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Author Topic: Cyberonics Says SUDEP  (Read 1480 times)
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dennis100
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« Reply #30 on: February 24, 2019, 03:34:31 AM »

Model Number 105
Event Date 10/25/2016
Event Type  Death   
Event Description
It was reported that the patient passed away (b)(6) 2016. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. Attempts at information have been made, but no additional relevant information has been received to date.
 
Manufacturer Narrative
Corrected results: no known impedance problem was seen.
 
Event Description
A death certificate was received from the funeral home. Per the death certificate, the patient died of suicide immediately from a gunshot wound to the head. An internal sudep evaluation was performed with this new information by the manufacturer which determined the death to be unlikely sudep. No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6141109
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dennis100
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« Reply #31 on: February 24, 2019, 03:36:00 AM »

Model Number 103
Event Date 01/08/2013
Event Type  Death   
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.
 
Event Description
An explanted generator and lead were received for analysis from another medical device manufacturer. The devices had been inadvertently returned to the wrong manufacturer. It was noted that the vns patient had passed away. It was noted that in the last several weeks the patient had been feeling weak and his breathing had stopped. The patient was unresponsive on arrival. No cause of death or relationship of the death to vns was indicated. It was noted that an autopsy was performed. No additional relevant information has been received to date. Analysis of the devices are underway, but have not been completed to date.
 
Event Description
This death information has been reviewed by the medical device manufacturer and with the available information has been determined to be possible sudep. It is not known what state of health the patient was in, or the manner of death, or the cause of death. The physician's office was unable to provide any information as they had no records on the patient.
 
Event Description
Analysis of the returned generator and lead was completed. An end-of-service (eos) condition was found with pulse generator. There were no performance or any other type of adverse conditions found with the pulse generator. There is no evidence to suggest an anomaly with the returned lead portion. Note that since a large portion of the lead assembly was not returned for analysis, an evaluation cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4167523
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dennis100
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« Reply #32 on: February 24, 2019, 03:36:35 AM »

Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/11/2009
Event Type  Death   
Event Description
It was reported that the patient had passed away. The reporting physician did not know of the cause of death. An online obituary showed the date of death. The servicing funeral home reportedly did not have records of the disposition of the patient¿s vns system. An internal classification has determined that the patient's death may be possible sudep. No additional pertinent information has been received to date.
 
Event Description
The generator and lead device history records were reviewed, and it was found that all specifications were met prior to distribution. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6252760
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dennis100
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« Reply #33 on: February 24, 2019, 05:19:58 AM »

Model Number 103
Event Date 01/09/2012
Event Type  Death   
Event Description
During an in-house device audit call, it was reported by the physician's office that the patient had expired on (b)(6) 2012. The office did not have any record of the vns device(s) being explanted. No additoinal information was provided, and attempts for additional information have been unsuccessful to date. The physician is no longer a practicing at the office.
 
Event Description
This death event has been reviewed by the manufacturer's nurse, and with the available information has been determined to be possible sudep. The patient died and had epilepsy, and also had bladder and prostate cancer but the cause of death is unknown at this time. As such, sudep cannot be ruled out as a possible cause.
 
Event Description
The patient was last seen by the treating vns physician on (b)(6) 2011, and there is no mention of the patient's death in his medical chart. The last note reported that he also had prostate and bladder cancer. The relationship of these events is unknown. No diagnostics were recorded in the chart. Attempts for additional information have been unsuccessful to date. Attempts for the death certificate are in progress, but it has not been received to date.
 
Event Description
The patient's death certificate was received from the state vital records department which reported the cause of death as cardiac arrest, respiratory failure and pneumonia. Other significant conditions contributing to the death but not resulting in the underlying cause was coronary artery disease. No operation was performed for any condition. The date of death was confirmed as (b)(6) 2012. Follow-up was performed on (b)(6) 2013 to the treating hospital facility for additional information regarding the cause of death and the relationship to vns. However, additional information could not be provided without patient spouse/caregiver written consent. This death event was reviewed by the manufacturer's nurse and with the available information has been determined not to be sudep. Per the death certificate, the cause of death was due to cardiac arrest, respiratory failure, and pneumonia. The patient died in the hospital, indicating he was likely not in a reasonable 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=2816451
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dennis100
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« Reply #34 on: February 24, 2019, 01:04:51 PM »

