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dennis100
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« on: January 04, 2016, 06:52:56 AM »

Event Date 01/24/2008
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that the pt was experiencing aspiration during recovery from vns implant. Follow-up with the physician indicated that aspiration was likely related to the pt recovering from the surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1004531
« Last Edit: January 29, 2016, 05:05:59 AM by dennis100 » Logged
dennis100
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« Reply #1 on: January 04, 2016, 06:53:24 AM »

Event Date 05/01/2002
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that patient experienced an episode of aspiration after implant surgery, but prior to initiating stimulation. Further follow-up revealed that the patient's device has since been programmed to on without incident. The patient is reportedly improving, but the event is not yet resolved. Physician indicated that the event was secondary to surgery and developmental delay and is not directly related to the ncp system.

Manufacturer Narrative
Further follow-up revealed that the patient's device was programmed to off because patient continued to have aspiration problems. The physician attempted to adjust the device parameters in order to alleviate the aspiration; however this was not successful. H. 6. : the ncp system labeling lists aspiration (fluid in the lungs) as a potential adverse event possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=406438
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dennis100
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« Reply #2 on: January 04, 2016, 06:53:55 AM »

Event Date 04/13/2005
Event Type Injury
Patient Outcome Disability; Required Intervention.
Event Description
Vns patient developed severe hoarseness four days post-implant. The patient has since been diagnosed with left vocal cord paralysis. Stimulation had not yet been initiated. The patient noticed some hoarseness the day after implant surgery which became worse over the next three days. Since that time, the hoarseness has neither worsened nor improved. At follow-up office visit, one treating physician indicated that the vocal cord paralysis was most likely related to the implant surgery and manipulation during the placement of the lead electrodes. The patient was prescribed decadron in an attempt to affect to swelling in the area. At follow-up visit with implanting surgeon, it was noted that the patient's hoarseness had progressed to aspiration of some liquids and fluids. The decadron reportedly provided no relief. Implanting surgeon indicated that the patient's symptoms are consistent with injury of a recurrent meningeal nerve. Implanting surgeon indicated that during implant surgery, the dissection was deep and with more retraction than is often required due to the patient's neck size and significant limitation and extension. It was reported that the patient has not been able to undergo any formal diagnostic direct or indirect laryngoscopy because they have had seizures during these attempted procedures. The patient is scheduled for a barium swallow and further follow up with an ent physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612665
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dennis100
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« Reply #3 on: January 04, 2016, 06:54:18 AM »

Event Date 04/26/2004
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that the pt has experienced worsening of aspiration since vns therapy system implant. Further follow-up revealed that the pt has not been feeling well since their third day post-implant and has been producing copious amounts of oral secretions and needs frequent suctioning. The pt's family member indicated that recent suctioning has been difficult because the pt has experienced bloody mucous due to irritation of their oral airway. The pt's family member later reported that the pt is doing better and is no longer requiring supplemental oxygen. The magnet has been taped over the device to temporarily discontinue device stimulation. The pt's family member also reported that prior to surgery, family member was aware of the increased risk of aspiration.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=530604
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dennis100
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« Reply #4 on: January 04, 2016, 06:54:39 AM »

Event Date 06/16/2000
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Vns pt with lennox-gastaut syndrome developed an infection immediately after implant due to excessive drooling and the infection worsened, extending into the pt's breast tissue. It was also reported that the pt began having problems with aspiration which led to aspiration pneumonia. The pt reportedly had to eat almost pureed foods during this time and was already very thin. The pt has since had surgery (type known) and no longer has the problem with aspiration. The pt's device has been programmed to off for over two years. Review of manufacturing records for the bipolar lead confirmed sterilization of the device and revealed no anomalies that would adversely effect device performance. Investigation to date has been unable to determine the cause of the aspiration pneumonia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=553342
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dennis100
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« Reply #5 on: January 04, 2016, 06:55:02 AM »

Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Rptr indicated that vns pt was being explanted due to aspiration. Investigation to date has been unable to determine a cause of the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=565697
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dennis100
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« Reply #6 on: January 04, 2016, 06:55:23 AM »

Event Date 10/13/2004
Event Type Injury
Patient Outcome Life Threatening;
Event Description
While in picu after initial implant surgery, the pt's oxygen level dropped from 98% to 71% and that a chest x-ray showed that they had aspirated. It was reported that the pt "let out a load yelp" when blood was drawn from the artery in their wrist, which cleared the blockage in their lung. The pt's breating reportedly started returning to normal afterward. The pt was also reportedly bleeding internally during this time, which was believed to be caused by toxic medication levels in combination with either a small scrape by the intubation tube or a posterior nosebleed due to the anesthesia. Investigation to date has been unable to determine the cause of the reported aspiration event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=585253
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dennis100
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« Reply #7 on: January 04, 2016, 06:55:47 AM »

Event Date 05/01/2005
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns pt aspirated and subsequently developed aspiration pneumonia. It was reported that the pt recently coded, requiring use of a defebrillator.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=610735
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dennis100
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« Reply #8 on: January 04, 2016, 06:56:11 AM »

Event Date 01/01/2005
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns pt underwent placement of a feeding tube because of excessive weight loss. It was reported that the pt "couldn't keep anything down". The surgery to place the feeding tube reportedly went well; however, the pt suffered a status seizures shortly afterward and subsequently aspirated. The pt then developed pneumonia in both lungs. Breathing treatments and antibiotic therapy were prescribed. The pt was not comatose, but was reportedly in an "altered level of consciousness" for unk reasons during this time. At this time, it is unk if the reported events are a result of the pt's disease progression or whether they are vns-related. Due to the length of time that the pt has been implanted with the vns therpay system, it is not likely that the events are vns-related. Report is incomplete because attempts to identify the pt's current treating neurologist have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=646478
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dennis100
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« Reply #9 on: January 04, 2016, 06:56:35 AM »

Event Date 05/01/2005
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Vns patient began coughing approximately one month ago and that the coughing increased to the point that the patient developed bronchitis and subsequent pneumonia. The pneumonia was treated with antibiotics, but eh antibiotics did not help. This lead to chronic aspiration and now the patient is on continuous oxygen due to low oxygen saturation. The patient's device was programmed to off in attempt to allefiate their symptoms. The patient has been instructed to follow-up with neurologist at his office in a couple of weeks.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=619815
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dennis100
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« Reply #10 on: January 04, 2016, 06:57:00 AM »

Event Date 08/19/2005
Event Type Injury
Patient Outcome Disability; Required Intervention
Event Description
Reporter indicated that vns pt implanted for treatment of depression was diagnosed by an ent with laryngeal palsy which is reportedly being treated with collagen. It was reported that the pt experienced hoarseness around the time of her first programming and was later seen by an ent due to aspiration and difficulty swallowing. Further follow-up revealed that the pt's hoarseness three weeks after a collagen injection into her vocal cords. The pt also indicated that she had some clear liquid aspiration per barium swallow performed one week post-implant, but that this had also improved. Report is incomplete because no response has been received to manufacturer's requests for additional information from treating psychiatrist (via fax x1). Additionally, device tracking information was not forwarded to manufacturer at the time of initial implant and this information was reportedly not contained in the implanting surgeon's records.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=642444
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dennis100
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« Reply #11 on: January 04, 2016, 06:57:23 AM »

Event Date 01/24/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported via clinic notes that a vns pt was having increase in seizures, voice hoarseness, and aspiration. On (b)(6) 2011, the neurologist referred the pt for generator replacement since it was near end of service. The generator was received by the mfr and currently is undergoing product analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2190784
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dennis100
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« Reply #12 on: January 04, 2016, 06:57:49 AM »

Event Date 05/03/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
On (b)(6) 2011, clinic notes from a vns treating physician were received through case management. Review of the clinic notes dated (b)(6) 2011 revealed that the patient was experiencing an increase in aspiration. The patient was programmed to output=1. 50ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=500usec. A battery life calculation was performed which showed negative years until eri = yes. Additional information has been requested from the physician but no further information has been received to date. When additional information is received, it will be reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2243281
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dennis100
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« Reply #13 on: January 04, 2016, 06:58:13 AM »

Model Number 302-20
Event Date 08/20/2012
Event Type Injury
Patient Outcome Other,Required Intervention
Event Description
It was reported by the patient's mother on (b)(6) 2012 that her son is in the hospital had it was confirmed that he had left vocal cord paralysis. The patient's mother reported that the patient has been in and out of the hospital for months now due to the problems with the vocal cords and aspiration pneumonia. She reported that the patient had been in and out of the hospital 10 times over the last year for aspiration pneumonia and the physician's finally today said it is left vocal cord paralysis. She states the neurologist turned patient's generator off on (b)(6) 2012. The patient had an aspiration study done the week prior and the patient's mother indicated that the aspiration was bad. The only thing that has changed is they increased one of his medications recently. No additional information is known at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2749205
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dennis100
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« Reply #14 on: January 04, 2016, 06:58:39 AM »

Model Number 103
Event Date 10/01/2014
Event Type Injury
Manufacturer Narrative
Event Description
It was reported that the patient had a mini stroke in (b)(6) and has since been experiencing aspiration and severe dysphagia. The speech pathologist did not know if the events were related to vns. She was planning to use muscle stimulation on the patient¿s throat. Good faith attempts for additional relevant information have been unsuccessful to date.

Event Description
It was reported that the patient was coughing up blood and having difficulty swallowing for approximately the past two months. The patient has changed physicians and when the patient was first seen by the new physician the patient was bradycardic and hypotensive. The patient's brother reported that the patient underwent testing because it was thought the patient had lunch cancer from spitting up blood. No additional relevant information has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377461
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dennis100
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« Reply #15 on: January 04, 2016, 06:59:07 AM »

Model Number 103
Event Date 10/01/2012
Event Type Injury
Event Description
The patient was not being seen for possible explant as reported on supplemental report #1. Patient had generator replacement as captured in mfg report #: 1644487-2013-03080.

Manufacturer Narrative
The supplemental report #1 inadvertently reported that the patient was being seen for explant. The patient was not being seen for explant.

Event Description
Clinic notes were received which indicate the patient experienced aspiration and vocal cord paralysis. Notes dated (b)(6) 2012 indicate the patient has a history of a breathing problem, for which the patient is seeing pulmonology. She also episodes of aspiration for which she is see an ear nose throat doctor. Neck ct scan taken on (b)(6) 2012 reported mild asymmetry of the vocal cord, likely due to the known vocal cord paralysis. Notes dated (b)(6) 2013 report that the patient's mother states the patient is going for a throat issue to fix her aspiration. Per the notes, the patient was going to have a surgical procedure to fix her vocal cord and her aspiration. The patient's vns device would likely get turned off for the surgery and be turned on again afterwards. Follow up with the physician found that aspiration is not related to the vns. The vocal cord paralysis has abated, but was diagnosed before the physician saw her. The vns diagnostics indicate the battery is at ifi = no.

Manufacturer Narrative

Event Description
Follow up with the physician found that the patient was diagnosed with the issue prior to seeing this physician and therefore no other information is available. The patient was being seen for possible explant. Surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3397096
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dennis100
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« Reply #16 on: January 04, 2016, 06:59:38 AM »

Model Number 105
Device Problem No Information
Event Date 07/18/2013
Event Type Malfunction
Event Description
Additional information was received that the surgeon did a procedure to treat the vocal cord paralysis and not the patient is experiencing an increase in seizures. At this time the surgeon does not know the cause of the increase in seizures. No other information was provided.

Event Description
The patient was to follow-up with orl surgeon. Upon further follow-up with regards to the seizures, the physician did not think the seizures have increased. The patient¿s seizures are noted to be occasional.

Event Description
Clinic notes dated (b)(6) 2015 reported in the history of present illness that since the vns has been placed, the patient has developed some vocal cord problems and was seeing an ent. No vns programming changes were made.

Manufacturer Narrative

Manufacturer Narrative
The supplemental report #3 inadvertently did not report this information from the physician.

Event Description
The physician indicated that the decreased motility of the vocal cord is probably related to vns therapy. The physician was unsure if the decreased motility of the vocal cord occurred with stimulation. The physician reported that the pneumonia has resolved and that the vocal cord paralysis is presumed to persist as her dysphonia has persisted.

Event Description
On (b)(6) 2013, it was reported that since the patient's vns revision surgery, the patient's voice has gone out. There were no further details on what this meant besides that the patient's voice got hoarse and the patient lost her voice temporarily. It was unknown whether this was with stimulation or not. The patient also had pneumonia after the surgery; however, the relationship to vns was unknown. Additional information was received that testing found the patient had some "sleepiness" of the left vocal cord. Per the physician, the pneumonia was likely related to the vocal cord not working as it probably allowed the patient to aspirate, causing the pneumonia. On the one month post-op visit, the physician noted that the wounds had healed nicely at that time. The patient was quite hoarse after surgery. Examination of the vocal cords indicated decreased mobility of the left vocal cord. It was noted that the vocal cord was not paralyzed, but had decreased mobility. The patient was experiencing mild aspiration. The physician gave the patient swallowing tips and recommended potential further action if the event did not improve; however, he was hopeful for resolution as there was some mobility. No additional information has been provided.

