the seizures and desaturation, but the monitoring has not occurred to date. He believes the patient's seizures are mostly caused by the desaturation. The relationship between the desaturation and sleep apnea to vns is unknown because he needs to be monitored via sleep study to see if saturation improves when the vns is turned off. The onset of the sleep apnea/desaturation is unknown. Diagnostics on vns were okay as far as the physician knows. He reported that the caregiver reported they want the vns replaced so the physician agreed. The patient has not exhibited any other symptoms that may be related to vns. He did not know the relationship of the increased seizures to pre-vns seizure frequency. This report captures the patient¿s increased seizures since the relationship of sleep apnea/desaturation to vns is unknown to date. Manufacturer report number 1644487-2013-02099-2013-02100 captures the desaturation and sleep apnea. The patient had generator replacement in 2009. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3224901
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dennis100
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« Reply #33 on: May 29, 2018, 02:52:37 AM »

Model Number 103
Event Date 03/01/2015
Event Type  Injury   
Event Description
It was reported that the patient has been hospitalized recently for various issues including seizures, coma, and pneumonia. Patient also experienced trauma when the paramedics had dropped patient on the floor. It was also reported that the patient had some issues with his vns. Additional information was received that the patient experienced seizure after seizures and later woke up to find himself at the hospital with a ventilation tube. Patient experienced pneumonia from the ventilator. When the ventilator tubes were taken out, it caused his throat to be sore and very sensitive. Patient¿s face was reported to turn purple with stimulation which was reported to have resolved on its own. Patient also experienced increased heart rate with stimulation following this incident. It is unknown if this event started recently after the hospitalization or if it was present before. Patient was recommended to visit the neurologist regarding this. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Additional information was received that the patient was having issues with throat closing and tachycardic episodes with stimulation (hr 130) with some recent change in settings on an unknown date. The patient's generator interrogated and found to be with settings of 1. 75/30/500/30/3. 0. The patient's frequency was lowered to 20 hz, which appeared to resolve the issue and the stimulation was still tolerable. At that time the physician was going to monitor the patient to ensure there were no other issues. The impedance was also confirmed to be 3115 ohms with no other issues with the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4698228
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dennis100
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« Reply #34 on: June 06, 2018, 01:57:58 AM »

Model Number 102
Event Date 02/13/2008
Event Type  Malfunction   
Event Description
It was reported to manufacturer that after the vns patient's device was interrogated at a routine office visit, the device output current was found to be a 2. 25ma, where the patient had previously been set to 0. 75ma. As a result of the high output current, the patient "grabbed her neck and was turning blue". The patient's device was interrogated using a different programming system and the settings were changed to the intentional settings. Attempts to obtain additional information from the treating physician have been made, but have been unsuccessful 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=1017637
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dennis100
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« Reply #35 on: July 06, 2018, 10:31:08 AM »

Model Number 1000
Device Problem No Known Device Problem
Event Date 05/14/2018
Event Type  Injury   
Manufacturer Narrative
Patient problem :1815.
 
Event Description
It was reported that a patient was just implanted with a m1000 device and the device was turned on to the lowest settings. It was stated that the patient was holding his breath and turning blue and aspirating and having a difficult time swallowing. The patient is non-verbal. The patient is also drooling more and choking on his spit. The np advised to go to the emergency room. They instructed the patient to turn device off by placing the magnet over it. The patient's diagnostics were good. The patient is tolerating current settings. It was stated that the believed cause of the issue was possible side effects due to being high risk patient. The patient's settings are going to be increased and the np will monitor the patient's progress. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7569735
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dennis100
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« Reply #36 on: September 19, 2018, 01:40:24 PM »

Model Number 102
Event Date 12/11/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was admitted to the hospital on (b)(6) 2011 for seizures. Patient's mother states she is having one seizure after another and is sometimes cyanotic during that time. She states she is in the icu and her doctors don't seem to know anything about her vns. It is unknown if the patient is currently seeing a neurologist or who it is, so no further information can be obtained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2429803
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dennis100
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« Reply #37 on: October 06, 2018, 06:28:31 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/27/2018
Event Type  Injury   
Event Description
It was reported that the patient was having painful stimulation after surgery. It was also reported that the patient was turning purple and coughing with every stimulation like they were choking. The physician subsequently turned the output and magnet currents down as well as turn the off time down from 0. 8 minutes to 3. 0 minutes. Information was received from the physician's office the doctor thinks the patient's settings were too high. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7899101
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dennis100
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« Reply #38 on: October 11, 2018, 06:58:24 AM »

Model Number 102R
Event Date 05/01/2012
Event Type  Injury   
Event Description
Analysis of the generator has been completed. The generator performed to specifications and no anomalies were found.
 
