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dennis100
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« on: February 24, 2019, 03:09:07 AM »

Model Number 102
Event Date 07/15/2005
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient passed away on (b)(6) 2005. The patient¿s last known neurologist has no record of the patient in their system; therefore, no further information can be received from the physician. Per the department of vital records in the state the patient passed away in, the manufacturer is not eligible to obtain a copy of the patient¿s death certificate. A sudep evaluation was performed by the manufacturer which determined the patient¿s death to be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4398028
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dennis100
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« Reply #1 on: February 24, 2019, 03:09:53 AM »

Model Number 102
Event Type  Death   
Event Description
This death event has been reviewed and with the available information has been determined to be possible sudep by manufacturer nurse. The only known factors are that the patient had epilepsy and died. As such, sudep cannot be ruled out as a possible cause of death. Attempts for further information have been unsuccessful to date and the physician has no further information on the event.
 
Manufacturer Narrative

Event Description
It was reported that the patient had passed away. No other information is known at this time. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2378305
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dennis100
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« Reply #2 on: February 24, 2019, 03:10:25 AM »

Model Number 102
Event Date 06/09/2005
Event Type  Death   
Event Description
It was reported that the pt was deceased. No cause of death or other info was given. Attempts for further info have been unsuccessful to date.
 
Event Description
This death event has been reviewed by a manufacturer nurse and with the available information has been determined to be possible sudep. The patient had epilepsy and died, but no other information is known. As such, sudep cannot be ruled out as a possible cause of death. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2405539
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dennis100
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« Reply #3 on: February 24, 2019, 03:11:05 AM »

Model Number 101
Event Date 06/10/2010
Event Type  Death   
Event Description
It was reported via a call from the coroner's office that they were attempting to confirm the identity of a patient who was implanted with a vns device. The patient's name and device information was confirmed. The coroner stated that the preliminary autopsy notes that the patient "was found in his unlocked one room apartment in rooming house. He is in a decomposed state. A subcutaneous pacer observed and seizure medications found in room. " the preliminary autopsy notes that the cause of death is pending further study. The autopsy is not completed at this time, however, the manufacturer is to be notified of the results when completed. The explanted lead and generator have been returned to manufacturer where analysis is underway. Further follow-up with the patient's treating neurologist revealed that the physician does not manage the vns device and only manages the patient's seizure medications. The nurse was not aware of the name of the physician who does manage the patient's device, and attempts to obtain this information from the neurologist have been unsuccessful to date. There is no programming or diagnostic history available to the manufacturer. The nurse stated that the patient was seen last on (b)(6) 2010, where the physician noted that the patient was "fine" at that time. A sudep evaluation performed by the manufacturer has preliminarily determined the death to be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__id=1754808
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dennis100
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« Reply #4 on: February 24, 2019, 03:11:51 AM »

Model Number 103
Event Date 11/16/2011
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient passed away. No other details given. Attempts for further information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician indicating that the death was not witnessed and no details are available regarding the exact cause of death, but the physician does not feel the death is related to vns. The patient had a reduction in seizures with vns and was receiving therapy at the time of death. Then patient was compliant with aeds, but was "poorly compliant with required follow-up and maintenance visits", per physician. This death event has been reviewed by manufacturer nurse and with the available information has been determined to be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2378374
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dennis100
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« Reply #5 on: February 24, 2019, 03:12:24 AM »

Model Number 101
Event Date 12/29/2008
Event Type  Death   
Event Description
It was reported that the patient was deceased. No cause of death or other information was given. Attempts for further information have been unsuccessful to date.
 
Event Description
This death event has been reviewed by a manufacturer nurse and with the available information has been determined to be possible sudep. The patient had epilepsy and died, but no other information is known. As such, sudep cannot be ruled out as a possible cause of death. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2403060
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dennis100
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« Reply #6 on: February 24, 2019, 03:13:33 AM »

Model Number 102R
Event Date 01/20/2015
Event Type  Death   
Manufacturer Narrative

Manufacturer Narrative
Review of the available programming and diagnostic history.
 
