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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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