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dennis100
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« Reply #60 on: December 14, 2017, 03:33:17 AM »

Model Number 103
Event Date 01/29/2016
Event Type Death
Event Description
Follow-up information from the physician indicated that the patient's cause of death was abdominal sepsis / renal insufficiency, not related to vns therapy.

Manufacturer Narrative

Event Description
It was reported on (b)(6) 2016 that the patient died on (b)(6) 2016. The patient was implanted with vns on (b)(6) 2014. Attempts for additional information have been made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5499226
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dennis100
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« Reply #61 on: December 28, 2017, 02:24:01 AM »

Model Number 105
Event Type Injury
Event Description
It was reported that a vns patient was admitted to the icu with a fall. It was reported that the patient keeps going into status. It was reported that the patient's device would be checked. No additional information was provided to date.

Event Description
Additional information from the nurse indicated that it was felt the status was due to sepsis from his recent injury and nothing to do with vns. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. Later, it was confirmed by the nurse that the status was not due to vns, but sepsis related. It was reported that the vns patient has a history of previous status. The nurse reported that the patient's device was interrogated during a follow-up visit; its settings were: 1. 75ma output current - 30hz frequency - 250usec pulse width - 30sec on time - 3min off time - 2ma magnet output - 500usec mag pulse width - 60sec magnet on time. The device was tested and system diagnostics returned impedance results within normal limits with 2671 ohms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5966409
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dennis100
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« Reply #62 on: December 29, 2017, 02:00:36 AM »

Model Number 103
Event Date 08/30/2015
Event Type Death
Event Description
On (b)(6) 2016 it was reported that a patient passed away on (b)(6) 2015. The cause of death is unknown. A battery life calculation indicated that the patient's generator should have been working at the time of their death since nearly a year later there was still 0. 3 years remaining. No further relevant information has been received to date.

Event Description
The death certificate was received on 10/03/2016. The patient's death discharge summary from the hospital, he passed away in states that the patient has had several hospital admissions for his chronic inflammatory demyelinating polyneuritis and was recently diagnosed with b-cell lymphoma and started on chemotherapy. He was able to be stabilized and discharged home. However, he returned to the hospital on (b)(6) 2015 due to fever. Patient was admitted to icu and given antibiotics for sepsis and supportive care. Patient had issues with tachycardia and chronic respiratory failure likely due to the chemotherapy. Patient continued to show evidence of failure to thrive and eventually passed. The cause of death was sepsis and chronic inflammatory demyelinating polyneuritis along with heart failure.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5959999
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dennis100
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« Reply #63 on: December 31, 2017, 02:26:48 AM »

Model Number 106
Event Date 09/28/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient underwent prophylactic generator replacement surgery. Diagnostic testing at the surgery showed that the generator was functioning properly. It was then programmed on following the surgery. A week later, the patient was experiencing an increase in seizures after missing doses of antiepileptic drugs for several days. She presented to the hospital in a status epilepticus state with symptoms that suggested the patient was suffering from meningitis and/or sepsis. Lab results showed the patient had elevated levels of white blood cells which led to concerns of a possible infection. The generator incision site was evaluated and it was noted that there were no sign of an active infection as the wound was dry and healing well. There was no erythema or purulence observed around the generator. The neurosurgery department did not suspect that the symptoms of sepsis were related to the recent generator replacement surgery. However due to the timing of events, the surgery was not ruled out as a possible contributing factor at the time. Manufacturing records showed that the generator was sterilized prior to distribution. The patient was then admitted to the intensive care unit where she was intubated, an eg tube was placed and a picc line was placed to deliver a course of antibiotics. While admitted the antibiotics were continued for 7 days and the antiepileptic drugs were titrated. During her admittance, she reportedly suffered from intermittent tachycardia. She also suffered from acute hypoxemic respiratory failure which was believed to be associated with her seizures and the sedation from the antiepileptic drugs. The patient also experienced hematuria which was caused by the placement of a foley catheter. After a few days in the icu, the patient was extubated. A couple of days later, an ultrasound found a small amount of fluid around the generator which appeared to be a seroma. After a week of being admitted the hospital, it was decided that the patient's clinical presentation was more consistent with status epilepticus than an infection. Therefore, the picc line was removed and antibiotics were discontinued. The patient was discharged the following day where she was noted to be medically stable and her white blood cell had returned to normal. She was instructed to continue her antiepileptic drugs and to monitor her heart rate and the fluid collection at the generator site. No additional relevant information has been received to date.