Model Number 102
Event Date 12/23/2011
Event Type  Death   
Manufacturer Narrative

Event Description
On (b)(6) 2011, a funeral home representative reported that the vns patient had passed away and they were going to return the explanted vns device. The representative did not know the cause of death or who the patient's neurologist was. The representative did state that he thinks that the cause of death was natural and knows that "seizure disorder" was written down but was unsure of the exact cause of death. The representative said he would be returning the generator and a portion of the leads as he simply cut the wires. The patient's obituary was found online and it reported that the patient had died unexpectedly at home of natural causes on (b)(6) 2011. According to the vital records department in the state the patient passed away in, the only entities who can obtain a copy of the patient's death certificate are legal representatives of the deceased's estate, immediate family members, extended family members who indicate a direct relationship to the deceased, and those with power of attorney. Since the manufacturer of the patient's medical device is neither of these entities, a copy of the death certificate cannot be attained. The explanted generator and lead were returned for product analysis on (b)(4) 2012 that has not yet been completed. The identity of the patient's neurologist is unknown at this time so no follow up can be made to the physician for further information. The patient's programming history was reviewed. On date of implant, (b)(6) 2006, a faulted system diagnostics test changed the patient to test settings of output=1ma/frequency=20hz/pulse width=500usec/on time=30sec/off time=60min/magnet output=1ma/magnet output=500usec/magnet on time=30sec; however, the patient was interrogated afterwards and the settings in question were noticed and the patient was programmed back off to output=0ma/frequency=20hz/pulse width=500usec/on time=30sec/off time=60sec/magnet output=0ma/magnet pulse width=500usec/magnet on time=30sec since it was the date of implant. The patient was last programmed to output= 2ma/frequency=15hz/pulse, width=130usec/on, time=30sec/off time=0. 8min/magnet, output=2. 25ma/magnet, pulse width=500usec/on, time=60sec on (b)(6) 2010. A system diagnostics performed on (b)(6) 2010 showed the device to be functioning properly with output=ok/lead impedance=ok/dcdc=2/eri=no. A battery life calculation was performed with the programming history available which showed negative years until elective replacement indicator (eri) =yes.
 
Event Description
Additional information was received on february 2, 2012 when product analysis was completed on the explanted lead. A portion of the lead, including the electrode array was not returned for analysis, therefore an evaluation and resulting commentary cannot be made on that portion of the lead. Except for an abraded opening in the outer tubing, there were no observed product related issues with the returned lead portions. The lead assembly has remnants of what appear to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other the end of the returned lead portion. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis on the generator was completed on february 16, 2012. The device 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. However, the elective replacement indicator (eri) was set. The battery was partially depleted and determined to be the result of normal expected battery consumption based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of possible 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=2422901
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dennis100
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« Reply #35 on: February 25, 2019, 01:27:53 AM »

Model Number 103
Device Problem Insufficient Information
Event Date 06/04/2011
Event Type  Death   
Event Description
Additional information was received on (b)(6) 2012, when the physician's nurse reported that the patient's cause of death is unknown but was unrelated to vns. The patient's concurrent illnesses or diseases were noted to be post-traumatic epilepsy, fracture of subdural hematoma (1999), history of nonconvulsive status epilepticus. The patient had continued seizures with vns therapy. The patient was still receiving vns therapy at the last office visit; output=1ma/frequency=25hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=1. 25ma/magnet on time=60sec/magnet pulse width=250usec. The patient was noted to have passed away on (b)(6) 2011. It was unknown if the vns was explanted after the patient's death. They did not have any recent laboratory reports or findings considered relevant to the cause of death. No death certificate was provided. It was unknown if the patient's death was witnessed. The patient was (b)(6) upon epilepsy onset. The patient did not have a history of febrile seizures. The patient had second generalized seizures and complex partial seizures. The patient has never undergone resective epilepsy surgery. At the time of death (by phone report on (b)(6) 2011), the patient was taking keppra, dilantin, phenobarbital, keonopinic, and tegrete and the patient was noted to be compliant with aeds. The patient's obituary was found online which stated that the patient's date of death was (b)(6) 2011. The patient's death was determined to be a possible sudep with the information received to date.
 