Manufacturer Narrative
Adverse event or product problem, corrected data: the supplemental report #1 inadvertently did not change the reportability to product problem since the patient is experiencing an increase in seizures with no reported interventions taken to date. Type of reportable event, corrected data: the supplemental report #1 inadvertently did not change the reportability to product problem since the patient is experiencing an increase in seizures with no reported interventions taken to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3322853
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dennis100
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« Reply #17 on: January 04, 2016, 07:00:05 AM »

Model Number 105
Event Date 06/26/2013
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2013 information was received from the reporter stating that the vns patient was aspirating liquids along with experiencing hoarseness since implant. It was reported that the patient was recently implanted and that the device had not yet been programmed on. It was reported that no device diagnostic tests have been performed since the device is off. The patient has been referred to neurosurgeon for follow-up. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3257441
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dennis100
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« Reply #18 on: January 04, 2016, 07:00:35 AM »

Model Number 102
Event Date 03/15/2013
Event Type Injury
Manufacturer Narrative

Manufacturer Narrative
Date of event: new information identified when the events started.

Event Description
It was reported that the events resolved on (b)(6) 2013.

Event Description
It was reported that a vns patient since being implanted (b)(6) 2013 presented with drowsiness, with nausea, vomiting, anorexia, aspiration when feeding from the implant. No rhythmicity depending on the frequency of stimulation. The patient therapy has been titrated per their study protocol. The patient had persistence of their symptoms the parents contacted the surgeon, who offered to temporarily stop their therapy to see if there would be improvement and check relationship to their device. Symptoms partially regressed between (b)(6). They disabled their device on (b)(6), and started again with modified settings (b)(6) the 2013. In the meantime, no change in symptoms. Their following physician does not think that the symptoms are related to the stimulation, provided that the patient has since developed a cold sore and fever. Only food-initial aspirations are potentially linked, in their opinion. No change in medication was reported and no medicinal treatments.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3132031
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dennis100
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« Reply #19 on: January 04, 2016, 07:01:02 AM »

Model Number 102
Event Date 07/12/2007
Event Type Injury
Event Description
On (b)(6) 2013, the patient's mother reported that the patient had the feeding port removed and "everything" was working functionally. The mother indicated that the patient's device was turned off, the patient's symptoms started to go away, and the patient has improved. Additional attempts were made to the physician for information; however, they were unsuccessful. No additional information has been provided.

Event Description
The patient's mother reported that the patient was doing well. No adverse events were reported. The patient was in the hospital on (b)(6) 2013, but no other information was provided.

Event Description
On (b)(6) 2013 the patient¿s mother reported that since (b)(6) 2013, the patient has had to have his feeding port replaced at the hospital 5 times as he rips them out immediately after having them put in. The patient no longer has a feeding port and is now eating only soft foods and will be having a swallow test.

Event Description
It was reported that the patient's vns was programmed off on (b)(6) 2012. The physician reported that the patient's pulsating neck and voice alteration first occurred in 2006 and that the difficulty swallowing and choking, aspiration, and loss of consciousness began in (b)(6) 2011. It was reported that the patient went into shock and his heart stopped which was a reaction to tp nutrition and not related to vns therapy. It was reported that the loss of consciousness was unrelated to vns therapy and that the loss of motility of the patient's esophagus was unlikely related to vns therapy. The physician reported that the patient's pulsating neck, voice alteration, difficulty swallowing and choking, and aspiration are possibly related to vns therapy. The patient's mother reports that the patient's gi motility has returned to normal. The patient has no history of these events prior to vns therapy.

Event Description
On (b)(6) 2013, the patient¿s mother reported that the vns has caused him to lose the ability of his vagal nerve and also caused his stomach to stop working properly. The patient had to have a feeding port put in. The mother stated that the infrared actually ¿revved up¿ his vns.

Manufacturer Narrative

Event Description
On (b)(6) 2013 when it was reported that the infrared on the wii almost burned out her son¿s vagal nerve and he has lost the ability to use his esophagus and had to have a feeding port put in. The reporter indicated that her son¿s problems began when they got a wii video game system about six years ago. She said that the infrared (ir) on the wii system revved up the vns to the point that it affected his voice and said you could see his neck pulsating. She said this happened every time her son was in the direct path of ir remote or receiver. She says that she did her own test using a board and a pillow - and she used this to block the ir signal. With the board and pillow blocking the ir signal, the patient was fine, but as soon as it was removed, the patient started exhibiting these adverse effects again (voice alteration and pulsating neck). She said that things started to get worse for her son, and in 2011, her son lost the ability to use his esophagus. She said she observed problems with choking and swallowing. She said she became very concerned about this when the patient started choking and aspirating and became unconscious. She says that an ambulance was called, and the patient was taken to the hospital. She said the physician at the hospital did an endoscopy and another test and found out that the patient lost motility of his esophagus and had problems with his stomach emptying. It was also said that the patient had ileus (bowel obstruction). The patient had to get a feeding port put in and during the implantation of the port, whatever they were giving him caused him to go into shock, and his heart stopped. She said the patient "came back" before they had to use the paddles to revive him. The reporter indicated that all these problems and complications boiled down to the vns device, so she had requested that the device be turned off. She said that she asked the physicians at the hospital to turn it off, which she thought they did, but it turns out they didn¿t. Their normal neurologist interrogated the device and saw it was still programmed on; therefore, the neurologist programmed the device off about 6 months ago. The reporter stated that after the device was disabled, the patient has been doing fine, and is even getting some motility in his esophagus back. Good faith attempts for further information from the neurologist have been unsuccessful. It was previously reported in (b)(6) 2011 that the patient was having problems with regurgitation and choking. The problem begins 3-4 hours after the patient is done eating and started a couple of months ago.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3127809
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« Reply #20 on: January 04, 2016, 07:01:28 AM »

Model Number 101
Event Date 05/18/2001
Event Type Injury
Event Description
Clinic notes were received for review. It was reported that this patient's device was at end of battery life. Clinic notes dated (b)(6) 2013: "he had a vagus nerve stimulator placed in 2003 or so and developed an upper gi bleed from recurrent retching. Endoscopy has revealed a hiatal hernia. " the relationship of this to their implant is unknown good faith attempts are underway for further details. The patient's father called and reported that the patient aspirated on (b)(6) and was in the icu, intubated, and discharged on (b)(6). The patient has left side weakness as a result of previous epilepsy surgery. The patient's father is an ent physician from another country, and states the aspiration was not caused by their vns but the patient's other co-morbidities. He reported that the patient was unable to tolerate increases in vns dosing over the years, causes "retching", since vns was placed in 2001. He does not believe that patient has received "much benefit" but feels that should have replacement as there are no other options left to him.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3075317
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« Reply #21 on: January 04, 2016, 07:02:11 AM »

Event Date 07/09/2007
Event Type Death
Patient Outcome Death;
Event Description
It was reported to the mfr that a vns epilepsy pt had passed away. The pt is believed to have died as a result of aspiration of vomitus following a seizure. Attempts to obtain add'l info from the treating physician regarding the event have been made, but have been unsuccessful to date. The last diagnostics tests performed on the pts' device indicate the device was functioning as intended.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=902609
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« Reply #22 on: January 04, 2016, 07:02:33 AM »

Event Date 02/08/2008
Event Type Death
Patient Outcome Death;
Event Description
It was reported to manufacturer that the vns patient passed away. The site reported that the patient had aspirated and was taken to the emergency room with decreased oxygen. The patient coded in the emergency room and was subsequently placed on a ventilator. The patient reportedly expired due to aspiration and respiratory distress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1012528
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dennis100
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« Reply #23 on: January 04, 2016, 07:02:59 AM »

Event Date 06/22/2002
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that pt passed away due to aspiration. The pt reportedly aspirated in their sleep and was found dead in the morning. The pt was last seen by the physician in 05/02 and was receiving vns therapy at the time of death. No autopsy was performed and the ncp system was not explanted. The pt reportedly had a >50% reduction in seizures with the ncp system.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=421687
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dennis100
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« Reply #24 on: January 04, 2016, 07:03:21 AM »

Event Date 01/05/2003
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. The death certificate listed the cause of death as complication of chronic aspiration, cerebral palsy and microcephaly. Premature birth was listed as another significant condition contributing to death but not resulting in the underlying cause. The manner of death was listed as natural. Physician indicated that the ncp system was not related to the cause of death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=441705
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« Reply #25 on: January 04, 2016, 07:03:44 AM »

Event Date 10/09/2002
Event Type Death
Patient Outcome Death;
Event Description
Mfr periodically compares device tracking info to the social security death index for the purpose of updating device tracking data. Mfr became aware of pt death during this process and evalauted available info against current procedures. The event did not meet mdr reporting criteria per manufacturer's current procedures. In an effort to obtain additional info regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by mfr. Death certificate lists immediate cause of death as respiratory insufficiency secondary to pulmonary congestion and edema with aspiration and probable seizure. Autopsy results were considered in determining the cause of death. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the patient's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=507048
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« Reply #26 on: January 04, 2016, 07:04:12 AM »

Event Date 01/06/2005
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that vns pt had passed away. It was reported that the pt had several seizures, aspirated and then had a heart attack. No autopsy was performed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. There is no evidence at this time that the vns therapy system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=571493
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« Reply #27 on: January 04, 2016, 07:04:34 AM »

Event Date 08/05/2000
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Field report: pt implanted with the vns on 2000. No complications during surgery. However, surgery did take a bit longer than usual due to aberrant anatomy. Post-operatively the pt aspirated. The pt was kept at the hosp overnight for observation and released the following day. The device was not turned on. The facility's medical director concluded the death was related to seizures. Pt death f/u form: physician reports believed relationship between the ncp system and cause of death to be not related. Found unresponsive, resuscitation efforts unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=317944
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« Reply #28 on: January 04, 2016, 07:04:58 AM »

Event Date 09/11/2005
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that vns pt had passed away. It was reported that the pt experienced 2 bad seizures and was subsequently hospitalized approx 1 1/2 weeks post vns implant surgery. Stimulation had not yet been initiated. The pt aspirated while hospitalized and later passed away while hospitalized. The pt was diagnosed with ards (acute respiratory distress syndrome). Treating neurologist indicated that cause of death was aspiration pneumonia secondary to seizure and ards. The device was not explanted prior to burial. Certificate of death lists acute respiratory failure, secondary to acute respiratory distress syndrome, secondary to aspiration pneumonia-bilateral as the cause of death. No autopsy was performed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=642198
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« Reply #29 on: January 04, 2016, 07:05:25 AM »

Event Date 04/09/2011
Event Type Death
Patient Outcome Death;
Event Description
It was reported that the pt had passed away. Per reporter, the pt was hospitalized due to him being in status epilepticus. The hospital then put him in an induced coma to try to control them. While in the induced coma, the pt then aspirated and died. The physician indicated that the status epilepticus was not related to the vns. Attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2116606
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« Reply #30 on: January 04, 2016, 07:05:48 AM »

Model Number 104
Event Date 12/14/2012
Event Type Death
Event Description
It was reported that the vns patient passed away on (b)(6) 2012. The cause of death is believed to be due to aspiration. The relationship between the death and vns is unknown. No further information relevant to the patient¿s death has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4163522
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« Reply #31 on: January 04, 2016, 07:06:13 AM »

Model Number 102
Event Date 05/22/2010
Event Type Death
Event Description
It was reported that the treating vns physician's office had not seen the patient since 2010 and had not future appointment. Upon review of the internet, the patient's obituary was found which reported the patient passed on (b)(6) 2010. Review of the company programming history database shows that the treating physician programmed the patient's device on (b)(6) 2010 and increased the output current at that time. Attempts for additional information from the physician have been unsuccessful to date. Follow-up with the funeral home revealed that it is not believed that the vns devices were explanted prior to burial.