Event Description
It was reported that two days prior to presenting to the hospital in a status epilepticus state the patient had 2 grand mal seizures. Then 24 hours later she had another 2 grand male seizures. The following day she went into a status epilepticus state. Her caregiver attempted to give her a dose of midazolam however it did not stop the seizures. The patient then missed doses antiepileptic medication due to the frequency of the seizures. At a follow-up appointment since being released from the hospital it was noted that the patient was mentally and physically stable. The physician did not know the cause of the status epilepticus event however it was noted that the patient had missed a dose of antiepileptic medication. During the visit it was noted that the vns was functioning.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6064124
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dennis100
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« Reply #64 on: January 03, 2018, 02:15:28 AM »

Model Number 102
Event Date 09/23/2015
Event Type Death
Event Description
During routine follow-up for end-of-service devices, a vns patient was found to be deceased the after the company representative found an online obituary. The obituary provided the patient¿s date of death was (b)(6) 2015, and that she had passed in the hospital. An estimate of battery life with the manufacturer¿s available in-house data estimated the battery had 0. 0 years until near end of service at the time of the patient¿s death. Additional relevant information has not been received to-date.

Event Description
The discharge summary was received by the hospital where the patient expired, and provided the cause of death was severe sepsis secondary to vancomycin resistant enterococci urinary tract infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6173546
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dennis100
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« Reply #65 on: January 05, 2018, 03:49:31 AM »

Device Problem No Known Device Problem
Event Date 08/13/2016
Event Type Injury
Event Description
It was reported via an article received that the patient was diagnosed with a urinary tract infection and sepsis the day following the vns implantation surgery. The patient had a temperature of 101. 4 ºf and low blood pressure requiring boluses of iv fluid. The patient was placed on antibiotics and the fever and blood pressure issues resolved after 4 days. It was stated that the patient's vns was programmed on in the operating room. No additional relevant information has been received to date.

Manufacturer Narrative
Yazdi n, schumaker j. Treatment of refractory status epilepticus with vagus nerve stimulator in an elderly patient. World neurosurgery. November 2016. 95:620. E1-620. E7.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7111449
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dennis100
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« Reply #66 on: January 30, 2018, 02:22:54 AM »

Model Number 102
Event Date 03/28/2009
Event Type Death
Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
It was reported that the vns patient passed away on (b)(6) 2009. Attempts for additional relevant information have been unsuccessful to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2008.

Event Description
The patient¿s cause of death was obtained and listed underlying cause of death as ¿megacolon, not elsewhere classified¿ with record axis of ¿septicemia, unspecified¿, ¿unspecified mental retardation,¿ and ¿other and unspecified convulsions. ¿ with this information, it was determined that the death is unrelated to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3938448
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dennis100
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« Reply #67 on: January 30, 2018, 02:24:17 AM »

Model Number 103
Event Date 01/30/2014
Event Type Death
Event Description
Additional information received revealed that was not related to vns and is being investigated as a homicide.

