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Author Topic: Cyberonics Says SUDEP  (Read 2211 times)
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dennis100
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« Reply #60 on: April 05, 2019, 12:48:04 AM »

Model Number 103
Event Date 05/18/2016
Event Type  Death   
Event Description
It was reported that the patient had passed away. She reportedly had a witnessed seizure in her office, fell and hit her head, and died shortly after. 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 physician's office determined that the patient's last visit was on (b)(6) 2016. The patient's output current was increased from 1. 5 to 1. 75 ma and magnet output from 1. 75 to 2 ma. No more information on settings at that time was available. There was no recent information present that could speak to the device diagnostics or battery status at that time. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5718909
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dennis100
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« Reply #61 on: April 05, 2019, 12:48:52 AM »

Model Number 106
Event Date 05/14/2016
Event Type  Death   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had passed away. In the initial report, it was reported that she was found sitting on the toilet. It was also reported that the patient was non-compliant with medications and had missed 3-4 follow up appointments since the initial vns dosing, and it was likely that her settings were not at therapeutic levels. Additional information received from the autopsy facility indicated that it could not find an obvious cause of death, but the report was not finalized. The available programming history available for the patient¿s generator showed the last available device diagnostics were within normal limits. Additionally, the internal device data showed that the last ">25%" change in impedance occurred post-mortem where it was within normal limits before the change. Although an exactly value of impedance at time of death could not be determined, it was likely within normal limits. Review of the internal tachycardia detection log showed that the last entry was on (b)(6) 2016, when the device was likely being manipulated external from the patient. The previous entry was on (b)(6) 2016, estimated occurrence at 09:04:11. The patient's lead and generator were received by the manufacturer on 06/02/2016 and are undergoing product analysis. Information from the treating neurologist stated that she believed the patient¿s death was not related to vns. She confirmed the patient was not compliant with medications and was likely not taking any antiepileptic drugs at the time of death. The patient had a history of weekly simple partial seizures, complex partial seizures, and generalized seizures. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be probable sudep. No additional pertinent information has been received to date.
 
Event Description
Product analysis was completed on the returned lead portion on 06/24/2016. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No anomalies were noted. Continuity checks of the returned lead portion were performed and no discontinuities were identified. There is no evidence to suggest an anomaly with the returned portion of the device. Note that a large portion of the lead body, including the electrodes, was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Product analysis for the returned generator was completed on 06/28/2016. The internal device data was downloaded and showed no anomalies. Visual examination showed only observations consistent with the device explant procedure. No visual abnormalities were noted. 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 for the entire monitoring period. Both interrogations and system diagnostic tests were performed. 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. There were no performance or any other type of adverse condition found with the pulse generator.
 
Event Description
The patient's autopsy report from the servicing hospital was received by the manufacturer. Post-mortem gross and microscopic examination revealed no significant pathologic abnormalities in any organs to be possibly associated with an immediate cause of death. Based on the clinical history and lack of any identifiable significant lesion on post-mortem examination, the patient's death was ruled as likely being related to her epilepsy and/or its complications. However, a definitive assessment could not be made with certainty. Based on the available information about the patient's death, an internal classification has determined that the death may be probable sudep. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5721814
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dennis100
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« Reply #62 on: April 08, 2019, 01:59:28 AM »

Model Number 102
Event Date 10/12/2008
Event Type  Death   
Event Description
It was reported that the patient had passed away. An online obituary search determined the date of death to be (b)(6) 2008. A review of available programming history for the patient showed that the most recent available history was dated (b)(6) 2008, approximately 2 weeks prior to the patient's death. The device settings were in therapeutic ranges and the device diagnostics were within normal limits. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5699982&pc=LYJ
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dennis100
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« Reply #63 on: April 09, 2019, 12:09:23 AM »

Model Number 102
Event Date 06/04/2009
Event Type  Death   
Event Description
It was initially reported that the patient past away a long time ago. It is unclear is the death was related to vns. There was no further information that was provided as the physician deleted her file and she was no longer in their system. The physician was not willing to give any additional information. Based on the information the patient's death may be a possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2382637
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dennis100
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« Reply #64 on: April 12, 2019, 12:19:40 AM »

Model Number 103
Event Date 10/19/2015
Event Type  Death   
Event Description
It was reported that the patient was deceased. The physician's office did not have a date or cause of death. An internet search found patient's obituary, where the date of death was mentioned. Follow up with the patient's neurologist determined that the patient was last seen on (b)(6) 2016. System diagnostics were reported to be within normal limits, and the last settings were known. The battery status was not explicitly documented, but based on the known documentation practices, the medical professional concluded that an ok battery status was observed since the notes did not directly address it. Follow up with the servicing funeral home showed that the patient was embalmed with no autopsy performed. No evidence was found suggesting the patient's vns system was explanted prior to burial. No information could be given regarding the cause of the patient's death. 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=5774352
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dennis100
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« Reply #65 on: April 14, 2019, 12:50:55 AM »