Manufacturer Narrative

Event Description
It was reported that the cause of death was due to a subclavian clot and that the patient experienced a swallowing disorder and seizures. The hospital medical records indicated that the patient was hospitalized prior to the patient's death from (b)(6) 2010 and was diagnosed with dvts in the upper arms, respiratory distress, seizure disorder, dyspnea, altered mental status, gastro-esophageal reflux disorder and paranoid schizophrenia. It was reported that the patient was in hospice care at the time of his death, but that there are no records in the medical records office from that time. It was reported that the patient was buried and was most probably buried with the vns still implanted. It was reported that the vns helped the patient's seizures. Additional hospital notes were received from the hospitalization prior to death indicating that the patient was observed to have stopped breathing and was pronounced death on (b)(6) 2010. It was noted that the overall clinical impression was that the patient had respiratory failure and lactic acidosis secondary to recurrent aspiration pneumonia. The death certificate listed seizure disorder as the cause of death due to (or as a consequence of) swallowing disorder with aspiration, due to (or as a consequence of) subclavian vein thrombosis. The manner of death was listed as natural. No autopsy was performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3232880
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« Reply #32 on: January 05, 2016, 12:48:18 AM »

Model Number 102R
Event Date 03/07/2013
Event Type Death
Manufacturer Narrative

Event Description
It was reported that a vns patient passed away on (b)(6) 2013. Their death was not related to their vns device but sudep is suspected to be the cause of their death. The pt weighed (b)(6), the etiology of their seizures: iatrogenic hypoglycemia secondary to insulin in the nursery. The patient had quadriparesis, cortical blindness dysphagia and gerd. The patient had seizure reduction with the vns. They were receiving vns therapy treatment at the time of death. They were set to 2. 00 ma,20 sf ,250 pw ,7 seconds on time,30 seconds off time ,2. 25 ma ,60 seconds on time ,250 pw. No products were explanted at the time of death. No autopsy performed, their death was not witnessed. The patient was found pulseless in the am, cold, lying in bed and no signs of a struggle. The patient did have a history of nocturnal seizures. The patient does have a history of mild aspiration with no recent pneumonia at time of death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3035470
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« Reply #33 on: January 14, 2016, 09:53:22 AM »

Model Number 102
Event Date 02/01/2011
Event Type Injury
Event Description
On (b)(6) 2013, the physician reported that the patient's increased seizures, aspiration, and sepsis are not related to vns. The patient has a long history of health problems prior to vns. This was the only information the physician was willing to provide.

Event Description
On (b)(6) 2012, clinic notes were received dated (b)(6) 2012, which indicated that the patient's last bad seizures were in (b)(6) 2011, when the patient aspirated and stayed in the hospital for 77 days. It was noted that the patient has bad breakthrough status due to sepsis. The relationship of these events to vns was not provided in the clinic notes. Attempts for further information from the physician are underway but no additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2870434
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« Reply #34 on: January 15, 2016, 11:08:15 AM »

Model Number 103
Event Date 01/04/2014
Event Type Death
Event Description
It was reported that the vns patient passed away on (b)(6) 2014 due to respiratory arrest from aspiration of food following a long seizure. Attempts for additional relevant information were made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3738587
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« Reply #35 on: January 17, 2016, 05:49:51 AM »

Model Number 303-30
Event Date 11/01/2012
Event Type Injury
Event Description
Additional information was received when the two 3. 0mm leads that the surgeon had tried to implant in the patient were returned to the manufacturer for product analysis. Product analysis is still underway and has not yet been completed.

Manufacturer Narrative
Brand name; corrected data: inadvertently listed "lead model unknown" instead of "lead model 303" on initial report.

Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient was scheduled for an ent evaluation. It was reported that the patient has left vocal cord weakness. Clinic notes dated (b)(6) 2013 were received which indicate that the patient has multiple medical problems including chf, dm, htn, copd, and cva ((b)(6) 2012) who presents to the neurosurgery clinic to be assessed for placement of a vagal nerve stimulator. The patient reported that over the past year, his seizures have progressed in frequency and severity with him now having multiple daily grand mal seizures; when his seizures first occurred, he notes he had one seizure per year. In (b)(6), the patient reports that the surgeon attempted to place a vns on two separate occasions but failed. The patient reports that his vagus nerve was too large which lead to the vns leads breaking each time. The patient has had dense hoarseness since the procedures. Due to the cross reactions between his aeds and cardiac medications, as well as the progressive nature of his seizures, the patient has been urged by his neurologist and cardiologist to have a vns placement attempted once more. Additional clinic notes were received from a visit with another surgeon who indicated that the patient has history of an mri showing evidence of a stroke involving a right artery. The patient is having progressively worsening frequency and severity of seizures refractory to current medications and has 2 failed vns placement attempts. It was stated that an assessment of the patient's vocal cords with an ent is needed as the nerve may be transected or permanently damaged. The patient was seen by an ent specialist on (b)(6) 2013 for evaluation of hoarseness and dysphagia. The patient's quality of voice was raspy and rough and the severity was moderate with a significant impact on voice quality or function. The hoarseness started 11/1/2012 after vns surgery. Associated manifestations are dysphagia, frequent heartburn, sore throat, and tobacco use. The patient feels like foods and liquids don't go down and get stuck, also chokes and coughs at times - all new since surgery. The dysphagia is in the lower throat and the patient feels like food sticks in the throat, has a "lump in throat sensation" and states that even swallowing air can give him a choking sensation. The event is moderately severe. Aggravating factors include swallowing liquids, swallowing saliva only, and swallowing solid food. Associated manifestations include frequent heartburn or indigestion, frequent or chronic hoarseness, frequent or chronic sore throat, neurological problems, and pressure sensation in throat. It was found that there was mobility reduced motion in left cord. The right vocal cord had normal mobility but the left vocal cord was limited. There was good approximation of vocal cord phonation but paresis of left vocal cord was suspected. The patient was referred for a barium swallow to evaluate swallowing issues. The operative notes from the (b)(6) 2012 surgery stated that the vagus nerve was exceptionally large comparative to average anatomy. The 2 mm lead was coiled around the nerve and after coiling it was noticed that the vagus nerve due to the extensive size was being strangulated by the lead placement. Due to the large diameter of the vagus nerve it was felt that the coil could not be kept in contact with the nerve without jeopardizing safety. At that point the procedure was aborted with the incision was copiously irrigated with antibiotic solution. The patient was noted to be morbidly obese. On (b)(6) 2013 it reported that the patient has been going to speech therapy and his voice is improving. The patient started speech therapy about 2 weeks prior and is seen 2 times per week for 2 hours. The patient underwent a modified barium swallow on (b)(6) 2013 and the notes from this visit indicate that the diagnosis was dysphagia and that the patient had left vocal cord weakness. The patient was noted to have a history of coronary heart disease, cva, diabetes, chronic back pain, obesity, and hypertension. The patient had resilient (l) side weakness from cva, gerd. The patient had decreased voice and reports coughing on liquids. Gerd was not observed during evaluation. The patient had aspiration throughout assessment. Oral and pharyneal phases of swallowing are normal. No aspiration with modified barium swallow under fluoroscopy.

Event Description
On (b)(6) 2012 it was reported that the patient was to have an initial implant that day, but the hospital only had 2 mm leads in stock and upon opening up the patient, it was found that he has a big vagus nerve. The surgeon attempted to implant the 2 mm lead but it was constricting the patient's nerve so it was removed and the patient was closed up. The patient was asked to stayed overnight at the hospital to have surgery the next day with a 3 mm lead that was being shipped to the hospital. The patient's wife did not want the patient to stay overnight and wasn't sure she wanted to risk him going through another surgery if the new lead does not fit. On (b)(6) 2012, it was reported that the patient underwent surgery again with a 3 mm lead. The surgeon noted that the vagus nerve was swollen from the previous surgery and due to the patient having a very large neck he was not able to get good enough exposure of the nerve to get the electrodes around the nerve. The patient was closed up again and sent home. The surgeon also noted that the two 3 mm leads he tried to use lost their coil form after trying to coil nerve.

Manufacturer Narrative

Event Description
Additional information was received on (b)(6), 2012 when product analysis was completed on the returned leads. The condition of the returned leads was consistent with conditions that typically exist following manipulation of the leads. The patient stated that his voice is still raspy; he has to yell to be heard. The patient also mentioned that if he has a coughing fit, or laughs in a certain position, he feels like he is being chocked. The surgeon stated that he thinks the patient is too large and the leads will not fit. Although implant surgery is likely, it has not occurred to date.

Event Description
Additional information was received on (b)(6) 2013, when it was reported that a second surgeon told the patient he needed to see an ent (ear, nose, and throat) physician because the nerve might have been severed in the previous surgical attempt. The patient later reported that the second surgeon wants a veeg, ent evaluation, and or notes from the initial surgeon. The patient stated that he is still raspy, struggles to push out air and to be heard, when he touches the skin on the left side of neck to throat area, it feels numb. He also stated that if he laughs real hard or gets excited, he starts choking and may gag while drinking fluid, even on air. The patient stated that he has a history of choking on meat, but he thinks that is because he has no teeth.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2845744
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« Reply #36 on: January 20, 2016, 11:11:35 AM »

Model Number 103
Event Date 10/10/2012
Event Type Injury
Event Description
On (b)(6) 2012, it was reported that the vns patient had a vns replacement surgery on (b)(6) 2012 and the last diagnostics on (b)(6) 2012, were all fine with an impedance value of 2000 ohms and the patient was increased form an output of 1. 25ma to 1. 5ma. Previously in (b)(6) 2012, the patient was at output=1. 25ma/pulse width=250usec/frequency=20hz and the pulse width was increased to 500usec and the frequency increased to 30hz. The patient was tolerating vns well. Currently the patient's settings are output=1. 5ma/pulse width=500usec/frequency=30hz/on time=30sec/off time=5min. On (b)(6) 2012, the patient underwent a routine feeding assessment by his speech and language therapist, who had seen him 4 months previously. The therapist felt that he was aspirating on liquids during the hour that she assessed him. This was constant, and not only during stimulation. The mother had not reported any concerns but the therapist says she definitely noticed a difference since his last assessment. She has referred him for investigation and modified his diet. The patient was seen again by the neurologist on (b)(6) 2012, where the nurse changed the parameters to output=1. 5ma/pulse width=250usec/frequency=25hz/on time=30sec/off time=5min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=500usec. Diagnostics showed the device to be functioning properly with output=ok/lead impedance=ok/impedance value=1986 ohms/neos=no. There has been no trauma or manipulation that might have caused the problem. The nurse reported that at this time they believe the aspiration is constant and there are no concerns noted on observation prior to interrogation or afterwards; patient was observed for an hour after. The patient's parents report that it has always been difficult to get the patient to drink water, the patient holds it in his mouth and it dribbles out and he sometimes coughs on it. The patient drinks milk without any similar concerns. No change in parameters and no subsequent improvement was observed. No other interventions are planned besides reducing the pulse width and signal frequency in case stimulation might have interfered with swallowing. The patient's parents do not think it is likely as there has been no ongoing problem with feeding noted by them.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2816573
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« Reply #37 on: January 21, 2016, 02:45:04 AM »

Model Number 102
Event Date 09/17/2012
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2012 were received on (b)(6) 2012. The notes indicated that the patient had pneumonia, pediatric and adult obstructive sleep apnea, aspiration pneumonia, and dysphagia causing pulmonary aspiration with swallowing. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2810272
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« Reply #38 on: January 21, 2016, 08:45:29 AM »

Model Number 103
Event Date 07/06/2012
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2012 were received on (b)(6) 2012. Notes dated (b)(6) 2012 indicated that this vns patient had a past medical history of (b)(6). The notes also indicated that the patient continued to have breakthrough seizures but that the seizure frequency was significantly improved since vns therapy. The patient had generalized tonic-clonic seizures, complex-partial seizures and frontal lobe seizures. On occasion, the patient needed diastat to treat severe seizure activity. Notes dated (b)(6) 2012 indicated that the patient had a seizure on (b)(6) 2012 for which he was taken to the emergency room. During transport the patient aspirated and stopped breathing. There was no provoking factor for the episode but may have been triggered by fluctuating serum levels of his antiepileptic drugs. During follow-up, the physician stated that he did not know if the (b)(6) was related to vns as the event occurred prior to the patient being in his care, and the patient medical history was filled out by the patient's sister. No additional information was available. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2806978
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« Reply #39 on: January 25, 2016, 01:17:32 PM »

Model Number 103
Event Date 02/01/2012
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2012, it was reported that this patient underwent surgery in (b)(6) 2012 for another procedure. When the patient was waking up from anesthesia, she began to aspirate. The physician believed the device was on during the procedure. The relation of the aspiration to vns and/or medication was unknown. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2773208
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« Reply #40 on: January 26, 2016, 03:26:50 AM »

Event Date 09/04/2012
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2012 a nurse reported that they are seeing increased chest infections in some patients. It was discussed that if stimulation was causing swallowing difficulties, than possibly aspiration could be occurring. This report and mfr. Report number 1644487-2012-02468 are addressing these patients. Additional information has been requested but no further information has been received to date.

Event Description
Additional information was received on (b)(6), 2012 when the patient's identity was provided for mfr. Report # 1644487-2012-02468. The nurse also reported that no further information could be obtained from their office, therefore the patient in this report and the relationship of the event to vns is still unknown.