Manufacturer Narrative

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 "other and unspecified convulsions," respiratory failure (unspecified). A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of possible sudep. There is no allegation or other information indicating that the death is related to vns.
 
Manufacturer Narrative
Type of reportable event: initial report inadvertently listed the type of reportable event as a serious injury instead of a death.
 
Event Description
On (b)(6), 2012 it was reported that the vns patient passed away last year. No further information was provided at the time. Currently there is not enough information to rule out sudp as a possible cause of death, therefore the death is concluded possible sudep at this time. Good faith attempts for further information from the physician's nurse have been made but have been unsuccessful. A copy of the patient's death certificate cannot be obtained as the manufacturer does not meet the eligibility requirements of who is allowed to obtain a copy of a patient's death certificate in the state the patient passed away in.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2742866
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dennis100
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« Reply #36 on: February 25, 2019, 01:28:35 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/04/2014
Event Type  Death   
Event Description
It was found via search that the patient passed away. Per neurologist's office, patient was last seen on (b)(6) 2014 and the patient's sister had called to report about patient's death. No additional relevant information has been received. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep.
 
Event Description
Additional information was received from the neurologist's office that the patient was found dead on the bathroom floor. Autopsy was performed but the results were unknown. The neurologist presumed the death to be sudep related. The patient did pass away suddenly or unexpectedly. The death was not believed to be related to vns therapy. The neurologist's office reported the believed cause of death as sudep. The believed relationship between vns and cause of death is unrelated.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6415530
« Last Edit: May 05, 2019, 12:10:26 AM by dennis100 » Logged
dennis100
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« Reply #37 on: February 25, 2019, 08:11:15 AM »

Model Number 103
Event Date 05/07/2016
Event Type  Death   
Event Description
A provider reported that a vns patient expired from an unknown cause and was found late on the evening of (b)(6) 2016 and apparently had been dead for a week. The provider stated she had no further information to provide regarding the cause of death. Follow up with the medical examiner indicated they the official date of death was recorded as (b)(6) 2016. The medical examiner stated that no further information of any kind, such as cause of death or funeral home information, could be released without a signed release from the immediate next of kin. Follow up with healthcare provider indicated they were informed of the patient's death by a local policeman who indicated that life saving measures were attempted but were unsuccessful as it appeared the patient had been dead approximately a week. The provider indicated the possibility of sudep was increased in this patient due to a history of myoclonic and generalized seizures, medically resistant generalized epilepsy with cognitive impairment. The patient did not have a history of resective surgery and age of onset of seizures was (b)(6) from an unknown reason. Vns settings at the most recent visit were typical for vns patients with device diagnostics within normal limits. It was reported that the patient experienced seizure reduction with vns therapy. The provider was unsure of the relation of the death to vns therapy. An internal sudep analysis indicates that the death was possibly related to sudep.
 
Manufacturer Narrative
The manufacturer's initial mdr inadvertently did not include this information.
 
Event Description
Review of available programming and diagnostic history revealed no anomalies and a battery life calculation performed with available data indicates the device had 4. 5 years remaining until neos = yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5694647

« Last Edit: April 09, 2019, 12:08:28 AM by dennis100 » Logged
dennis100
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« Reply #38 on: February 26, 2019, 01:28:09 AM »

Model Number 103
Device Problem Insufficient Information
Event Date 10/10/2011
Event Type  Death   
Manufacturer Narrative
Outcomes attributed to adverse event, corrected data: the initial report inadvertently reported the incorrect date. Date of event, corrected data: the initial report inadvertently reported the incorrect date.
 
Manufacturer Narrative

Event Description
It was reported that the patient was found dead in the bathroom over the weekend. The cause of death is unknown at this time. The physician did not state or definitely rule out the relationship between patient's death and vns. Sudep cannot be ruled out due to insufficient evidence regarding the circumstances of the death. It is unknown if an autopsy was performed at this time. Attempts for further information have been unsuccessful to date.
 