Event Description
It was reported that the patient passed away from septicemia very suddenly. It was reported that it was unknown whether or not the patient's death was related to vns. The funeral home reported that the device was not explanted by them; however, the patient underwent an autopsy prior to burial and that the device may have been explanted during the autopsy. It is unknown whether or not the patient was buried with the device implanted. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3661594
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dennis100
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« Reply #68 on: March 28, 2018, 02:03:24 AM »

Model
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dennis100
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« Reply #69 on: June 14, 2018, 12:44:19 AM »

Model Number 102
Device Problem Low impedance
Event Date 12/07/2012
Event Type  Death   
Manufacturer Narrative
Evaluation codes; corrected data: the previously submitted mdr inadvertently omitted the new conclusion code per receipt of information relating to cause of death.
 
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 unspecified infantile cerebral palsy, which was contributed by unspecified septicemia, congestive heart failure, unspecified pneumonia, unspecified coma, other and unspecified convulsions, foreign body in respiratory tract (part unspecified), and inhalation and ingestion of other objects causing obstruction of respiratory tract. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
The patient died from pneumonia. There was no indication that the pneumonia was related to vns in any way. The device was buried with the patient, so no analysis could be performed.
 
Event Description
The article "long-term seizure and psychosocial outcomes of vagus nerve stimulation for intractable epilepsy" mentioned that 15 of the vns patients implanted at a certain hospital between 1997 and 2013 that the researchers attempted to contact were found to be deceased. This report will house one of 5 deaths of the known deceased patients that fit the criteria. The patient died on (b)(6) 2012 due to unknown reasons. Programming history suggested low impedance, but there were no patient adverse events to suggest that the death was related to the low impedance in any way. The relationship of the death to vns is unknown. Attempts for further information have been unsuccessful to date. The mfr. Report numbers of the five deaths of known deceased patients are: 1644487-2015-06606, 1644487-2015-06607, 1644487-2015-06608, 1644487-2015-06609, 1644487-2015-06610.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5256308

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dennis100
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« Reply #70 on: June 23, 2018, 12:19:21 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 #71 on: June 23, 2018, 12:20:05 AM »

Model Number 104
Device Problem No Information
Event Date 01/25/2012
Event Type  Death   
Manufacturer Narrative
Date received by manufacturer, corrected data: the g4 received date was inadvertently not provided in follow-up report #02. The received date for follow-up report #02 was 03/03/2016.
 
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient had died on (b)(6) 2012 due to causes of lobar pneumonia, unspecified; septicemia, unspecified; dysphagia; other and unspecified convulsions. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
Reporter indicated a vns patient had died due to pneumonia, but declined to give any additional information. The explanted vns generator and lead have been returned and are pending analysis. Attempts for further information from the treating neurologist are in progress.
 
Manufacturer Narrative

Event Description
Manufacturer follow up with the treating neurologist revealed the death was unrelated to vns. The patient had severe mental retardation, and did have seizure reduction with vns. The patient was hospitalized at the time of death. Per the group home, the patient died from pneumonia. The patient did have a history of cardiac/respiratory problems due to pneumonia. The patient was taking depakote, carbatrol, valium, and rescue diastat at the time of death, and was compliant with taking his medications. Product analysis of the explanted vns generator and lead was completed. Results of diagnostic testing indicated the generator was operating properly. 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. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pins at one point in time. Continuity checks of the returned lead portions 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 portions of the device. The electrode array was not returned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2465321
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dennis100
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« Reply #72 on: June 23, 2018, 12:20:47 AM »

Model Number 102
Event Date 06/25/2007
Event Type  Death   
Event Description
It was reported that the vns patient passed away. The patient's online obituary indicated the patient's date of death and that the patient passed away at the hospital. The cause of death is unknown. The relationship to vns is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
The mortuary reported that there are no records for the patient, so it was unable to be determined whether or not the patient was buried or cremated; however, standard procedure is that patients be buried with devices or explant and discard the device if the patient is cremated. The death certificate is unable to be obtained by the state of death. No additional relevant information has been received to date.
 