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. The patient¿s device was explanted and was returned to the manufacturer for analysis. Monitoring of the device output signal 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. The device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. There is no evidence to suggest an anomaly with the returned portions of the device. Note that since the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead. 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
Death certificate was received on (b)(6) 2015 and indicated the following additional information. The patient¿s place of death was in the hospital. Disposition of the deceased was burial. Manner of death was not indicated. Cause of death was respiratory failure (minutes) / status epilepticus (days)/ sepsis (days)/ urinary tract infection (days). Other significant conditions contributing to death were indicated as profound mental retardation, history of stroke, seizures. Autopsy was not performed. Programming history was reviewed for the patient¿s device. The last known settings system diagnostics were from (b)(6) 2010 and were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4699334
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dennis100
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« Reply #7 on: February 24, 2019, 03:14:11 AM »

Model Number 103
Event Date 10/22/2013
Event Type  Death   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2014, this patient death was reported. The death was attributed to sudep. Follow-up showed that the patient was seizure free was vns therapy. Settings were provided up to (b)(6) 2013, but no other information regarding the patient¿s death was known. Review of programming history showed that the last diagnostics are from (b)(6) 2012 and were within normal limits. An in-house sudep evaluation showed possible sudep. Review of online obituaries showed the date of death to be (b)(6) 2013. Follow-up with the funeral home showed that the patient was buried with the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3667938
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dennis100
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« Reply #8 on: February 24, 2019, 03:14:48 AM »

Model Number 102R
Event Date 04/27/2009
Event Type  Death   
Event Description
Reporter indicated a vns pt died and the death was not related to the vns. The pt was at home in his room at the time of the death and was found by his mother. The pt was receiving vns therapy at the time of death. An autopsy was not performed and the vns device was not explanted. With the available information, the manufacturer has determined that the death was probable sudep. Attempts for the death certificate are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__id=1412361
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dennis100
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« Reply #9 on: February 24, 2019, 03:15:50 AM »

Model Number 102
Event Date 03/12/2016
Event Type  Death   
Event Description
Additional information was received that the patient had passed away on (b)(6) 2016. The patient's devices were explanted on (b)(6) 2016 by the medical examiner's office but have not been received to date. Patient was re-admitted in to (b)(6) hospital around (b)(6) 2016 due to experiencing seizures. After seizures, patient clutches the generator site and complained of pain. According to the treating physician, this has occurred several times. The hospital requested the device be checked and a field representative performed interrogation and diagnostics. The physician was informed about using the magnet to disable the patient's device and was asked to contact the patient's neurologist for further instruction. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. The autopsy results were requested from the medical examiner's office but were not received to date as the autopsy is not yet completed.
 
Event Description
Death certificate and the autopsy results were received indicating that the patient's immediate cause of death was hypertensive cardiovascular disease. The manner of death is natural. The patient died while in hospice care. Patient's medical history is significant for congestive heart failure, liver and kidney failure, (b)(6), mental retardation and dementia. Patient also has a clinical history of seizure disorder. Per the autopsy results, the heart is markedly enlarged and globular with four-chamber dilatation and diffuse endocardial fibrosis of the left ventricle. The lungs are edematous, and the right lower lung lobe is collapsed, the liver is mottled. The right kidney has marked cortical pitted scars consistent with remote infarction or possible chronic pyelonephritis. A vagus nerve stimulator is in place. As such, the cause of death is hypertensive cardiovascular disease. Hepatitis c is a contributory cause.
 
Manufacturer Narrative

Event Description
The explanted devices were received for analysis on 05/02/2016. 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 typical wear and explant related observations, no anomalies were identified in the returned lead portion. Analysis of the generator is underway and has not been completed to date.
 
Manufacturer Narrative
Additional manufacturer narrative and/or corrected data: supplemental report #1 inadvertently omitted the identifiers of the corrected data fields, which were (describe event or problem) and (relevant tests/laboratory data, including dates) regarding details of the patient¿s hospital admission and device diagnostics respectively.
 
Event Description
It was reported that the patient was admitted to the icu due to seizures. The nurse at the icu reported that the patient grabs at the area of vns but is unable to communicate the issue due to pre-existing conditions. Due to this, a device issue is suspected and the nurse was informed about the use of magnet in disabling the stimulation and referred to patient's neurologist who can disable the device. Additional information was received from the nurse at the icu about patient's admission on (b)(6) 2016 due to nausea and vomiting. On (b)(6) 2016, patient experienced seizures. At night around 1 pm on (b)(6) 2016, patient grabbed the left chest at the generator site and reported pain. Patient was given pain medication and the magnet was not used to disable the device. On (b)(6) 2016, patient reported pain again around 4 pm. Patient was reported to have been discharged after (b)(6).
 
Event Description
In the (b)(4) 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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 in the (b)(4) lab concluded proper functionality of the pulse 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=5549413
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dennis100
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« Reply #10 on: February 24, 2019, 03:16:43 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/10/2015
Event Type  Death   
Manufacturer Narrative

Event Description
The patient's generator and lead were returned to the manufacturer, and product analysis was completed for the generator. Monitoring of the device output signal 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. Other than findings attributed to the device explant procedure, no visual anomalies were found on the generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The internal device data revealed that 59. 735% of the battery had been consumed and no anomalies were contained. Analysis of the returned lead is currently underway. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient passed away. An online obituary search determined the date of death was (b)(6) 2015. Information from the funeral home indicates the cause of death was respiratory failure, but no information was provided on what led to the respiratory failure or the circumstances of death. The relationship of the patient's death to vns therapy is unknown. Review of programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Based on the limited available information about the patient's death, an internal classification has determined that the death may be possible sudep. The device was explanted, but has not been returned to date. No additional pertinent information has been received to date.
 