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« Reply #41 on: January 29, 2016, 05:02:34 AM »

Model Number 102
Event Date 04/04/2009
Event Type Death
Event Description
It was reported that the patient passed away. The date of death was (b)(6) 2009. A sudep evaluation for this patient was performed and it was indicated that the death is possible sudep. Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative
Date of event: the patient passed away on (b)(6) 2009, however it was initially reported that the patient passed away on (b)(6) 2009.

Manufacturer Narrative

Event Description
Follow up was performed and it was indicated that the patient passed away from respiratory failure due to chronic aspiration. The cause of death was not believed to be related to vns. Attempts were made for product return; however the device was not explanted at the time of death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2669431
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« Reply #42 on: January 30, 2016, 02:24:15 AM »

Model Number 102
Event Date 06/17/2012
Event Type Injury
Event Description
It was reported by a company representative that a vns patient experienced voice alteration and aspiration due to unknown reason. The patient was referred to an ent and at the moment are pending results from evaluation. Moreover, information from the treating neurologist indicated the generator was off at the time of the events. The patient had little dysphonia which has disappeared. Corticosteroid therapy was started and the voice had almost normalized. Aspiration was found by ent physician and a reported swallowing difficulty was present pre-vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2656871
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« Reply #43 on: February 01, 2016, 05:53:12 AM »

Model Number 103
Event Date 04/10/2012
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2012, a physician's office reported that this vns patient was admitted to the hospital, had been in status epilepticus, and needed vns battery replacement. Clinic notes were received on (b)(6) 2012 for (b)(6) 2012 through (b)(6) 2012. These notes indicated increased seizure duration, increased seizure intensity, and increased seizure frequency. The notes also contained ''"date noted"''; for aspiration pneumonia ((b)(6) 2011), respiratory distress ((b)(6) 2011), respiratory syncytial virus pneumonia (rsv) ((b)(6) 2011), and chronic pulmonary aspiration ((b)(6) 2012). Notes dated (b)(6) 2012 state that the patient's mother reported that the patient occasionally has a few ''smaller'' seizures, but no big seizures. However, for the past three days (beginning (b)(6) 2012), the patient began crying with both arms flexed and stiff with bilateral fisting. These episodes last up to 30 minutes. The patient ceased crying when the mother was present, but began crying again when the mother left. The physician's impressions of the patient indicated that over the past one to two months there has been an increase in seizures again with eyes rolling, stiffening, and respiratory irregularities. The notes also reported that another physician reported that the patient has had several episodes of longer seizures for the past several weeks (approximately (b)(6) 2012). Notes dated (b)(6) 2012 state that the patient's device was interrogated for the first time since (b)(6) 2011. The patient's vns settings indicated that the device was disabled due to end of service. No stimulation was being provided as the normal mode and magnet mode output currents were found to be 0 ma. The device was programmed to a normal mode output current of 0. 25 ma (magnet mode 0. 50 ma), and it was stated that the patient is having increased seizures due to the vns battery dying. Consult for replacement surgery was recommended. Notes dated (b)(6) 2012 indicated that the patient had recurrent respiratory infections; however, at this time, there were no features of an active infection or aspiration. Notes dated (b)(6) 2012 stated that the patient's device was disabled due to it being problematic. Follow up with the physician's office on (b)(6) 2012 revealed that the statement regarding the generator being ""problematic""; was a reference to the generator at end of service. The physician's office stated that the patient's reported increase in seizure duration was an increase in the actual seizure time. They were unable to state the relationship of the increased seizure duration and increased seizure intensity to vns because medication changes and the loss of therapy due to end of service were simultaneous. No details were available regarding the increased seizure intensity: it was only stated that the patient's eeg was worse. No interventions have been planned. When asked about the respiratory difficulties, pneumonia, and aspiration, it was stated that this was the patient's baseline and that these issues remained unchanged with relation to vns. Vns replacement surgery is likely but has not taken place to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2594672
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« Reply #44 on: February 02, 2016, 07:01:41 AM »

Model Number 302-20
Event Date 03/01/2012
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Describe event or problem: corrected data. Omitted x-ray review on initial mdr report. Manufacturer reviewed x-rays of implanted device. X-ray review by the manufacture revealed a sharp angle near the connector pin.

Event Description
Additional information was received that the patient's explanted generator will not be returned for analysis as it went home and was not returned. Their electrode was left in place because the patient had established fibrosis and it would have been too risky for the patient to properly dissect around the vagus nerve. X-rays were reviewed. The generator is placed in a normal arrangement on the upper left chest. In the ap chest x-ray view taken after implant, the filter feed-through wires appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. The lead wires at the connector pin appeared to be intact. A strain relief bend and loop were present, but not as specified by the labeling. Tie-downs were used to hold the bend and the loop. Portions of the lead appeared to be behind the generator and could not be fully assessed. Neither lead breaks nor acute angles were observed in the assessed portions of the lead. In the ap chest x-ray view taken after the report of "lead pulling sensation", the generator appears in the same placement, but seems to have been turned in an anti-clockwise direction with respect to the first x-rays. The filter feed-through wires still appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. The lead wires at the connector pin were not intact and presented two sharp angles. The strain relief bend and loop were not present any more, and instead a sharp angle appeared right below the positive electrode, in the lead bifurcation.

Event Description
Additional information from the treating physician indicated the explanted material was provided to another medical professional for vigilance. At the moment attempts have been unsuccessful to date to obtain the explanted devices returned to the manufacturer for analysis.

Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not list type of report. Initial report should have had indicated 30-day report.

Event Description
It was initially reported by a company representative that a vns patient experienced an increase in seizures and the suspicion the patient's lead being detached from the nerve. The patient's device was reported to have been programmed off. Additional information was received from the treating physician indicating the increase in seizures began in (b)(6) 2012 and around (b)(6) 2012, there was a complaint of lead pulling sensation. No patient manipulation or trauma was suspected to have contributed to the event and the system diagnostics from implant were within normal limits. Nonetheless, the physician believed the increase in seizures (below pre-vns level) was related to hardware failure. Moreover, the treating physician indicated the patient had undergone generator and lead removal surgery as the patient presented aspiration and bi-tonal voice. The physician indicated the explanted electrode was twisted on itself and believed this caused the winding tension on the nerve. Some manipulation of the electrode was seen in the generator area as the lead was coiled. At the moment replacement surgery will be planned after the patient ameliorates on the reported aspiration and bi-tone voice.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2576889
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« Reply #45 on: February 08, 2016, 07:32:18 AM »

Model Number 106
Event Date 12/28/2015
Event Type Injury
Event Description
During initial vns implant, the patient aspirated while waking up from anesthesia. The patient developed a lung infection in the right lobe and was transferred to another hospital as the implanting hospital did not have a pediatric unit. It was later reported that the patient was discharged home with a feeding tube which was removed the following week. It was reported that the patient has now returned to his normal state.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5397100
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« Reply #46 on: March 04, 2016, 08:16:11 AM »

Model Number 103
Event Date 07/31/2012
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient passed away due to aspiration during a severe seizure on (b)(6) 2013. The vns was last checked on (b)(6) 2012 and system diagnostics checked good. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

Event Description
On (b)(6) 2013, the physician reported that he did not see how there could be a relationship between vns and the patient¿s death. He stated that he saw the patient recently at a marathon and again at the summer special olympics, and the patient seemed fine. The patient's father stated that the patient had a seizure during the olympics, however, the patient was walking up to him (the physician) within half an hour of this seizure. The physician stated that the patient did not experience any increase in seizures and that the death was not related to vns. The physician stated that the death was probable sudep as there was no underlying event for this, and the patient fit the criteria. He stated that he heard about the death a few weeks after he last saw the patient and that there were no extenuating circumstances that preceded the death, so the death was assumed to be sudep. The physician did not have the patient's programming or diagnostic history. No other information was provided. Follow-up with another physician confirmed that there was no relationship between vns and the patient¿s death except that the patient had refractory epilepsy. He said that the vns was working fine and that the patient's device had been interrogated shortly prior to the death and had normal results. Attempts for product return showed that the device buried with the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3197260
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« Reply #47 on: March 06, 2016, 04:01:45 AM »

Model Number 103
Event Date 07/13/2011
Event Type Injury
Event Description
Additional information was received on (b)(4) 2012, when it was reported that the patient's lead and generator were explanted and not replaced on (b)(6) 2012. Follow up with the site revealed that the device was removed due to lack of efficacy and they did not have any additional information to provide. The lead and generator were received by the manufacturer on (b)(4) 2012 and are currently undergoing product analysis.

Event Description
Additional information was received on (b)(4) 2012, when analysis of the explanted lead was completed. Note that since a portion of the lead (including) the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above typical wear and explant related observations, no anomalies were identified in the returned lead portion. The analysis of the generator was completed on (b)(4) 2012. Electrical test results showed that the pulse generator performed according to functional specifications. Visual inspection results revealed no external device abnormalities. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
On (b)(6) 2011, a vns treating nurse practitioner reported that the vns patient was in the hospital due to seizures. The patient's parent is concerned because when they tape the magnet over the device during meal time recently to halt voice alteration, the device still provides stimulation. In order to double check this report, the nurse practitioner taped the magnet over the device that day in the hospital for about 20 minutes and the device was still activating while the magnet was in place. System diagnostics and normal mode diagnostics were performed on the generator and results were normal; impedance value of 2621ohms and 2635ohms respectively. The device was interrogated and the magnet activations were examined. The handheld showed that the device recorded multiple magnet activations while the magnet was in place for about 20 minutes. The manufacturer's consultant reported that the magnet was taped securely to the skin and the generator is able to be visualized under the skin. The patient was implanted recently in (b)(6) 2011, so the magnet is fairly new. The nurse practitioner stated that she did not know if there was any trauma to the site. The generator is currently disabled due to the magnet issue and the most recent settings before it was disabled were output=1. 5ma/frequency=20hz/pulse width=250usec/on time=21sec/off time=3min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=250usec. The nurse practitioner reported later that the patient falls a lot but the parents don't know if he fell on the generator directly. His impedance checked out normally for both system and normal mode diagnostics. The patient's brother did bite him near the generator but did not break the skin. He aspirates during stimulation, so they now have the generator off. The patient has had aspiration pneumonia for a while now, so the magnet was being used to disable the device while eating. The nurse did not know if the patient has a history of aspiration, but did state that they have questioned whether or not the vns has made the aspiration worse. Lately (time frame unknown), the mother has noticed that the magnet is not working as it did to disable the device. The nurse states that the magnet had been helping at one point, though, and had improved the patient's aspiration. She stated that the patient has had worsening focal status and that the mother reports that the vns has not helped. The nurse stated that the generator protrudes from the chest so she is sure that the magnet is properly taped over the device. The patient's mother has tried both magnets that came with the patient kit but neither will work lately and it is unknown which side is being taped facing the generator. The nurse reported that she does not know where the magnets are stored when they are not in use. The nurse then stated that during the 20 minutes that the magnet was taped over the device, the patient experienced voice alteration 3 different times for about 60 seconds (magnet on time is 60 seconds). After the device was disabled, no voice alteration was observed. The physician's nurse reported that they tried new magnets and they also did not work to disable the device. Therefore, the patient's generator is programmed to 0ma at this time. The patient has progressively worsening epilepsy and they do not think that it is related in any way to vns. They did not think the vns was helping even before it malfunctioned. If additional information is received it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2200870
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« Reply #48 on: March 06, 2016, 11:03:20 AM »

Model Number 102
Event Date 07/04/2011
Event Type Injury
Event Description
It was reported by the patient's speech pathologist that the patient had "severe oral dysphagia"; the patient also reportedly coughed what she ate. The patient had been admitted to the hospital for aspiration pneumonia, confirmed with a barium test. The mother believed that some of the issues could coincide with a fall the patient experienced. The mother later indicated that the patient was "seriously ill. " the patient was admitted to the hospital for chest pains, which was later diagnosed as pneumonia with aspiration into the lungs. The patient's muscles in her throat had weakened. Consequently, when she swallows, the matter goes into the wrong pipe, causing aspiration into the lungs. The patient's mother stated she had searched and saw that the vns may be causing some of these issues. The patient may have a tube placed due to the issues she is having. Later information from the patient's speech pathologist indicated that the patient's swallowing problems were the same when the device was on and off. The therapist stated she could not state whether the device was causing the swallowing issues, just that the issues were not made worse with stimulation. The mother again told the manufacturer of her daughter's issues. She stated that she could not say the vns was the cause of the problem, but that it could be a cause. The patient recently was not able to stand, was lethargic, and her head was going to one side. Also, the patient was not able to find objects 6 inches in front of her. Additional information from the patient's parents showed that for the past two years, the patient had had problems with choking, aspiration, fainting, low blood pressure, and pneumonia. They had initially believed these issues were due to ongoing dental issues, but after research on vns, they had conducted on their own, the vns may cause these issues. The father of the patient stated the settings had been decreased by 0. 25 ma every month, but they were afraid to disable the vns. The patient's last known settings and diagnostics show proper device function. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2196460
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« Reply #49 on: March 09, 2016, 03:05:48 AM »

Model Number 102
Event Date 03/24/2014
Event Type  Death   
Event Description
Follow-up revealed that the patient died at the hospital due to acute respiratory failure suspected to be secondary to aspiration. The patient was admitted to the hospital with respiratory difficulties thought to be secondary to aspiration with pneumonia. The patient had a do not resuscitate and therefore was given morphine and made comfortable. The patient passed away shortly after being removed from bipap.
 