Event Description
It was reported on (b)(6) 2012, that a vns patient would be referred for generator revision surgery as the patient is at high settings, rapid cycling, and the patient' s family wanted to have it replaced prior to a trip they were taking in (b)(6). On (b)(6) 2012, clinic notes were received dated (b)(6) 2012 where it stated that the patient was diagnosed with complex partial seizures. The last seizure occurred on (b)(6) 2012 and was said to be less than 1 minute in duration. The patient's parents stated that the seizure have increased in frequency and duration over the last few weeks despite the patient being compliant with medications. The patient will intermittently appear blue or cold. The device was found to be set to 2. 5/20/250/21/1. 1/2. 75/250/60. The patient's dosage of sabril was increased from 2 tablets to 3 tablets and the patient was referred for generator revision surgery. Good faith attempts to obtain additional information have been unsuccessful to date however it is known that the patient is scheduled for generator revision surgery later next month ((b)(6) 2012).
 
Manufacturer Narrative
 
Event Description
Additional information was received indicating the patient's generator had been replaced. The explanted generator was returned and is currently undergoing analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2619580
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dennis100
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« Reply #39 on: October 19, 2018, 11:50:46 AM »

Model Number 102R
Event Date 08/02/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes were received for review prior to a patient going for a prophylactic generator replacement. Clinic notes dated (b)(6) 2012 were received. Reported was that she has unknown seizure frequency, but overall her parents think that they get the sense that her seizures are unchanged or possibly worsened since she was last seen in the clinic. She had increased output on the vns when she was last seen (b)(6) two weeks ago, she had some event reported to the family from the nursing home staff, which were concerning for apneic spells. Were told by the nursing home staff that she suddenly appeared to be "out of it"; and would slump over as if she were unresponsive or asleep. At the time she appeared to be turning bluish, and this resolved. She seemed to arouse when she was laid down flat. It was felt that these were not likely epileptiform events. She has a history of apneic spells in the past and does have obstructive sleep apnea per her parents reports. These event have not recurred since that time and she otherwise has been stable. The patient's vimpat was increased and her parents feel like her seizures may be worsening on this. Good faith attempts have been made and thus far no further information has been attained.
 
Event Description
Product analysis was completed on the explanted generator. 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. No further information has been received in regards to the patient's reported events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2745363
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dennis100
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« Reply #40 on: January 04, 2019, 11:37:30 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/23/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient experienced stridor and cyanosis while using their vns therapy magnet during a 56 minute long episode of continuous seizure activity. After the use of the magnet the patient continued to turn blue every five minutes for the duration of the seizure activity. A second magnet swipe during the seizure also produced temporary cyanosis. It was reported that while the patient typically had stridor/shortness of breath during seizures prior to vns implantation, that the stridor was more noticeable during the magnet swipes. Prior to and following this event, there were no other instances of cyanosis occurring with seizures. The patient had previously encountered minor stridor and shortness of breath events with magnet use during seizures but without complication. The physician decreased the patient's programmed generator settings. It was additionally reported by the patient's caregiver that when the magnet was placed over the device, to inhibit stimulation, the patient's symptoms seemed to resolve. It was reported that the patient's continuous seizure activity was not related to vns. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8175737
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dennis100
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« Reply #41 on: February 11, 2019, 02:44:07 AM »

Model Number 103
Event Date 01/06/2015
Event Type  Injury   
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.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4483657
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dennis100
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« Reply #42 on: April 06, 2019, 02:47:06 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/05/2019
Event Type  Injury   
Event Description
The patient¿s mother initially reported that the patient¿s oxygen saturation level was 83 (percent) and the patient¿s heart rate was elevated to 130bpm. The patient¿s breathing was a little rapid and her fingers were semi-purple. Additionally, the patient¿s body temperature was 100. 8 f. Information was later received that the patient was treated for these symptoms at the er and these events were referred to as ¿respiratory infection¿ symptoms. The patient was reportedly feeling better after treatment but it was unknown if the patient was discharged. The patient¿s device was left off per the neurologist¿s request. After the implant surgery and lead impedance was normal at 1955 ohms. A review of device history records for the generator and lead shows that no unresolved non-conformances were found. The device met all specifications for release and were verified to have been sterilized prior to distribution. Follow up with the patient's neurologist determined that the er physician and neurologist assessed that the patient had pneumonia which was not believed to be related to vns therapy or surgery. Additionally, the increased heart rate, fever, and discoloration of skin were assessed to be symptoms of the pneumonia and were unrelated to vns as well. There was no mention of the rapid breathing or hypoxia. The neurologist reported that the most recent update regarding the patient was that she was doing much better. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8465064
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« Reply #43 on: May 03, 2019, 03:26:39 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/24/2007
Event Type  Death   
Event Description
It was found through an obituary search that the patient had passed away. A battery life calculation was reviewed and showed the device was working as intended as the dcdc value was within normal limits. No anomalies were observed. Additionally, the battery life calculation estimation showed approximately 9. 4 years were remaining at the time of the patient's death; therefore, the device was likely still functioning. It was later reported by the patient's last known physician that he saw the patient the spring prior to her death. He stated he believed the death was not related to vns; however, since he did not see her at the time of her death, he could not be certain. Additionally he noted the patient also had lung issues (unrelated to vns) and rhett's syndrome.
 