Event Description
Product analysis of the patient's returned lead portion was completed. No electrical discontinuities were identified within the returned lead portion. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. No adverse effect was identified on the device performance. Note that since a 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. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5358583
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dennis100
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« Reply #11 on: February 24, 2019, 03:18:24 AM »

Model Number 102
Event Date 08/16/2013
Event Type  Death   
Event Description
It was reported by the physician that the patient had died. Follow up found that the date of death was (b)(6) 2013. It was reported that the aptient was found in the bathroom after an apparent seizure. The patient had incontinence. The family was insistent that the patient had not missed any medication and there was no known cause for a seizure. They do not plan for an autopsy. Good faith attempts have been made; however, they have been unsuccessful. No additional information has been provided.
 
Manufacturer Narrative
Date received by manufacturer; corrected date: previously submitted mdr inadvertently provided a wrong date for this field (08/25/2014). The correct date for this field is 09/02/2014. This report is being submitted to correct this date.
 
Event Description
Additional information was received indicating that the vns patient had passed away from "natural causes¿. The coroner noted bruising on the left eyelid and bruising and swelling of the tongue, which indicates that the patient possibly had a seizure and bit his tongue prior to death. An autopsy was not performed and a blood sample was not ordered. The cause of death was listed as ¿seizure¿. The coroner¿s report noted that the patient had a history of seizures and was implanted with a vns device. It is believed that the patient¿s device was not explanted prior to burial; therefore, no analysis can be performed. With the available information, 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=3350634
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dennis100
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« Reply #12 on: February 24, 2019, 03:18:57 AM »

Model Number 101
Event Date 04/09/2009
Event Type  Death   
Event Description
It was reported to manufacturer that the vns pt passed away. Further follow up with the pts treating vns neurologist, revealed that the "pt was taking a nap. Mom went in to check on him, and he was not breathing. Mom called ems". The physician noted that the device was not explanted, not available from the physician's office. The pt was on the following aed's at the time of death: phenytoin, clonazepam, trileptal, zonegran, and lyrica. The pt was receiving vns therapy at the time of death. The physician does not believe that the death is related to vns therapy. Attempts to obtain the death certificate from the vital records department have been made, but no information has been received to date. The manufacturer has determined the death to be probable sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1392583
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dennis100
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« Reply #13 on: February 24, 2019, 03:20:17 AM »

Model Number 102R
Event Date 05/02/2013
Event Type  Death   
Event Description
It was reported that the patient passed away approximately 3-4 months ago. The cause of death is not know at this time. It was reported that the patient had a pacemaker and known cardiac issues which was previously reported in mfr. Report # 1644487-2013-00834. Attempts to obtain additional information will be made, but no information has been obtained to date.
 
Event Description
Analysis of the returned generator and lead was completed. There were no performance or any other type of adverse conditions found with the pulse generator. The device was confirmed to be at end of service as result of normal battery depletion. The depletion was an expected event as determined by the blc and battery voltage measurement. The module performed according to functional specifications. There is no evidence to suggest an anomaly with the returned portions of the lead. During the visual analysis, the (+) white and (-) green electrodes appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the ribbons from coming in contact with the vagus nerve. With the exception of the tissue-covered (+) white and (-) green electrodes, the condition of the returned lead portions is 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, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Note that since a large portion of the lead assembly (body) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
Additional information was received stating that the vns patient¿s device was at end of service on (b)(4) 2010.
 
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient passed away on (b)(6) 2013. The patient was found dead on his bed in a supine position. The patient device¿s was disabled at the time of death and was not explanted. It was reported that the patient¿s death was not related to vns. An internal review of the available information determined that the patient¿s death was possible sudep.
 
Manufacturer Narrative
Additional information indicates that the patient¿s dob was (b)(6) 1946.
 