Manufacturer Narrative

Event Description
It was reported that the patient passed away. It was reported that the cause of death was not related to vns therapy. It was reported that the patient's device has been at end of service for approximately two years. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3765234
« Last Edit: January 11, 2019, 02:58:45 AM by dennis100 » Logged
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« Reply #50 on: March 12, 2016, 08:06:41 AM »

Event Date 01/30/2006
Event Type Injury
Event Description
Our (b)(4) office was contacted by the solicitors office in (b)(6) asking for some information in regards to a vns pt and a road traffic incident. It was reported that they had temporary paralysis of the left vocal cord. Her physician believed that the impact caused her seatbelt to press against her with force causing trauma to her vagal nerve and causing the vagal nerve stimulation device to be moved resulting in throat problems. Additional information was rec'd that the pt had their vns implanted 10 years ago and a generator replacement was done in 2005. The pt had no problems with her vns until she was in a road traffic accident on (b)(6) 2006 when their car was hit by another car. She was a passenger in the back seated in the middle and got severe impact from her safety belt. She developed lower lobe pneumonia in hospital. The day she had the accident she also started to suffer from micro aspiration, choking episodes, reflux, problems swallowing, sore throat, gasping for air when talking and a throat clearing cough. The pt's implanting surgeon reported that the trauma caused the side effects after the accident. It was additionally reported that they checked the device and it is still stimulating. Good faith attempts are underway for further details surrounding this event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2083000
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« Reply #51 on: March 21, 2016, 12:45:55 AM »

Model Number 103
Event Date 11/01/2010
Event Type Injury
Event Description
It was initially reported by the nurse that the pt was hospitalized for aspiration problems and she was not sure if this was related to vns. She state that the pt has many issues not related to vns and pt is a very difficult case to handle. The nurse was informed to turn off the device and see if the problem resolves. Good faith attempts to obtain additional information has been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1938615
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« Reply #52 on: March 30, 2016, 08:02:55 AM »

Model Number 102
Event Date 12/13/2009
Event Type Death
Event Description
It was reported that a pt passed away. F/u with the surgeon revealed that the pt had developed left vocal cord paralysis eight months prior (captured in mdr 1644487-2010-00350) as a result of lead revision surgery. The pt had some ongoing right sided paralysis for unk reasons and this did not appear to be related to the device. The pt required a tracheostomy and was following an otolaryngologist for the right side paralysis and did show some improvement. The pt later died due to aspiration with the vocal cord paralysis listed on the death certificate as a contributory factor. The manner of death was listed as "natural" on the death certificate. No autopsy was performed and the pt was buried with the device still implanted. Good faith attempts to obtain additional info regarding the pt's death from the pt's neurologist have been unsuccessful to date.

Manufacturer Narrative
Pt death believed to be a result of aspiration with vocal cord paralysis listed as a contributory factor. The left vocal cord paralysis is the result of the implant procedure and is captured in mdr 1644487-2010-00350.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1614851
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« Reply #53 on: April 01, 2016, 02:42:19 AM »

Event Date 06/08/2009
Event Type Injury
Event Description
It was reported in a scientific article that a vns pt presented via the emergency department following a series of six to eight seizures over 24 hours. The pt remained in an uncharacteristically protracted post-ictal state, and developed intermittent stridor associated with respiration embarrassment and hypoxia. Intercurrent vomiting episodes, coupled with widespread pulmonary crepitations, led to a provisional diagnosis of aspiration with laryngospasms. Treatment with continuous positive airway pressure ventilation, intravenous steroids and nebulised bronchodilators improved oxygen saturation, and normal consciousness returned. The stridor continues and was noted to be intermittent and not associated with desaturations. The pt was also noted to be aspirating on feeding. Furthermore, flexible laryngoscopy at rest revealed both vocal cords to be lying in a paramedian position during quiet respiration. During stridulous episodes, the glottis was noted to narrow further, with adduction of the left vocal and vestibular fold. It was suspected that vagus nerve stimulation was contributing to laryngeal dysfunction so the device was programmed off. Subsequent flexible laryngoscopy revealed a fully mobile left vocal fold but persistent right vocal fold palsy. At the moment, it is known that the vagus nerve stimulator remains programmed off and alternative medical therapy was initiated for seizure control. However, good faith attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Article citation: bhatt, y. M. , and hans belloso. "airway compromise secondary to vagus nerve stimulator: case report and implications for otolaryngologists. " the journal of laryngology & otology 3rd ser. 1 (2009): 1-3. Print.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1520362
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« Reply #54 on: April 03, 2016, 02:08:43 AM »

Model Number 103
Event Date 10/01/2011
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was initially reported that the patient began having an increase in seizures 5-7 days after having their vns generator initially turned on. The patient was also experiencing behavior changes. The patient exhibited aggression and weeping. The patient has experiencing weeping with seizure activity but never experienced aggression. The patient was recently confused and forgot to take their medication on schedule. This resulted in the patient aspirating during and seizures have having to be hospitalized. The generator was disabled while in the hospital.
 
Event Description
Additional information was received that indicated that the increase in seizures were not related to vns but were due to the patient missing a dose of medication. No further information was provided.
 
Event Description
Good faith attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2331542
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« Reply #55 on: April 04, 2016, 02:09:25 AM »

Model Number 102
Event Date 07/28/2009
Event Type Injury
Event Description
It was reported that the patient went to the er and had a pulse rate of 49 bpm. The patient's device was programmed off to rule out vns as a contributing factor. Per the reporter, he does not think the low pulse rate is due to the vns since it did not change much even after he turned off the device. The patient also had an episode of aspiration and was admitted to the hospital and intubated. Per the reporter, the patient has parkinson's disease, so there are a lot of health issues. Attempts for further information have been successful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1456772
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« Reply #56 on: April 04, 2016, 02:09:58 AM »

Model Number 103
Device Problem Device Operates Differently Than Expected
Event Date 05/18/2015
Event Type  Injury   
Event Description
It was reported that the patient had reported to the neurologist and ent physician that he had vocal cord paralysis, which the patient believed may be permanent and was from vns stimulation. The paralysis was reported to be on the left side. Following the initial implant surgery, the patient was set to 0. 25 ma output current, which he tolerated. At the first titration, the patient was moved from 0. 25 ma to 0. 5 ma. At 0. 5ma the patient showed symptoms of hoarseness. The patient was then moved to 0. 25ma and the issue persisted. The vns was then set to no longer deliver therapy and the hoarseness persisted which led to the referral to the ent additional information was received that following the vns implant surgery, the patient was reportedly doing well with no hoarseness at all. When the vns was turned to begin to deliver therapy, the patient became hoarse. Per the surgical report the physician obtained, this issue was not surgical. Per this patient, this issue occurred almost immediately after the vns was turned on. It began 10 days after implant around the time of his first titration. The ent physician did not believe the issue was permanent, however, and believed the issue would resolve with time. It was reported that the patient had already shown improvement between (b)(6) 2015 when he first presented to the ent with full left vocal cord paralysis and his next appointment on (b)(6) 2015. No known surgical interventions have been taken. No additional relevant information has been obtained to date.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
The previously submitted mdr inadvertently omitted the patient's report of aspiration and dysphagia.
 
Event Description
When the patient presented to the ent with vocal cord paralysis, the patient was also experiencing mild aspiration and dysphagia. This information was inadvertently not reported on the previously submitted mdr.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5027685
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« Reply #57 on: April 08, 2016, 01:18:45 AM »

Model Number 103
Event Date 01/01/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient is aspirating. The physician programmed the device off to see if the patient improves. The mom was not sure exactly when this issue began. The patient's device was then turned back on but he was still aspirating even with it off. The patient was going to undergo more tests to evaluate relationship to vns or other factors including a family history of muscle disorder.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5515506
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« Reply #58 on: April 09, 2016, 07:05:12 AM »

Event Date 05/01/2002
Event Type Injury
Event Description
It was reported in a scientific article that a vns pt experienced severe dysphagia, vocal cord paralysis and aspiration. "on the 15th postoperative day the pt was readmitted in the hospital with sudden onset of hoarseness and dysphagia. According to her caretakers, she was seen twisting the pulse generator under her skin a few days before admission. A check of the device with the programming wand showed that it was functioning normally. The chest x-ray obtained at this admission demonstrated excessive twisting of the leads cranial to the pulse generator. The otolaryngology service was consulted, and flexible laryngoscopy revealed left vocal cord paralysis with loss of sensation to the supraglottic airway" the pulse generator was surgically removed, and although the vagus nerve appeared intact, the leads were tangled, tightly twisted and completely separated from the spiral electrodes at the anchoring site. Because of the severe dysphagia the pt also underwent a percutaneous endoscopic gastrectomy three days after vns implantation surgery. The pt was readmitted to the hospital 10 days later for recurrent aspiration. The pt underwent vocal fold injection of gelfoam into the left periglottic space which ameliorated the aspiration. According to the author, "the pt continues to have complete vocal cord paralysis on long term review". Good faith attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Article: kalkanis, james, priya krishna, jose espinosa, and dean naritoku. "self-inflicted vocal cord paralysis in pts with vagus nerve stimulators. " (2002): 949-51. See scanned pages.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1408594
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« Reply #59 on: June 09, 2016, 01:10:46 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 11/01/2011
Event Type Injury
Event Description
It was reported by the physician the patient was unable to tolerate higher vns therapy settings due to excessive salivation and aspiration after the vns was implanted (b)(6) 2011. However, it was also reported the patient did see some disease improvement with vns therapy.

Event Description
It was reported by the physician that no interventions were taken in regards to the reported excessive salivation and aspiration. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5109166
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« Reply #60 on: September 09, 2016, 04:58:01 AM »

Model Number 106
Event Date 07/01/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that a patient was being evaluated for aspiration. The patient's mother did not believe he was aspirating because he could eat and drink at home. However, the patient would not drink the barium dye for a swallow study because he did not understand that it was a medical test and did not want to drink it. The patient's mother also reported that the patient's throat was vibrating, which is why the physicians believed that the patient was aspirating. The patient had stayed in the hospital for four and a half days, but no information was available if the hospitalization was for the aspiration or swallow study. The patient's mother later reported that someone at the patient's school said that they saw the patient aspirate, so the patient was referred for the swallow study that he failed for not swallowing the barium dye. The patient's mother refused to have the patient's vns disabled during the swallow study. The physician recommended programming the device off or placing the magnet over the patient's vns during lunch, and training for the school staff was offered. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5895404
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« Reply #61 on: November 29, 2016, 01:39:54 AM »

Model Number 102
Event Type Injury
Event Description
It was reported by the patient mother that the patient had difficulty eating and drinking during vns stimulation and would aspirate his food and water. The patient was diagnosed twice with pneumonia. It was suggested the patient receive a feeding tube; however, the neurologist suggested turning the vns off during mealtimes, and this has corrected the issue to the family satisfaction. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6030527
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« Reply #62 on: December 09, 2016, 10:46:06 AM »

Model Number 106
Event Date 10/01/2015
Event Type Injury
Event Description
It was reported that vns patient has swallowing problems. The patient has to be fed with liquid foods. However, the patient did benefit from vns therapy as the patient is now almost seizure free. Phone call received from the patientfather indicated that the swallowing started on (b)(6) 2015 and unknown if this is associated with vns stimulation. The patient was hospitalized from (b)(6) 2016 due to epilepsy seizures and from (b)(6) 2016 due to silent aspiration. It was also reported that the tube placed for the patient was initially made to dose the medicaments, this was later also used to fed the patient due to the swallowing difficulties. It was also reported that patient was followed up by ent doctor and logopedist for his health state.

Manufacturer Narrative
Udi-no. : (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6081301
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« Reply #63 on: December 09, 2016, 10:46:42 AM »

Event Date 09/28/2016
Event Type Injury
Manufacturer Narrative

Event Description
The patient had vns replacement surgery on (b)(6) 2016. The surgery was initially said to have gone fine by the surgeon and as far as he knew, the patient left the hospital on the same day of surgery and he was unaware of any adverse events. But after the surgery, the patient began to have fevers, cough, and loose stools and had to be hospitalized in the icu. It was initially thought the patient was septic, but now it is thought that the adverse events are being caused by the patient having aspirated during the vns implant surgery. The neurologist was not aware of any adverse events occurring. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6112523
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« Reply #64 on: December 09, 2016, 10:47:32 AM »

Event Date 04/09/2009
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Event is a direct result of the implant procedure.