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) 2011 and the patient's cause of death was "other and unspecified convulsions. " a sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of potential 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=2337718
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dennis100
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« Reply #39 on: February 27, 2019, 07:35:27 AM »

Model Number 101
Event Date 05/19/2015
Event Type  Death 
Manufacturer Narrative
 
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 cancer. The patient¿s device was not explanted; therefore, no analysis can be performed. Attempts for additional relevant information have been unsuccessful 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.  .

Event Description
The explanted generator and lead were received on (b)(4) 2016. Analysis was completed for the lead. Scanning electron microscopy images of the unmarked connector pin show appearance suggesting that pitting or electro-etching conditions have occurred on the pin surface. The exact reason for this condition is unknown. Since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. In the pa lab, 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. Analysis of the device in the pa lab found that the eri flag was set. An open can measurement of the battery voltage confirmed that the eri flag had been properly set; the device was operating at low battery voltage. The low battery condition (depleted) was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The pa lab concluded proper functionality of the generator and that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4871280
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« Reply #40 on: March 07, 2019, 01:05:37 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2012
Event Type  Death   
Manufacturer Narrative

Event Description
The manufacturer performed a sudep evaluation and based on the information available, the death was determined to be possible sudep.
 
Event Description
On (b)(6) 2012 a vns treating neurologist reported that the vns patient had passed away. No additional information about the cause of death or date of death was provided at that time. The patient's obituary was found online which reported that the date of death was (b)(6) 2012. The obituary further stated that the patient died that morning at a hospice after an extended illness. The patient's neurologist reported that the patient was seen by them on (b)(6) 2010 only and they do not have the patient's cause of death or any further information. The death certificate for the patient was requested from the office of vital records in the state the patient passed away in; however, the office representative stated that the manufacturer of the patient's implanted vns is not eligible to obtain a copy of the patient's death certificate.
 
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 due to multiple myeloma. 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=2844921
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dennis100
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« Reply #41 on: March 10, 2019, 01:47:49 AM »

Model Number 103
Event Date 08/29/2015
Event Type  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. Based on the limited available information about the patient's death, an internal classification has determined that the death may be possible sudep. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2014. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5101244
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dennis100
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« Reply #42 on: March 11, 2019, 07:06:46 AM »

Model Number 102
Event Date 08/16/2015
Event Type  Death   
Event Description
It was reported that the vns patient passed away. The cause of death is unknown. The relationship of the death to vns is unknown. Attempts to obtain additional relevant information have been unsuccessful 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5086253
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« Reply #43 on: March 13, 2019, 12:05:44 AM »

Model Number 106
Event Date 10/07/2015
Event Type  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. Attempts for additional relevant information have been unsuccessful 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
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5194056
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dennis100
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« Reply #44 on: March 14, 2019, 03:43:46 AM »

Model Number 101
Event Date 10/24/2016
Event Type  Death   
Event Description
It was reported that the patient passed away the week of (b)(6) 2016. The patient's vns had died and was no longer delivering stimulation at the time of death. On (b)(6) 2016, the patient's caretaker said the patient was on life support and didn't know if the patient would be able to handle any surgery. Per a manual battery life calculation, it is likely the reports that the device was not working at the time of death were correct. Per a sudep evaluation, this patient experienced possible sudep attempts to find an online obituary for the deceased were made, but no relevant information has been found to date. No additional relevant information has been received to date. The generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6119312
« Last Edit: April 21, 2019, 03:09:07 AM by dennis100 » Logged
dennis100
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« Reply #45 on: March 14, 2019, 03:44:22 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/07/2013
Event Type  Death   
Event Description
It was found that the patient passed away per the obituary search. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. Additional relevant information has not been received to date.
 