Model Number 106
Event Date 07/20/2016
Event Type  Death   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a vns patient had passed away. No cause of death has been provided to date. Per the manufacturer's internal sudep evaluation, the death has been determined to be possible sudep. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5880425
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dennis100
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« Reply #66 on: April 15, 2019, 12:09:04 AM »

Model Number 102
Event Date 01/25/2011
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported by a neurologist that a vns patient passed away on (b)(6) 2011 while he was in jail. The patient's death was not related to vns per the treating neurologist and onsite nurse. The emergency room discharge report was received and the report indicated that patient died due to cardiac arrest. Patient was found supine in a hospital bed. Nursing staff stated that he had seized 15 minutes prior to arrival of ems and then went unresponsive. The patient has a history of seizures and has coded in the past after his seizures. Patient was found to be pulse v-tach and cpr was started. Cardiopulmonary resuscitation was performed but was unsuccessful. Patient was pronounced dead at the hospital on (b)(6) 2011. 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) 2011 due to causes of "other and unspecified convulsions". A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of probable sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5984297
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dennis100
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« Reply #67 on: April 16, 2019, 12:05:44 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/02/2014
Event Type  Death   
Event Description
It was reported from the patient's care facility that patient had passed away on (b)(6) 2014. No further information was known at the time of the report. 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
It was reported that the patient was transferred from a rehabilitation care center to a nursing home prior to his death. The discharge was approximately two weeks before the patient¿s death. No additional pertinent information has been received to date.
 
Event Description
The notes summary of the patient¿s care facility around the time of his death was received. Prior to his death, the patient was agitated and combative with staff, refusing full assessment and treatment. Approximately 4 hours later, the next entry shows that the patient was found unresponsive on his back, and had no pulse but was warm to the touch. The patient was thereafter declared dead. No information on cause of death was apparent from the notes. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5975998
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dennis100
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« Reply #68 on: April 17, 2019, 06:33:34 AM »

Model Number 102R
Event Date 07/12/2016
Event Type  Death   
Event Description
It was reported that the patient had passed away. This was identified from an online obituary search. The cause of death is unknown. The last known treating neurologist had not seen the patient since 2014. Follow up with the servicing funeral home could not identify records relating to the patient's device. An internal sudep evaluation with the limited information available information concluded that the patient's death was possible sudep. No additional pertinent information has been received to date.
 
Event Description
The patient's generator and lead were received by the manufacturer for product analysis. No additional pertinent information has been received to date.
 
Event Description
Product analysis on the returned generator was completed. Visual examination showed observations consistent with the surgical procedure; no surface abnormalities were noted on the device. The generator did not communicate as-received, and an open can measurement of the battery voltage determined that the battery was depleted. Based on the electrical test results, the device exhibited current consumption rates that were within specification, indicating that normal battery depletion led to an expected end of service. After the generator can was opened, a visual examination of the pcb performed and revealed no visual anomaly. The device performed according to functional specifications. No abnormal performance or any other type of adverse condition was found with the generator. Product analysis was completed on the returned lead portions. Note that the lead body including the electrodes was not returned for analysis, so a complete evaluation could not be performed on the entire lead. The returned lead portions were consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that a good mechanical and electrical connection was present at least one point in time. Continuity checks of the returned lead portions were performed, and no discontinuities were identified. There is no evidence to suggest an anomaly with the returned portions of the lead. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5958976
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dennis100
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« Reply #69 on: April 17, 2019, 06:34:57 AM »

Model Number 102
Event Date 07/07/2016
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient passed away on (b)(6) 2016. This was identified from an online obituary that a company representative discovered. No information was available on 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 pertinent information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5956408
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dennis100
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« Reply #70 on: April 21, 2019, 03:07:34 AM »

Model Number 105
Event Date 02/17/2016
Event Type  Death   
Event Description
It was reported that the passed away on (b)(6) 2016 from unknown causes. The physician stated that patient was severely mentally impaired and had many comorbidities. The physician's office last saw patient on (b)(6) 2015 and no additional relevant information was provided. Additional information was received from the funeral home that the patient passed away at home and that device was not removed. Per death certificate, the manner of death was natural and the cause of death is seizure disorder. An internal sudep evaluation was performed by the manufacturer which determined the death to be probable sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6096337
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dennis100
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« Reply #71 on: April 21, 2019, 03:10:01 AM »