Event Description
A death certificate was later received showing the patient died of leukopenia, anemia, and thrombocytopenia. The death was noted to be natural.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6438083
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dennis100
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« Reply #44 on: May 03, 2019, 03:27:16 AM »

Model Number 102R
Event Date 02/01/2015
Event Type  Injury   
Event Description
It was reported that a vns patient had vagal episodes from (b)(6) 2015 and persisted for 6 months. The device parameters were not changed. It was reported that during that period, the patient was in a clinic study (trial) from (b)(6) 2015. But due to high discomfort, she stopped it in (b)(6) 2015. It was reported that those discomforts included especially dizziness with nausea, sometimes accompanied by blurred vision and pallor, without loss of consciousness. It was reported that when a cardiologist saw the patient in (b)(6) 2015 for a clinic examination / ecg / abpm, the patient showed a sudden hypotension (70-80 systolic) without symptoms reported above. The patient was again seen by the cardiologist in (b)(6) 2015, who indicated that everything was fine. It was reported that the patient was initially implanted with vns in 2002, and then replaced in 2010. No patient adverse events were reported during that period before (b)(6) 2015. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5245961
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dennis100
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« Reply #45 on: May 03, 2019, 03:27:59 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 #46 on: May 03, 2019, 03:29:23 AM »

Model Number 103
Event Date 02/09/2010
Event Type  Injury   
Event Description
It was reported by the vns pt's mother, that the vns pt, who was implanted with the device on (b) (6) 2010, had experienced a syncope event, was very pale, not stable on his legs, and appeared lethargic. The device had not been programmed on at the time of the report of the events. Follow up with the treating physician revealed that the relationship of the syncope event to surgery/vns is unk, however, it was noted that the pt does not have a pre-existing history of syncope events. Additionally, it was noted that the pt "has autism and every change in his life is very difficult for him" and that the pallor, a lethargy were "probably not related to vns". No interventions have been taken for the events, the device has been programmed on, and the physician is in the process of titrating the settings up to therapeutic settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1631437
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« Reply #47 on: May 07, 2019, 07:34:58 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/15/2017
Event Type  Malfunction   
Event Description
It was reported by the physician's office that the patient's generator had migrated and the edge was pushing against the skin causing a breakdown of tissue. Clinic notes were received showing the patient was referred for an urgent evaluation of an extruding generator. It was also noted the patient had been experiencing some discomfort at the generator site and that the generator had seemed to migrate towards the axilla and recently developed a bluish discoloration with thinning of the skin, but without discharge. The patient denied fever, chills, or any change in status and the generator was still functional. Subcutaneous fluid collection and swelling were also noted at the generator site. The patient was referred for explant of the generator and the lead. It was later reported by the physician that the patient did not have an infection as the culture had come back as negative.
 
Manufacturer Narrative
Describe event or problem; corrected data: this information was inadvertently left off of the initial mfr. Report. If explanted, give date; corrected data: this information was inadvertently left off of the initial mfr. Report.
 
Event Description
The patient underwent vns explant on (b)(6) 2017. The physician did not know the cause of the migration.
 
Event Description
It was reported that the patient was experiencing an increase in seizures that began prior to the explantation of the vns. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6398375
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« Reply #48 on: May 11, 2019, 03:33:20 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/29/2019
Event Type  Injury   
Event Description
It was reported by the patient that he had a bad coughing fit after using his magnet and turned blue until he caught his breath. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8546726
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« Reply #49 on: July 05, 2019, 11:44:20 PM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/24/2003
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that the patient believes they had better seizure control was pre-vns therapy and post-vns therapy. It was also reported that the patient's finger tips and lips turn blue with longer seizures, and that the vns therapy magnet was never effective for the patient. Attempts have been made for information, and no additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8664897
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