Event Description
The cause of death was listed as septicemia, encephalopaty, respiratory failure, cardiac arrest and uspecified renal failure.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4091894
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dennis100
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« Reply #73 on: July 06, 2018, 10:10:16 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 06/03/2018
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient passed away. It was noted the patient had been in and out of the hospital and under a doctor¿s care for issues other than seizures and vns. It was stated that the cause of death was due to traumatic brain injury, sepsis and recurrent urinary tract infections. The patient¿s neurologist was not informed of the patient¿s passing but stated that they saw the patient a few weeks after their generator replacement where the vns settings were adjusted at that time, and the patient had been doing well and was happy with the outcome. There was no indication from the clinic notes of an infection or other surgical issues due to the recent vns surgery at the patient¿s most recent appointment with their neurologist. The patient's device was not removed at the time of burial. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7645125
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dennis100
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« Reply #74 on: August 10, 2018, 03:59:26 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/13/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy but related to the implanting procedure.
 
Event Description
It was stated in a fax from a physician that sepsis was found in an abscess near a patient's vns device after a recent battery replacement and that the device was explanted the next day. Device history records were reviewed for the device and it was indicated that the device was sterilized and passed all quality inspections prior to distribution. No other information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7709602
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dennis100
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« Reply #75 on: October 09, 2018, 01:04:08 PM »

Model Number 103
Event Date 05/03/2012
Event Type  Injury   
Event Description
Follow up with the physician revealed that no additional information was known or could be provided. It is believed that the patient is not currently being treated by a physician with the information received to date, so attempts for additional follow up is not possible thus far.
 
Manufacturer Narrative
Describe event or problem, corrected data:the initial report inadvertently did not report that the physician wanted the device to be disabled so that the patient's device could be explanted.
 
Event Description
The physician requested on (b)(6) 2012 that someone disable the the patient's device as soon as possible inorder for explant to be completed. However the following day when the company representative checked the device, it was already disabled. It is unclear where the infection site was located.
 
Event Description
A physician reported that a vns patient was currently admitted to the icu with diagnosis of septic shock. The patient's device had not been checked for over a year. A company representative traveled to the hospital and reported that the device was disabled. She referred this information to the hospital staff. However, it is believed that there were no treating vns physicians at the hospital. Attempts for additional information have been unsuccessful to date. A review of the patient's generator and lead manufacturer's records was performed and sterility was confirmed prior to distribution.
 
Manufacturer Narrative
Outcomes attributed to adverse event, corrected data:the initial report inadvertently did not include that interventions were taken (as the device was disabled). Type of report, corrected data:the initial emdr inadvertently excluded the checkbox indicating that this is a 30-day report.
 
Manufacturer Narrative
Device manufacturing records 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=2594956
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dennis100
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« Reply #76 on: October 29, 2018, 11:15:01 AM »

Model Number 102
Event Date 06/04/2012
Event Type  Death   
Event Description
On (b)(6) 2012, a vns patient's son reported that the vns patient had recently passed away. The son reported that the death was not related to vns. An online obituary search showed that the patient's date of death was (b)(6) 2012. On (b)(6) 2012, follow up with the funeral home and physician's office was performed. Follow up with the associated funeral home revealed that the device was explanted prior to burial and discarded. It was also stated that the cause of death was cardio-respiratory failure. The physician's office stated that the patient had not been seen for some time. A battery life calculation was performed on (b)(6) 2012 with 9. 18 years to eri=yes. Attempts for additional information have been unsuccessful.
 