Model Number 103
Event Date 09/10/2015
Event Type  Death   
Event Description
It was reported that the patient died due to cardiac/circulatory arrest on (b)(6) 2015. Additional information was received from the neurologist that the patient was receiving vns therapy treatment at the time of death. Patient response to vns therapy was seizure reduction. The neurologist did not know the cause of death but indicated that the patient was found unresponsive in asystole (in bed) at 6:30 am with dried vomit. The believed relationship between the vns system and cause of death was reported to be "probably not related". Patient had epilepsy since childhood and experienced 2nd generalized (5-6 per day) and infantile spasms. Patient did not undergo respective epilepsy surgery. Patient does not have a history of drug or alcohol abuse or cardiac or respiratory problems. Patient was taking antiepileptic drugs and was compliant. Patient's death certificate could not be obtained as it is only available to those who have a personal or property right interest with the decedent. It was reported by the funeral home that the patient was cremated and that they do not have any of patient's devices. 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=5174551
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dennis100
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« Reply #72 on: April 22, 2019, 12:14:43 AM »

Event Type  Death   
Event Description
An article title "socioeconomic evaluation of vagus stimulation:a controlled national study" was received by the manufacturer and reviewed. The death of a vns patient is reported. No information is provided regarding the cause of the death. Patient information and implant information are not specified. Attempts to get further information were unsuccessful. Sudep evaluation performed by the manufacturer classified the death as possible supep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6078521
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dennis100
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« Reply #73 on: April 24, 2019, 12:15:41 AM »

Model Number 102
Event Date 06/25/2016
Event Type  Death   
Event Description
It was reported that the patient had passed away on (b)(6) 2016 as identified through a patient obituary identified by a company representative. Follow up with the servicing funeral home showed that the patient¿s vns system was likely not explanted prior to burial; product return is not expected. Communications with the facility caring for the patient at the time of death confirmed the date of death. However, no other pertinent information could be obtained. 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=6179262
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dennis100
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« Reply #74 on: April 26, 2019, 06:03:26 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/21/2015
Event Type  Death   
Event Description
It was reported that the patient passed away. An online obituary showed that the patient died of complications of a seizure. No other information relating the causes or circumstances of death was present. The servicing funeral home did not have record on the disposition of the patient¿s vns system. Follow up with the office of the treating physician showed partial settings from the patient¿s generator. No other relevant information was obtained. Based on the limited available information about the patient¿s death, an internal classification determined that the death may be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6251438
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dennis100
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« Reply #75 on: April 29, 2019, 05:07:01 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/28/2013
Event Type  Death   
Event Description
Patient's explanted devices were returned by a funeral home. It was found via online obituary search that the patient passed away. Analysis is underway but has not been completed to date. No additional relevant information has been received to date. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep.
 
Event Description
A large portion 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. No obvious anomalies were noted except the set of setscrew marks observed near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional 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, and no discontinuities were identified. Based on the findings in the lab, there is no evidence to suggest an anomaly with the returned portion of the device. During the bench interrogation (with a distance of one and a quarter inches (spacer block) between the pulse generator and the programming wand) the pulsedisabled and eos warnings were set. With the pulse generator case removed and the battery still attached to the pcba, the battery voltage indicated an eos condition. The postburn electrical test results show that the pcba performs according to functional specifications. The electrical performance of the generator, as measured in the pa lab, will be used to conclude that no anomalies exist and the end-of-service (eos) condition is an expected event. The were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6358419
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dennis100
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« Reply #76 on: April 29, 2019, 05:07:43 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/14/2014
Event Type  Death   
Event Description
It was found via online obituary search that this vns patient passed away. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. Additional relevant information has not been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6367269
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dennis100
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« Reply #77 on: May 01, 2019, 12:06:10 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Death   
Event Description
Information was received from the physician indicating that the patient passed away (b)(6) 2016. The patient had respiratory issues earlier on the day of death and passed away later in their sleep. A battery life calculation was performed and indicated that 0. 1 year were remaining on the patient's generator as of 06/01/2016. The last known diagnostics were within normal limits. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6322386
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dennis100
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« Reply #78 on: May 03, 2019, 12:28:58 AM »

Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/12/2014
Event Type  Death   
Event Description
An obituary for the patient was found and indicated that the patient had passed away unexpectedly in 2014. The cause of death has not been obtained to date. No autopsy was performed. The funeral home who saw the patient after he passed indicated that no devices were removed from the patient prior to burial. The most recent diagnostics as of (b)(6) 2010 indicate that the patient's generator was functioning properly. A battery life calculation was performed with the available information and indicated that the patient's generator had approximately 1. 7 years remaining from (b)(6) 2009. Based on the battery life remaining, it is suspected that the generator may have reach end of service prior to the patient's death. An internal sudep evaluation was performed by the manufacturer which determined the death to be probable sudep. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6440670
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dennis100
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« Reply #79 on: May 03, 2019, 12:29:42 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/02/2016
Event Type  Death   
Event Description
It was found through an obituary search that the patient passed away at home. Per the patient's neurologist, the patient was last seen in (b)(6) 2016. The cause of death is unknown. Patient's response to vns therapy was seizure reduction. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep.
 
