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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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
« Last Edit: January 04, 2018, 02:32:14 AM by dennis100 » Logged
dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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
« Last Edit: December 30, 2017, 02:15:55 AM by dennis100 » Logged
dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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