Event Description
It was reported that a pt developed left vocal cord paralysis immediately following lead revision surgery. The pt had some ongoing right sided paralysis for unk reasons and this did not appear to be related to the device. The pt required a tracheostomy and was following an otolaryngologist for the right side paralysis and did show some improvement. The surgeon indicated that the paralysis of the left side was related to the revision surgery. The pt later died approximately 8 months later as a result of aspiration with the vocal cord paralysis listed on the death certificate as a contributory factor. The pt's death is reported on mdr #1644487-2010-00347.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1615709
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« Reply #65 on: January 06, 2017, 08:28:21 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 11/02/2016
Event Type Injury
Event Description
Per the physician, the aspiration was the cause of the patient's vomiting and pneumonia. The physician could not be certain that the aspiration occurred during the patient's recent vns surgery. No additional relevant information has been received to date.

Event Description
The patient underwent generator and lead replacement on (b)(6) 2016. The surgery was reported to have gone well with no issues. On (b)(6) 2016 the patient vomited and then vomited again the next day. On the evening of (b)(6) 2016, the patient began to have seizures and was admitted to the icu. The patient then developed pneumonia and the pulmonologist theorized the patient might have aspiration pneumonia, but this has not been confirmed. The generator is currently programmed off and has not been turned on since the surgery. Attempts at additional information have been made, but no additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6141156
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« Reply #66 on: February 15, 2017, 02:52:57 AM »

Model Number 102
Event Date 01/26/2012
Event Type Injury
Event Description
Additional information was received indicating that the apnea and aspiration were not believed to be related to vns as the patient had these prior to being implanted. These events did not occur with stimulation and there were no causal/contributory programming or medication changes that preceded the onset of the apnea or aspiration. The patient has since received a g-tube and will undergo a 2nd sleep study for the apnea. No additional information was received.

Event Description
It was reported through clinic notes received on (b)(6) 2012, that the patient has a medical history significant for obstructive sleep apnea and aspiration. While it is known that the patient has a history of apnea pre-vns, it is currently unknown if the apnea is exacerbated by vns therapy. The relationship between the patient's aspiration and vns is also unknown. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2480386
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« Reply #67 on: February 15, 2017, 02:53:46 AM »

Model Number 102
Device Problem No Information
Event Date 12/14/2010
Event Type Death
Event Description
The patient's death certificate was obtained and reviewed. The cause of death was aspiration with respiratory arrest ((b)(6)) and seizure disorder ((b)(6)). Other significant conditions contributing to death but not resulting in the underlying cause of death were mental retardation and spastic quadriplegia. An autopsy was not performed, and the manner of death was natural. The patient was cremated. As the cause of death was aspiration, sudep is no longer suspected as a cause of death. Manufacturer follow-up with the funeral home revealed the vns was explanted prior to the cremation and given to a disposal company.

Event Description
Cause of death information obtained from the (b)(6) was reviewed by the manufacturer which indicated that the patient had died on (b)(6) 2010 due to causes of respiratory arrest; other and unspecified convulsions; foreign body in respiratory tract, part unspecified; inhalation and ingestion of other objects causing obstruction of respiratory tract. Other contributing factors were provided as unspecified mental retardation; spastic tetraplegia; osteoporosis, unspecified. A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of probable sudep. There is no allegation or other information indicating that the death is related to vns.

Event Description
Reporter indicated a vns patient had died. The circumstances of the death were described as: "during night time bed checks the direct support staff person went in and checked on him and found him. She called the nurse who started cpr and it was called when the ems arrived and took over. Pronounced by the coroner"; the patient lived in an assisted-care facility, indicating he was in a reasonable state of health. The patient was compliant with his medications, and had no history of cardiac or respiratory problems, or substance abuse. The patient was found unresponsive during a night check at the facility. It is not specified the patient was in his bed, but this is likely as it was nighttime. The death was also not witnessed. The patient had a history of nocturnal seizures but no febrile seizures. Vns provided a 25% reduction in seizures. The patient was receiving vns therapy at the time of death, but vns settings were not provided. The available information suggests the death is probable sudep. Per the reporter, the death was unrelated to the vns. Attempts for the death certificate and disposition of the vns device are in progress.

Manufacturer Narrative
Cyberonics, inc. Submits this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation, based on information that cyberonics has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.

Manufacturer Narrative
Date received by manufacturer, corrected data: inadvertently not provided in follow-up report #02. The received date for follow-up report #02 was 03/03/2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2480496
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« Reply #68 on: February 22, 2017, 02:38:58 AM »

Model Number 102
Event Date 02/15/2010
Event Type Injury
Event Description
Initial reporter indicated that a vns pt was admitted to icu with pneumonia. Reported that they had aspirated and were experiencing dysphagia. Good faith attempts are being made for further info about the reported events. Thus far, no further info has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1631439
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« Reply #69 on: March 02, 2017, 12:43:49 AM »

Model Number 105
Event Date 01/18/2012
Event Type Injury
Event Description
It was reported that a vns pt developed pneumonia following generator and lead replacement surgery on (b)(6) 2012. The pt is being treated with antibiotics. The surgeon indicated that the pt likely aspirated after surgery. No additional info was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2434342
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« Reply #70 on: April 19, 2017, 12:19:41 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 10/15/2014
Event Type Death
Manufacturer Narrative
Device evaluated by manufacturer, additional information: device evaluation is not required because there is no suspected relationship of the death to the vns device.

Event Description
It was reported that a patient had passed away due to vomiting and suffering from aspiration. The patient suffered a severe drug-resistant epileptic encephalopathy. Additional information was received from the patient's physician indicating that the death was not related to vns, that the patient had responded to vns therapy and experienced a reduction in seizures as a result, and the patient was receiving vns therapy at the time of the death. The patient's device was not explanted and no autopsy was performed. The patient did not have a history of drug or alcohol abuse and had no history of cardiac or respiratory problems. Information was later received via an article entitled "adverse effects and surgical complications in pediatric patients undergoing vagal nerve stimulation for drug-resistant epilepsy" where the physician indicated that the patient had passed away due to sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6420763
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« Reply #71 on: April 19, 2017, 12:20:23 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 08/10/2013
Event Type Death
Manufacturer Narrative

Event Description
It was found through obituary that the patient passed away at a hospital, where he lived and was treated by his following neurologist. The patient's death discharge report indicated that the final cause of death was cardiopulmonary arrest secondary to possible aspiration pneumonia with not direct cause as: seizure disorder and paranoid schizophrenia. During the eight months prior to the patient's death, he became increasingly wheelchair bound and kyphoscoliotic, and was working with speech therapy for dysphagia. Two weeks prior to death, he had an episode of respiratory distress that led to intubation and icu stay; the patient chose comfort feeds as a method of treatment and developed increasing respiratory distress likely secondary to pneumonitis and aspiration that eventually led to his death. A battery life calculation found that the patient's generator was expected to have reached end of service approximately 10 months prior to the patient's death. No further relevant information has been received to date. The suspect product has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6404628
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« Reply #72 on: April 19, 2017, 12:21:00 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 02/28/2015
Event Type Death
Manufacturer Narrative

Event Description
It was reported that this patient passed away due to complications from a major seizure. The patient died due to aspiration related to the seizure. No further relevant information has been received to date. The suspect product has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6434911
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« Reply #73 on: May 04, 2017, 01:28:48 AM »

Model Number 103
Event Date 05/01/2014
Event Type Injury
Event Description
The physician reported that the patient's clinical symptoms improved after generator replacement.

Event Description
Clinic notes dated (b)(6) 2014 note that the patient's seizures have continued with six relatively mild type seizures within the past month. It was reported that the device is functional and is noted to be near end of service. The notes indicate that the patient has had some breakthrough events, and is having more choking and respiratory complications. It was noted that there is a possibility that the generator is causing complications as it is going out of service and should be reversible when generator is replaced. The notes indicate that the patient currently has recurrent respiratory complications including aspiration. The patient was referred for surgery. The physician reported that he does not believe anything is wrong with the device, but that the events were related to the battery nearing end of service. No known surgical intervention has been performed to date.

Event Description
An implant card was later received which reported that the patient had prophylactic generator replacement on (b)(6) 2015. The battery status was marked as not near end of service (neos-no). The explant does not return explanted products to the manufacturer for analysis per hospital policy.

Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported this data incorrectly.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3956176
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« Reply #74 on: May 07, 2017, 01:37:35 AM »

Model Number 103
Event Date 05/15/2014
Event Type Injury
Event Description
Additional information was returned on 01/14/2015 from the patient¿s physician. The relationship of the status epilepticus to vns was unclear as the episode occurred several days after the increase in vns parameters; however, subsequent increases in vns settings did not cause any problems. The patient was last seen on (b)(6) 2014 with only one seizure on (b)(6) 2014. Vns settings were currently at 2. 0 ma, and the patient tolerated this well. Clinic notes dated (b)(6) 2014 were also provided. The notes indicated that the patient¿s vns was being tolerated well: device settings were increased at this appointment. No changes in medication were made. Device diagnostics were also noted and appeared to be within normal limits.

Event Description
It was reported that the patient was hospitalized with status epilepticus. It was reported that device settings had been adjusted and then two days later the patient experienced sixteen seizures back to back. Diastat was used, but was ineffective. During hospitalization the patient vomited and aspirated the vomit. The patient was intubated as a result of the aspiration. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3883979
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« Reply #75 on: May 07, 2017, 08:05:38 AM »

Model Number 103
Event Date 08/08/2016
Event Type Death
Event Description
Additional information was received from the facility. It indicated that the believed cause of death could be seizure related - aspirated. The death was witnessed in hospital and the circumstance of death, as reported, was: seizure related - prolonged seizure - aspirated. It was reported that the cause of death is believed to be not related to vns therapy. The patient response to vns therapy was seizure reduction. It was reported that the patient was recently suffering from aspiration pneumonia and peg (gastrostomy). The patient underwent surgery recently. It was reported that an autopsy was performed. It was reported that the patient's device was explanted after the death. The explant date is unknown and the explanted device was not returned to the manufacturer to date. It was reported that the patient had a story of nocturnal seizures but no story of febrile seizures. The patient did not undergo resective epilepsy surgery. But the patient had a history of chest infections in the past.

Event Description
It was reported that a vns patient died on (b)(6) 2016. It was reported that they are planning to explant the device. No additional information was provided to date. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5927525
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« Reply #76 on: May 14, 2017, 01:02:31 AM »

Event Date 01/01/1998
Event Type Injury
Event Description
It was reported in a article that two children showed an increased degree of aspiration during continuous vns stimulation evaluated by videoradiography during barium swallow. Both children with the increased degree of aspiration had severe mental retardation and motor retardation and were dependant on assisted feeding. Both children showing the increased aspiration have a severe mental and motor impairment. Reference mdr number: 1644487-2008-02052 for the other child.

Manufacturer Narrative
Reference article: lundgren j, ekberg o, olsson r. Aspiration: a potential complication to vagus nerve stimulation. Epilepsia 1998;39 (september):998-1000.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1143663
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« Reply #77 on: June 09, 2017, 02:45:38 AM »

Model Number 106
Device Problem No Known Device Problem
Event Type Malfunction
Event Description
It was reported that the patient was in the icu due to pneumonia from aspiration not related to the vns device. The patient's mother wanted the patient's vns device to be adjusted due to an increase in seizures that the patient had been experiencing. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6578153
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« Reply #78 on: August 04, 2017, 03:33:17 AM »

Device Problem No Information
Event Date 01/01/2014
Event Type  Malfunction   
Event Description
It was reported via an internet forum by an unknown patient that the physician observed their vns device "wasn't working for some reason. " the patient was referred for exploratory surgery due to the issue with the device. During the exploratory surgery it was found that scar tissue had developed around the generator and lead. The lead and generator were both replaced at that time and the generator was noted to be at a low battery condition. No additional relevant information had been received to date. Following the surgery, the patient experienced issues with vocal cord paralysis and aspiration. These events were reported in mfg report # 1644487-2017-04147.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6724349
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« Reply #79 on: August 04, 2017, 03:33:50 AM »

Device Problem No Known Device Problem
Event Date 01/01/2014
Event Type  Injury   
Event Description
It was reported via an internet forum by an unknown patient that they required a full revision for a malfunction reported in mfg report # 1644487-2017-04146. Following the surgery one of the patient's vocal cords was paralyzed. The patient required a second surgery due to aspirating while eating and drinking. The paralysis was stated to resolve after three months. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6724547
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« Reply #80 on: August 04, 2017, 03:34:20 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 01/01/2006
Event Type  Injury   
Event Description
A patient's wife reported that her husband's vns stimulation caused the patient to have difficulty swallowing, which led to the patient aspirating on a milkshake and having aspiration pneumonia. The patient's device was disabled due to the aspiration risks associated with the stimulation. A review of the available programming and diagnostic history showed proper device functionality for the first year the device was implanted. Attempts were made to the patient's current treating neurologist who had no information regarding the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6728448
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« Reply #81 on: August 04, 2017, 08:19:00 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 08/25/2016
Event Type  Injury   
Event Description
It was reported that the patient tolerated vns therapy on a daily basis however when he used the vns magnet to activate the magnet mode stimulation the patient coughed. The physician speculated that this may have contributed to aspiration. The settings were then adjusted. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6729011
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« Reply #82 on: September 22, 2017, 01:23:13 AM »

Model Number 103
Device Problem No Information
Event Date 02/18/2012
Event Type  Death   
Event Description
No further information has been received at this time in regards to the cause of this patient's death. The doctor who had been following the patient found out second hand the patient had died. They had no information. The doctor felt like the vns would not have played a part as the patient had a lot of comorbid conditions ie had been hospitalized for 6 months prior to getting vns. No specifics of their cause of death known.
 