Event Description
Per death certificate, the cause of death is listed as cardiorespiratory arrest. Patient was buried and so the device was likely buried with patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6437415
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« Reply #80 on: May 03, 2019, 12:30:29 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/05/2009
Event Type  Death   
Event Description
The patient was reported to have passed away per an online obituary. Additional relevant information regarding the cause of death has not been received. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep.
 
Event Description
Death certificate was received indicating that the patient's immediate cause of death was due to asystolic cardiac arrest due to respiratory arrest and airway tracheotomy obstruction. The underlying cause of death is chronic respiratory failure. An autopsy was not performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6437633
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« Reply #81 on: May 03, 2019, 12:31:14 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/18/2016
Event Type  Death   
Event Description
The medical examiner's office called to ask about returning the explanted device of the deceased patient. The cause of death is anoxic encephalopathy, drowning, seizure disorder, and blunt head trauma. The explanted devices have not been received to date. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep.
 
Manufacturer Narrative
Device available for evaluation?, corrected data: yes. If yes, returned to manufacturer on (mo/day/yr): 03/24/2017. Initial mdr inadvertently provided incorrect information that the device was not available for evaluation. (b)(4).
 
Event Description
The explanted devices were received. In the lab, 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. The device performed according to functional specifications of the current automated final test. Analysis in the lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Analysis on the lead has not been completed to date.
 
Event Description
An analysis was performed on the returned lead portion. A large portion 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. No obvious anomalies were noted. 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, and no discontinuities were 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6437699
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« Reply #82 on: May 03, 2019, 12:31:51 AM »

Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/20/2011
Event Type  Death   
Event Description
The patient was reported to have passed away per an online obituary. Additional relevant information regarding the cause of death has not been received. 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=6437720
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« Reply #83 on: May 05, 2019, 12:13:29 AM »

Model Number 101
Event Date 10/31/2007
Event Type  Death   
Event Description
On (b)(6) 2015, a death certificate was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2007 and the patient¿s cause of death was cardiopulmonary arrest due to (or as a consequence of) hypoxia due to (or as a consequence of) seizure disorder (grand mal). The death was sudden, within minutes, and the death certificate indicates that no autopsy was performed. The place of death is documented as "own home. " a sudep (sudden unexpected death in epilepsy) evaluation was performed by the manufacturer and it was determined that the death was classified as probable sudep, although there is no information indicating that the death is related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4646199
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« Reply #84 on: May 05, 2019, 12:14:06 AM »

Model Number 102
Event Date 03/19/2014
Event Type  Death   
Event Description
It was reported that the patient passed away on (b)(6) 2014. An internal sudep evaluation was performed by the manufacturer which determined the death to be a possible sudep. The patient's physician did not know the cause of death. In the state the patient passed away in, death certificates are not able to be obtained by the manufacturer of the patient's medical device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5159391
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« Reply #85 on: May 06, 2019, 02:59:14 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/28/2012
Event Type  Death   
Event Description
It was found that the patient passed away per the obituary search. A battery life calculation was performed with the available data and the results showed that the device had 0. 8 years remaining until eri = yes as of 11/28/2012. Therefore the device was likely functioning at the time of the patient's death. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6402811
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dennis100
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« Reply #86 on: May 06, 2019, 02:59:48 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/18/2016
Event Type  Death   
Event Description
It was found that the patient passed away at home from an obituary search. Per the neurologist, the patient's cause of death was cardiac arrhythmia due to seizure disorder. The patient did pass away suddenly or unexpectedly. Patient response to vns therapy was seizure reduction. The patient was receiving vns therapy at the time of death. The neurologist does not believe the death to be related to vns therapy. The death was not witnessed and an autopsy was performed. An internal sudep evaluation was performed by the manufacturer which determined the death to be probable sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6403961
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dennis100
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« Reply #87 on: May 06, 2019, 03:00:23 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/25/2007
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6403893
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dennis100
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« Reply #88 on: May 06, 2019, 03:01:05 AM »

Lot Number 8861
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/15/2010
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
Product information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6402318
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dennis100
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« Reply #89 on: May 07, 2019, 06:49:37 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/29/2014
Event Type  Death   
Event Description
The patient had passed away in 2014. No cause of death was provided. An internal database review of settings revealed that the patient's generator was programmed on at therapeutic settings as of 12/03/2013. Diagnostics indicate that the device was functioning at this time. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. No additional relevant information has been received regarding the patient's passing.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6387859
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