Event Description
Death certificate was received with the cause of death listed as "respiratory insufficiency" due to "apneas with associated laryngospasm". The patient's respiratory insufficiency lasted 4 days and apneas with associated laryngospasm were present for 2 years. An internal sudep evaluation was performed by the manufacturer which determined the death to be unlikely sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6412107
« Last Edit: May 05, 2019, 12:12:26 AM by dennis100 » Logged
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« Reply #46 on: March 16, 2019, 12:04:41 AM »

Model Number 101
Event Date 01/22/2013
Event Type  Death   
Event Description
It was reported that a vns patient passed away. Cause of death and any possible relationship to vns therapy is unknown. The funeral home was able to provide information that the patient died of natural causes, but could not provide the cause of death. Based on the limited available information about the patient's death, an internal classification has determined that the death may be possible sudep. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5128311
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« Reply #47 on: March 26, 2019, 01:12:41 AM »

Model Number 102
Event Date 01/12/2014
Event Type  Death   
Event Description
It was reported that the vns patient passed away on (b)(6) 2014. The cause of death and its relationship to vns are unknown. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013. A battery life calculation using the available programming history showed approximately 1. 6 years remaining as of (b)(6) 2013. Follow-up with the funeral home revealed that the patient was buried with the device; therefore, no analysis can be performed. Attempts for additional relevant information have been unsuccessful 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5358720
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dennis100
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« Reply #48 on: March 26, 2019, 01:13:27 AM »

Model Number 102
Event Date 11/22/2015
Event Type  Death   
Event Description
It was reported that the patient passed away on (b)(6) 2015. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. A death certificate could not be requested as the death records are strictly confidential until 50 years after the year of death per state law. Attempts for additional relevant information were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5358980
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« Reply #49 on: March 26, 2019, 01:14:07 AM »

Model Number 102
Event Date 11/22/2014
Event Type  Death   
Event Description
It was reported that the patient passed away on (b)(6) 2014. Patient was reported to be in a hospice due to an unknown reason. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. The patient's death certificate was not requested as they do not contain the cause of death per state law. Attempts for additional relevant information and product return were made but were unsuccessful. A battery life calculation for the patient's generator with the available data shows that the patient had approximately 0 years remaining until neos = yes at the time of death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5363154
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« Reply #50 on: March 30, 2019, 01:08:03 AM »

Model Number 102R
Event Date 12/03/2008
Event Type  Death   
Event Description
It was reported that the patient passed away on (b)(6) 2008 but the cause of death is unknown. The death certificate was unable to be obtained. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. Attempts were made for additional relevant information but it has not been received to date.
 
Manufacturer Narrative
Brand name, corrected data: pulse gen model 102r. Model #, corrected data: 102r. Serial #, corrected data: (b)(4). Lot #, corrected data: 015484. Expiration date (ma/day/yr) corrected data: 03/31/2008. If implanted, give date (mo/day/yr), corrected data: (b)(6) 2006. Device manufacture date (mo/day/yr),corrected data: 05/23/2006. Initial mdr inadvertently listed the wrong product information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5518747
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dennis100
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« Reply #51 on: March 30, 2019, 01:08:50 AM »

Model Number 102
Event Date 06/05/2013
Event Type  Death   
Event Description
It was reported that the patient passed away but the cause of death is unknown. Per the state law, access to death records is restricted for 50 years after the date of the event. Therefore the death certificate could not be obtained. The patient's neurologist was unable to provide any details regarding the cause of death and mentioned that the office haven't seen the patient in a long time. Attempts for additional relevant information to the assisted living facility, where the patient resided, were unsuccessful. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5514073
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dennis100
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« Reply #52 on: March 31, 2019, 06:37:49 AM »

Model Number 103
Event Date 02/05/2016
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient had passed away. The cause of death is unknown. The relation of the patient's death to vns is unknown. A death certificate or autopsy report for the patient could not be obtained. The funeral home for the patient is unknown. Based on the limited available information about the patient's death, an internal classification has determined that the death may be possible sudep. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5490239
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dennis100
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« Reply #53 on: March 31, 2019, 06:38:20 AM »

Model Number 103
Event Type  Death   
Event Description
It was reported that the patient passed away but the cause of death is unknown. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. Attempts were made for additional relevant information but it has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5518844
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dennis100
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« Reply #54 on: March 31, 2019, 06:38:55 AM »

Model Number 102R
Event Date 05/10/2015
Event Type  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. Attempts for additional information have been unsuccessful 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5484640
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dennis100
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« Reply #55 on: April 01, 2019, 12:14:58 AM »

Model Number 106
Event Date 05/01/2016
Event Type  Death   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient implanted with a vns device had passed away on (b)(6) 2016. The cause of death has not been provided. Attempts for additional information have been made without success to date. The death has been determined as possible sudep based on the manufacturer's review of the available information due to the cause of death being unknown.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5679103
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dennis100
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« Reply #56 on: April 02, 2019, 12:06:57 AM »