Event Description
Information was received from a neurology office that a vns patient's died. Good faith attempts are underway for further details about their death. At this time no further information has been attained.
 
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient's cause of death was "pneumonitis due to food and vomit; other and unspecified convulsions. " there is no allegation or other information indicating that the death is related to vns.
 
Manufacturer Narrative

Manufacturer Narrative
Describe event or problem: corrected data omitted off original mdr report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2707022
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« Reply #83 on: October 02, 2017, 12:41:36 AM »

Model Number 103
Event Date 12/25/2012
Event Type  Death   
Manufacturer Narrative

Event Description
New information was received indicating that the implanted vns products were not explanted prior to the funeral.
 
Event Description
Hold. Ng 1/2/13. The reporter indicated that a vns patient was admitted to the hospital on (b)(6) 2012 due to seizures, where the patient later exhibited additional adverse events which included asystole, bradycardia, aspiration, and coughing. The patient latter died on (b)(6) 2012 at 4am in the hospital due to cardiac arrest, and the death was witnessed. X-rays reviewed by the manufacturer on (b)(6) 2013 noted no anomalies. The reporter later stated that the coughing and aspiration were related to pneumonia, and that the increase in seizures was related to the fact that the patient is known for "periodic flurries of seizures. " after the patient was hospitalized the vns was disabled using the magnet, and bradycardia recovery was noted. The reporter also stated that the patient had four heart attacks before the vns was implanted. The concurrent illnesses/diseases include pneumonia, developmental delay, heart attacks (x4), stroke, lung cancer, cerebral palsy, absent corpus callosum, and mental retardation. It was not known to the reporter if the vns was explanted after death. It is not known if an autopsy was performed. The reporter stated that he tried to obtain information from the hospital staff that regarding the patient's condition, but they did not respond. The physician stated that the patient was very ill who was in his 20's with a "5 year-old body", and had bad seizures, no corpus callosum, suffered a stroke and had a peg tube all before the vns was implanted. The patient's medications were changed on (b)(6)2012 to compensate for the vns being disabled with the magnet. Per the reporter, the relationship of the death to the vns is unknown.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2930248
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« Reply #84 on: October 16, 2017, 01:12:19 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 08/15/2012
Event Type Death
Event Description
Cause of death information obtained from the (b)(6) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2012 and the patient's cause of death was pneumonitis due to food and vomit, septicemia, insulin-dependent diabetes mellitus without complications, infantile cerebral palsy, essential (primary) hypertension, cardiac arrest, pneumonia, and respiratory failure. There is no allegation or other information indicating that the death is related to vns.

Event Description
On (b)(6) 2013, it was reported that the physician's office had called the patient to schedule an appointment, but were told by his caregiver that the patient had passed away. Follow up with the physician's office found that they had no information on the patient's death, including the cause. Follow up with the caregiver found that the patient passed away on (b)(6) 2012. The caregiver speculated that the death may have been from an infection or from cardiac arrest; however, this has not been confirmed. The patient's primary care physician's information was provided, but no other information was known. Attempts have been made for additional information from the primary care physician; however, they have been unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3147978
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« Reply #85 on: October 27, 2017, 07:40:47 AM »

Model Number 103
Event Date 09/10/2012
Event Type Injury
Event Description
It was reported that the patient has been admitted to the hospital multiple times in 2013 due to aspiration. It was reported that the patient experienced aspiration prior to vns, but that vns may have increased the occurrence of aspiration. It was reported that the patient's aspiration often occurs following tonic-clinic seizures, but that for aspiration that does not occur with seizures the magnet is utilized to disable the device while the patient eats. It was reported that aspiration is due to the patient's disease progression. The patient was hospitalized from (b)(6) 2013 for aspiration pneumonia. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3703056
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« Reply #86 on: October 30, 2017, 02:51:40 AM »

Model Number 103
Event Date 10/31/2012
Event Type Injury
Manufacturer Narrative

Event Description
All attempts for additional information have been unsuccessful to date.

Event Description
Reporter indicated via clinic notes received that a vns patient was experiencing aspiration on the clinic notes dated (b)(6) 2012. The patient also had a swallow study. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2856453
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« Reply #87 on: November 02, 2017, 01:33:13 AM »

Model Number 102R
Event Date 09/09/2007
Event Type Death
Event Description
It was reported that the vns patient passed away. The cause of death is unknown. The relationship of vns to the cause of death is unknown. The funeral home reported that they do not remove medical implants unless it¿s necessary due to cremation or rare other occasions such as patient ¿s family or medical device company requesting prior to burial. Therefore, there is no record that it was explanted. Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description
Additional information was received via cdc national death index where it was found that the underlying cause of the patient¿s death was ¿pneumonitis due to food and vomit¿ with record axis of ¿unspecified mental retardation¿, ¿infantile cerebral palsy, unspecified,¿ ¿cardiac arrest, unspecified¿ and ¿respiratory failure, unspecified. ¿.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3937871
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« Reply #88 on: November 17, 2017, 03:55:54 AM »

Model Number 105
Event Date 02/27/2015
Event Type Injury
Manufacturer Narrative
This information was inadvertently left off of initial mfr. Report. This information was inadvertently left off of previous mfr. Report: suspected device udi: (b)(4).

Manufacturer Narrative

Event Description
This event was not a serious event and should not have been reported. Settings changes were reported to be for patient comfort.

Event Description
It was reported that at the patient's two week vns post implant check the patient experienced coughing and gasping with magnet mode stimulation. It was reported that the patient would aspirate after gasping. The device pulse width was adjusted from 500 usec to 250 usec which resolved the coughing. The patient was seen again at which time it was reported that the patient was tolerating the settings well. The patient's mother clarified that when the magnet would be used the patient would gasp and then aspirate and cough. Since the patient was reported to be doing well the physician's assistant increased the settings. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4702373
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« Reply #89 on: November 23, 2017, 02:32:28 AM »

Model Number 104
Device Problem No Known Device Problem
Event Date 06/09/2015
Event Type Death
Event Description
Follow-up to the physician at the patient's group home revealed the patient's cause of death was respiratory failure, restrictive lung disease due to scoliosis, and aspiration pneumonia due to dysphagia. The physician stated that vns did not contribute to the dysphagia or the cause of death.

Event Description
It was reported that the vns patient passed away on (b)(6) 2015. The cause of death and its relationship to vns are unknown. It was noted that the patient had been hospitalized the past month due to fever and aspiration unrelated to vns. No further information relevant to the event has been received to date. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep.

Manufacturer Narrative
Suspect device udi: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4889279
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« Reply #90 on: November 23, 2017, 02:33:13 AM »

Model Number 102
Event Date 11/15/2013
Event Type Death
Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
It was reported that the patient passed away on (b)(6) 2013 due to inhalation and ingestion of food causing obstruction of respiratory tract. Patient also had dementia and chronic ischemic heart disease.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4933194
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« Reply #91 on: November 23, 2017, 02:33:52 AM »

Model Number 103
Event Date 08/23/2011
Event Type Injury
Event Description
Clinic notes received for patient indicate that the patient had several instances of aspiration. The aspiration is believed to be due to vns stimulation and vns settings were decreased as a result.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4907255
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« Reply #92 on: December 06, 2017, 02:47:49 AM »

Model Number 102
Device Problem No Information
Event Date 04/09/2014
Event Type Death
Event Description
It was found that in the state of (b)(6), vital records are not open to the general public and can only be obtained by the individual, guardian, or other legal party and the death certificate will not be able to be obtained from the state of missouri by the manufacturer.

Manufacturer Narrative

Manufacturer Narrative
Outcomes attributed to adverse event: death. Initial mdr inadvertently omitted outcome attributed to the adverse event and date of death. Type of reportable event: death. Initial mdr inadvertently marked the type of reportable event as serious injury instead of death.

Event Description
It was reported by the funeral home the patient had a graveside burial. It was noted the patient probably did not have the vns device explanted as it was just a burial. Attempts for additional relevant information have been unsuccessful to date.

Event Description
It was reported through hospital notes received by the manufacturer that the contributing factors to the patient's death were aspiration, refractory seizures, and history of renal cell cancer. The contributing factors for the patient's admission to the hospital were thrombocytopenia, seizure disorder, and hypernatremia. No additional relevant information has been received to date.

Event Description
It was reported by the physician that the patient had deceased. An obituary was found which found the patient had passed away on (b)(6) 2014. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5193626
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« Reply #93 on: December 10, 2017, 01:54:32 AM »

Model Number 102
Event Date 06/01/2015
Event Type Death
Manufacturer Narrative

Event Description
Clinic notes were received regarding the patient's reason for admission to the hospital and her death. It was noted the patient was admitted to the hospital on (b)(6) 2015 and discharged on (b)(6) 2015. It was noted that the day before she was admitted, she was on the toilet and fell to her side, injured her left ribs, but the staff did not think too much about it because she did not really complain. But, as time went on, she started complaining more of shoulder pain, breast pain, and lateral chest pain, so they brought her into the e. R. Where 2 fractured ribs on the left anterolateral side were found. It was felt by the physician that the patient should be admitted so that they could observe her. The patient was admitted and had no problems over the weekend. On monday morning, the physician was told the patient had an arrest. He discussed with the physician on call and the nurse and it was explained that around 3 am the patient had some nausea and abdominal pain. They provided the patient with zofran and then when they went to check on her again, she had vomited and it was noticed she has some pudding around her mouth. At that time, she was just staring and then just "went out. " a sternal rub was performed and a code was called, but they were unsuccessful. It was decided the patient most likely aspirated and an autopsy was not performed.

Event Description
It was reported by the company representative that the patient had passed away. An obituary search provided the date of the patient's death, but no cause of death was provided. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5463400
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« Reply #94 on: December 30, 2017, 02:16:47 AM »

Model Number 104
Event Date 07/21/2014
Event Type Injury
Event Description
It was reported that following generator replacement surgery on (b)(6) 2014, the patient began experiencing hypoxia and aspiration. The patient immediately began aspirating following replacement surgery and was taken to the er. In the er, the patient was diagnosed by an ent physician with left vocal cord paralysis which is believed to be due to the replacement surgery, a possible stroke, or an endotracheal tube. The physician stated that the patient¿s symptoms should improve in approximately six months. It was noted that the patient continued to have seizures and that the patient began complaining about stimulation on-times. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4080441
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« Reply #95 on: January 04, 2018, 02:33:25 AM »

Model Number 102
Event Date 10/31/2016
Event Type Death
Event Description
It was reported that the patient passed away from aspiration. The patient had a history of obstructive sleep apnea. It was stated that this was not related to vns therapy and vns therapy helped reduce seizure frequency.

Manufacturer Narrative

Event Description
It was reported on (b)(6) 2016 that the patient passed away and it was stated to be probable sudep. An obituary search showed that the patient died on (b)(6) 2016. The patient was buried with the device therefore it is not available for return. It was also indicated by the funeral home that the patient died of cardiac arrest. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6156291
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« Reply #96 on: March 10, 2018, 02:48:21 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 05/01/2015
Event Type Injury
Event Description
It was reported that shortly after the patient's vns was replaced, the patient experienced coughing and aspiration. As a result, the patient's device was disabled. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7239879
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« Reply #97 on: April 15, 2018, 12:48:16 AM »

Model Number 102
Device Problem No Information
Event Date 05/28/2012
Event Type  Death   
Event Description
Cause of death information obtained from the (b)(6) was reviewed by the manufacturer which indicated that the patient's cause of death was respiratory failure. It was noted that the cause of death was pneumonitis due to food and vomit. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
Confirmation was received from the physician¿s office that this the reported patient in supplemental report #1 was the patient who passed away.
 