Event Description
This death event has been evaluated and with the available information the death has been determined to be possible sudep. Even though the funeral home reported the cause of death was cardiorespiratory failure, this is very vague and ultimately all deaths occur as a result of cardiorespiratory failure in some manner. The circumstances of the death, the general health of the patient, location of the death (inpatient or at home), and if seizures were involved with the death are all still unknown. As such, sudep cannot be ruled out as a possible cause of death.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2012, the patient's death certificate was received. The certificate indicated that the patient passed in a natural manner. The underlying cause was cardiorespiratory failure (few days), septic shock with multi-system organ failure, and chronic liver disease with (b)(6). Follow-up with the patient's physician showed that no information was available regarding the patient. A sudep evaluation was performed with the new information. This death event has been reviewed and with the available information has been determined not to be sudep. Per the death certificate, the cause of death was cardiorespiratory failure, septic shock with multi-organ failure, and chronic liver disease with (b)(6). Although the location of the death is not listed on the death certificate, it is likely the patient died in a hospital setting due to the reported event of septic shock and multi-organ failure. The patient was likely in a poor state of health at the time of death, and the death was likely witnessed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2672168
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dennis100
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« Reply #77 on: December 07, 2018, 10:57:44 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/08/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient had an increase in seizures below pre-vns baseline frequency due to infection. The patient was hospitalized where he was found to be diagnosed with sepsis and tachycardia. The patient was admitted to the icu for several days. Review of the device history record showed that both the lead and generator were sterilized prior to distribution and there were no unresolved non-conformances prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8089667
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« Reply #78 on: December 16, 2018, 04:58:21 AM »

Model Number 102
Event Date 07/28/2012
Event Type  Death   
Event Description
It was reported that the vns patient passed away in 2012. The psychiatrist did not know the cause of death. An online obituary was found which identified the date of death and that the patient passed away in the hospital. The funeral home indicated that the patient was cremated and that the device was explanted and discarded; therefore no analysis can be performed. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description
The death certificate listed the immediate cause of death as septic shock, due to (or as a consequence of) febrile neutropenia, due to (or as a consequence of) diffuse large b-cell lymphoma. The manner of death was listed as natural.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4728389
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« Reply #79 on: December 26, 2018, 12:33:23 PM »

Model Number 101
Event Date 03/23/2013
Event Type  Death   
Manufacturer Narrative
Outcomes attributed to adverse event; corrected data: additional information indicates that the patient¿s death occurred on (b)(6) 2013. Date of event; corrected data: additional information indicates that the patient¿s death occurred on (b)(6) 2013.
 
Manufacturer Narrative

Event Description
It was reported that the patient died a couple of weeks prior. No further details were known at the time of report. Attempts to obtain additional information are underway, but no additional information has been received to date.
 
Event Description
Additional information was received stating that the vns patient passed away in his hospital bed on (b)(6) 2013 due to small bowel obstruction and septic shock. The patient¿s death was not related to vns. An autopsy was not performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3519446
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« Reply #80 on: April 21, 2019, 03:46:49 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/20/2016
Event Type  Death   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported to a company representative that a vns patient passed away on (b)(6) 2016. The patient had a battery replacement on (b)(6) 2016. Initially, the company representative was informed that the patient had died from a seizure and the role of vns in the death was not known at the time. It was stated to her that the patient had issues relating to bradycardia. She died in the hospital, and it was also stated it was suspected the patient was septic after surgery, and that the patient had undergone a separate procedure in the same operation which was unrelated to vns. It was stated the medical professionals are trying to determine the cause of death and have not ruled out the influence of vns, but there are multiple potential causes. An autopsy will not be performed. Additional relevant information has not been received to-date.
 
Event Description
Follow-up to the company representative who attended the replacement surgery provided that the results of diagnostics were within normal limits.
 
Event Description
Follow-up to the treating physician revealed the cause of death was due to multi-organ systemic infection which was not related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6114422
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« Reply #81 on: May 18, 2019, 01:17:37 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2015
Event Type  Death   
Event Description
It was found through obituary search that this patient passed away. Review of the manufacturer's programming history found that the patient's generator had detected high impedance, as is captured in mfr. Report # 1644487-2017-03833. However, no adverse events were known associated with this high impedance event. No further relevant information has been received to date. The suspect product has not been received to date.
 
Event Description
It was reported by the patient's funeral home that the patient passed away due to sepsis from an enterococcus urinary tract infection. The patient's device was buried with the patient. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6577280
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