Model Number 106
Event Date 04/23/2016
Event Type  Death   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had passed away. The cause of death is unknown. A search for an obituary determined the date of death. The patient's vns system was reportedly explanted post-mortem, but was not available for return. Based on the limited available information about the patient's death to the manufacturer, an internal classification has determined that the death may be possible sudep. However, the patient's death is suspected to be sudep by the involved medical professionals based on circumstances unknown to the manufacturer. The conclusion of their assessment has not been conveyed to date.
 
Event Description
The explanted generator and lead were received by the manufacturer on (b)(6) 2016 for product analysis. Product analysis was completed on the returned lead portion on (b)(6) 2016. A section of the lead assembly was returned for analysis in one piece with the lead connector portion still attached to the pulse generator. Initial testing on the generator as-received showed the lead pin had electrical continuity with the generator. The lead's electrodes were not returned for evaluation. Other than the typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis was completed on the returned generator on (b)(6) 2016. Visual examination showed only explant-related observations; no surface abnormalities were noted on this device. The device output signal was monitored for more than 24-hrs 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. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 3. 030 volts during the relevant portion of the final electrical test and showed an ifi=no condition. There were no performance or any other type of adverse condition found with the pulse generator.
 
Event Description
The patient's mother reported that the vns messed up the patient¿s throat to where they could not swallow and struggled to breath. By the time these harmful effects were found, it was too late to save the patient. Additional information was received from the neurologist that the patient had catastrophic neurological disorder that couldn't be characterized. Soon before the patient¿s passing, the patient presented with fever, coughing, difficulty swallowing, as well as an undefined genetic disorder, but there was said to be no relation to the vns device. The patient was seen by a nutritionist around the same time who noticed the patient coughing and gagging, and recommended that the patient should not eat anything by mouth, and therefore the patient was started using tube feeds. A gastrostomy tube was placed about a month prior to the patient's passing. The neurologist mentioned that the vns was working correctly the last time he saw the patient. The doctor does not believe there to have been any malfunction with the vns device. He also stated that the patient had swallowing difficulty since birth and does not believe the swallowing issues or difficulty breathing issues to be due to the vns device, as the patient never presented with these issues in relation to the device. The doctor stated that it was noted that the patient passed away in her sleep. The doctor stated he did not know for sure, but did not believe that the patient's passing was related to the vns device. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5670049
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dennis100
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« Reply #57 on: April 03, 2019, 12:24:12 AM »

Model Number 102
Event Date 03/17/2016
Event Type  Death   
Event Description
It was reported that the patient passed away. The patient's obituary was found online which listed the date of death as (b)(6) 2016. Good faith attempts for further information from the physician were unsuccessful. An internal sudden unexplained death in epilepsy (sudep) evaluation was performed which determined the patient's death to be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5628973
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dennis100
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« Reply #58 on: April 03, 2019, 12:24:48 AM »

Model Number 102R
Event Date 12/19/2013
Event Type  Death   
Event Description
It was reported that the patient passed away. Additional relevant information regarding the patient's death was not provided. An obituary stated that the patient passed away on (b)(6) 2013. A copy of the death certificate could not be requested as only the immediate family members are eligible to request a copy. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. Additional attempts for relevant information were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5760111
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dennis100
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« Reply #59 on: April 04, 2019, 12:34:02 AM »

Model Number 102
Event Date 03/30/2016
Event Type  Death   
Event Description
It was reported that the patient had passed away. This was discovered in an attempt to contact the patient, in which search results yielded a patient obituary showing the date of death. The county coroner was able to verify the date of death, but was not able to give further information as the patient was not in their jurisdiction. Based on the limited available information about the patient's death, an internal classification has determined that the death may be possible sudep. Attempts for additional pertinent information have been unsuccessful to date.
 
Event Description
Follow up with the treating physician's office indicated that the patient's death was unrelated to vns or his epilepsy condition. It was stated to be due to other health problems. Device settings and diagnostics were also reported and were within normal limits at the last known appointment. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5732252
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