Manufacturer Narrative

Event Description
The company representative found information that may suggest the patient¿s device is sn (b)(4) which was tied to a patient implanted on (b)(6) 2007 and was treated by the same physician¿s office. Attempts for confirmation from the physician¿s office that this is the patient who passed away have been unsuccessful to date.
 
Event Description
This death information has been reviewed and with the available information has been determined to be possible sudep by the manufacturer¿s nurse as the cause of death is unknown with the available information. Obituary was found online which reported the patient passed away on (b)(6) 2012. Follow-up with the funeral home indicated that there were no records of the vns devices being explanted prior to burial.
 
Event Description
A nurse at the physician' office reported that a patient passed away approximately six months ago. She did not know the exact date or reason why. She indicated she had just recently found out. Attempts for additional information from the nurse and physician's office have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3085402
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« Reply #98 on: April 26, 2018, 01:31:37 AM »

Model Number 102
Event Date 06/01/2013
Event Type  Death   
Event Description
On (b)(6) 2013 it was reported that the vns patient passed away on (b)(6) 2013 due to choking on a sandwich. Good faith attempts were made to physician but were not successful.
 
Manufacturer Narrative

Event Description
Additional information was received that the patient died of asphyxia by bolus of food. The generator and lead were returned to the manufacturer for evaluation. The generator output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Note that the majority of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device. Note that since the majority of the lead assembly (body), including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3195325
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« Reply #99 on: May 02, 2018, 02:05:56 AM »

Model Number 102
Event Date 06/12/2008
Event Type  Injury   
Event Description
Reporter indicated a vns patient presented with excessive drooling. The patient's mother stated the patient had a stroke as a result of brain surgery. After the stroke, the patient began to have drooling issues. The drooling got better, but did not resolve with setting adjustments. A fluoroscopy determined the patient would aspirate liquids and is now having to "thicken" the patient's fluid intake. Device diagnostics are within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1150407
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« Reply #100 on: May 12, 2018, 01:36:17 AM »

Model Number 102
Event Date 09/04/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 indicated recurrent aspiration bronchitis/pneumonia and dysphagia (aspiration with a history of pneumonia) in the patient¿s past medical history. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3444161
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« Reply #101 on: June 10, 2018, 01:04:22 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 06/11/2008
Event Type  Injury   
Event Description
It was reported in 2012 that the patient's father called asking for the patient's records from time of implant until when the device was turned off. He believed that the vns almost killed her. Per the father, the patient had aspiration pneumonia and had been admitted to the emergency department. When follow-up was conducted with the physician¿s office in 2012, the physician¿s office stated that the patient had a past history of problems with aspiration even prior to the vns, so they didn¿t believe it was related to the vns or stimulation. The vns was turned off at the family¿s request approximately two months after implant. In 2018, further information from the father was received. He reported that the patient was now in respiratory failure and had had quite a few aspiration and pneumonia events. He stated that the patient hadn¿t had aspiration events prior to the vns. The father believed that one instance of aspiration pneumonia, that had occurred ¿a while ago,¿ had been caused by a feeding tube that he said was needed because the patient couldn¿t swallow due to the vns. Since then, the patient had had multiple instances of aspiration pneumonia due to influenza, which the father did not suspect were related to the vns. Later he indicated that the patient had had multiple aspiration pneumonia events due to the vns. The father reported that the patient had issues with the vns such as throat pain, inability to speak, and inability to swallow food. He said that the patient¿s vns had been disabled permanently between 2012 and 2014 because the patient¿s ent had attributed the dysphagia to the vns. Per the father the ent had looked at the patient¿s throat while the magnet was swiped and the patient¿s throat did not close. Per the father, because the patient¿s throat remained open, fluid and other things could get into lungs, leading to pneumonia. Finally, the father reported that the patient¿s physician had told him that there had never been any problem with the vns. Further follow-up with the physician¿s office found that this father frequently reported this complaint to them and that the patient was recently admitted to the hospital with pneumonia. The physician indicated that he couldn¿t provide an assessment of the events reported by the father until he saw the patient again. No further relevant information has been received, to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7497099
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« Reply #102 on: July 06, 2018, 11:10:43 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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« Reply #103 on: July 23, 2018, 04:04:49 AM »

Model Number 104
Event Date 09/18/2011
Event Type  Death   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
It was reported that an autopsy was performed so the vns system was most likely removed during the autopsy. The death certificate indicated that the patient died in the emergency department. The immediate cause of death is listed as chronic seizure disorder complicated by drowning. The manner of death was listed as accident and the injury was described as seizure in bathtub. The coroner indicated that he is certain the device was explanted; however, the facility indicated that they were unable to locate the device. The autopsy report did not list that the vns was explanted. The autopsy reported indicated that there was aspirated foreign material in the patient's airways. The final diagnosis was chronic seizure disorder complicated by drowning, status post implantation of vagal stimulation, cutaneous immersion changes, aspiration of gastric contents, pulmonary edema, and vascular ectasia of left dorsomedial thalamus. There were no significant injuries identified. It was noted that the descendent had an extensive seizure history and was found prone in a bathtub with his face underwater by a staff member of the group care home. Hospitalization records 5-6 months prior to the patient's death showed that the patient was hospitalized from (b)(6) 2011 for physical aggression towards caregivers. The patient was experiencing auditory and visual hallucinations. The patient was discharged in stable condition. The patient was hospitalized again from (b)(6) 2011 due to agitation and abusive behavior toward the care facility staff. The patient was discarded as improved and more stable.
 
Event Description
An obituary search on (b)(6) 2013 showed that this vns patient had passed away on (b)(6) 2011. The patient had been lost to follow-up, and the most recent physician did not know the patient¿s whereabouts. Follow-up with the funeral home showed that the location of the patient¿s device was unknown: it was unknown if the patient was buried with the device. Review of programming history showed that the patient¿s device was still programmed on as of (b)(6) 2011.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3548834
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« Reply #104 on: September 14, 2018, 08:10:35 AM »

Event Date 07/01/2009
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was initially reported that the patient was sent to a gastroenterologist for consult due to aspiration problems. The patient is pending an egd test and if there is a need for a g-tube or fundoplication surgery. The vns was not turned off by the neurologist completely but the settings were turned down and pt only gets 7 seconds of stimulation every "so often" (timing is unknown). The relationship of the therapy to the aspiration is unclear at this time. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1464448
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« Reply #105 on: November 08, 2018, 02:05:13 AM »

Model Number 103
Device Problem Insufficient Information
Event Date 12/10/2012
Event Type  Death   
Event Description
All attempts for the autopsy results from the medical examiner's office have been unsuccessful to date.
 
Event Description
Reporter indicated the patient's death was not related to the vns, but the cause of the death is unknown and pending an autopsy. The death was not witnessed and no trauma occurred. The patient was noncompliant with taking his medications and did not keep regular office appointments. Attempts for the autopsy results are in progress.
 
Manufacturer Narrative

Event Description
Reporter indicated that a vns patient had died "peacefully in his sleep" on (b)(6) 2012. An online obituary noted the patient died at home as a result of his epilepsy. It is unknown if seizure activity preceded the death; as such sudep cannot be ruled out as a possible cause of the death. Attempts for additional information are in progress.
 
Event Description
An autopsy report for the patient was received to the manufacturer on (b)(4) 2013. Final autopsy diagnosis was "epilepsy, unspecified; oro-gastric aspiration, acute splenitis, pneumonia, hypoxic ischemic brain injury, subarachnoid hemorrhage, obesity, hepatic stenosis (mild), mild atherosclerosis of cerebral blood vessels, and superficial abrasions". The manner of death was natural. Blood tests did not detect any anti-epileptic drugs or illicit drugs. No significant injuries were present that caused the death. According to investigative reports, the decedent was found unresponsive after a seizure.
 
Event Description
Reporter indicated the vns device was explanted and discarded.
 
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2012 and the patient's cause of death was epilepsy, which was contributed by obesity, pneumonia, foreign body in respiratory tract, and inhalation of gastric contents. A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of definite sudep. There is no allegation or other information indicating that the death is related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2904662
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« Reply #106 on: November 12, 2018, 07:56:10 AM »

Model Number 304-20
Event Date 01/17/2013
Event Type  Injury   
Event Description
Additional information was received from the patient that she was diagnosed with left vocal cord paralysis by an ent. The patient reported that she is still having a hard time drinking liquids and regular foods. Clinic notes from the ent follow-up dated (b)(6) 2013 note that the patient experiences aspiration symptoms with think liquids and that she is on a thickened liquid diet. The notes also indicated that the patient is currently working with speech. Clinic notes dated (b)(6) 2013 indicated that the patient was improved since her last evaluation and that she was doing better with swallowing; however, that she was still on liquids. It was noted that her voice was stronger and that she would be sent for ent evaluation. Attempts for additional information have been unsuccessful to date.
 
Event Description
Reporter indicated that she was admitted to the hospital the day after implant surgery for difficulty swallowing. The patient also reported that she was still having difficulty and was using liquid thickener to help. Further follow-up revealed that the patient was doing much better. Physician indicated that the patient has a "thick neck" and there was a lot of manipulation which caused swelling which caused the patient's swallowing issues. The physician indicated that the patient was doing much better.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2962368
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« Reply #107 on: November 27, 2018, 08:16:18 AM »

Model Number 101
Event Date 01/01/2006
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2016 noted that the patient's device had to be programmed off due to aspiration after vns implant. The patient underwent peg tube placement as a result of the aspiration. Review of in house programming history identified that the vns was programmed off on (b)(6) 2006 and there is no history available indicating the device was turned back on. Further follow up with the patient's current treating neurologist identified that the aspiration has resolved and the peg was removed. The patient is now swallowing and breathing normally. The physician plans to program the device back on and titrate slowly to determine if the patient can now tolerate the vns. Attempts to obtain additional relevant information from the patient's previous treating neurologist and implanting surgeon have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5430731
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« Reply #108 on: December 23, 2018, 10:37:55 AM »

Model Number 103
Event Date 08/28/2013
Event Type  Injury   
Event Description
Additional information was received from the neurologist stating that following replacement surgery, the vns patient had severe difficulty swallowing, nerve damage, laryngeal issues, and aspiration. The patient¿s symptoms were reported to be somewhat better.

Manufacturer Narrative
Describe event or problem, corrected data: supplemental manufacturer report #01 inadvertently did not include the additional information received from the neurologist.

Event Description
On (b)(6), 2013, the patient's father reported that the patient has been experiencing several adverse events after having his most recent vns replacement on (b)(6), 2013. The adverse events included losing his voice, coughing and choking while he eats, aspiration pneumonia, and a hole in an unspecified location. Attempts for additional information have been made; however, they were unsuccessful. No additional information has been provided.

Manufacturer Narrative

Event Description
The patient was seen for follow-up with the surgeon. The device interrogation was within normal limits. The surgeon indicated that he initially thought the patient's issues were due to the patient being intubated for implant surgery. The surgeon indicated that the patient likely has recurrent left laryngeal polyps which he feels will continue to heal over the next six months. The surgeon offered the patient a follow-up appointment in three months. The surgeon reported that it is reasonable that scar tissue could have been dissected and such outcomes would be reasonable to occur.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3528864
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« Reply #109 on: January 11, 2019, 02:59:41 AM »

Model Number 103
Event Date 10/01/2010
Event Type  Injury   
Event Description
It was initially reported by the physician that the pt was admitted to an icu due to choking and aspiration and pt was "clawing at his vns. " diagnostics test was performed and confirmed that the device was functioning fine. Device was turned off due to the events. Good faith attempts to obtain additional info has been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1894924
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« Reply #110 on: March 05, 2019, 07:47:42 AM »

Event Date 07/06/2009
Event Type  Injury   
Event Description
It was reported that a vns patient experienced a decrease in mobility of the left vocal cord along with aspiration and difficulty swallowing three months post implant. The patient was evaluated by an ent physician who identified a positive vocal cord paralysis. Additional information received from the ent revealed the relationship of the vocal cord paralysis to vns is unknown. Good faith attempts to obtain product information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1445192
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« Reply #111 on: March 21, 2019, 01:22:00 AM »

Model Number 300-20
Event Date 06/17/1999
Event Type  Injury   
Event Description
It was reported by the physician that the patient had aspiration pneumonia. It was also stated the patient had partial left vocal cord paralysis (paresis) due to the vns implantation. It was reported the paresis makes aspiration more likely and causes the patient to choke while eating. The patient's food limitations have caused a lot of weight loss. However, the physician did not that the patient was scoped and an opening was seen that placed the patient at risk when he eats. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5200775
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