Event Description
Additional information was received stating that the vns patient was born on (b)(6) 1946, not (b)(6) 1949 as initially reported. The patient¿s death certificate was obtained. The death certificate listed the immediate cause of death as cardiopulmonary arrest with probable acute coronary syndrome and probable coronary artery disease as sequential conditions that contributed to the death. The patient had other significant health conditions may have contributed to the patient¿s condition. Nurse¿s notes regarding the patient¿s death were received. The notes indicate that the patient was being closely monitored due to treatment with continuous positive airway pressure (cpap). It was noted that the patient¿s cpap mask had be adjusted frequently. No issues were noted with the patient when he was evaluated at 11:00 pm on (b)(6) 2013. At 11:45 pm, the notes indicate that nurse required assistance adjusting the patient¿s cpap mask because the patient kept removing it. At midnight, nurse reported that the patient was pale, warm to touch, breathless, non-responsive, and pulseless. Cpr was immediately initiated and the paramedics that arrived approximately ten minutes later continued cpr until the patient was pronounced dead at 12:33 am on (b)(6) 2013. Follow-up with the nurse revealed that the patient was not having a seizure at the time of death the patient¿s seizure record indicated that the patient experienced several seizures from (b)(6) 2013 which consisted of stiffening, jerking, some forward head drops, flinging of the arms. The patient¿s postictal periods were uneventful with good recovery. With the available information, an internal classification determined that the death was unlikely sudep. The patient¿s body was donated to science and the patient¿s devices were explanted. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3506710
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dennis100
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« Reply #14 on: February 24, 2019, 03:21:12 AM »

Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the vns patient passed away. It was reported that the patient had been implanted with vns for many years and she died suddenly. It was reported that the emergency services were called by the patient¿s family and they were advised to initiate resuscitation maneuvers on the patient. It was reported that the paramedics used an automatic external defibrillator when they arrived. The automated external defibrillator did not advice to deliver any shocks. Further information was received stating that, on the date of death, the patient had indicated to her spouse that she felt unwell. Around 11:30 pm the patient suffered a severe seizure while in bed. Approximately one hour later, including the post-ictal period, the patient and the spouse fell asleep. Around 3:00 am the patient¿s spouse woke up and attempted to wake up the patient, but she did not react. The spouse requested medical aid and resuscitation maneuvers were started by family members. Upon arrival of the paramedics, an automated external defibrillator was used. The automated external defibrillator advised to continue with resuscitation and it did not advise to deliver shocks. It was reported that asystole was suspected. The resuscitation attempts were unsuccessful and the patient passed away. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be probable sudep. Attempts to obtain further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4952029
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dennis100
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« Reply #15 on: February 24, 2019, 03:21:47 AM »

Model Number 101
Event Date 10/09/2009
Event Type  Death   
Event Description
It was reported that the pt died in 2009 at his group home. Per reporter, the pt was found by his attendant, nude in a dry bathtub, and was dry to the touch. Pt was transported to the hospital, but was pronounced dead. The death was not witnessed. Per the reporter, the pt's vns was turned off at the time of death. Follow-up with the medical examiner reveals that the cause of death is undetermined at this time. Based on the info received to date, the event has been determined to be a possible sudep by a manufacturer medical professional. The product was explanted from the pt and returned to manufacturer, but analysis is pending. A voluntary medwatch was submitted to fda regarding this event. Attempts to contact treating physician for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__id=1581925
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dennis100
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« Reply #16 on: February 24, 2019, 03:22:36 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/18/2016
Event Type  Death   
Event Description
It was reported that the patient had passed away, as confirmed through an online obituary. She was found unresponsive by the nursing staff at her care facility after a possible seizure. Cpr was attempted, but the patient had expired. The patient was previously in the hospital the week before her passing for blood clots, and was transferred to a skilled nursing facility after being in the hospital for a few days. The device history records of the lead and generator were reviewed and found that all specifications were met prior to distribution. 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.
 
Manufacturer Narrative

Event Description
The county coroner showed that the patient¿s death was reported to them, but they did not handle the patient¿s case and had no autopsy report on it. Communications with the office of the treating physician showed that the patient¿s family was requesting an autopsy. The office confirmed that no warnings for abnormal impedance were seen in the last office visit. The patient¿s treating rehabilitation center reported that in the days preceding her death, the patient was diagnosed with dilantin toxicity. The patient then had a seizure and was also found to be very hypoxic. Computed tomography angiography (cta) showed many pulmonary embolisms. The patient was started on a lovenox/coumadin bridge, and her dilantin dose was decreased. Once patient was medically stable, she was transferred to the rehabilitation center. The next day, the patient had a witnessed seizure and appeared to be stable following the seizure. Approximately one hour later, the patient was found pulseless in her room. She was rushed to the hospital and had cpr performed without success. The patient was pronounced dead by the hospital emergency department. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6252764
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« Reply #17 on: February 24, 2019, 03:23:18 AM »

Model Number 102R
Event Date 02/11/2013
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the vns patient passed away on (b)(6) 2013. No autopsy was performed and the patient¿s device was not explanted. The believed cause of death was listed as pneumonia, sepsis question of lung cancer. It was noted that the patient achieved seizure reduction with vns; however, the relationship between the death and vns is unknown. Based on the 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=4278067
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dennis100
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« Reply #18 on: February 24, 2019, 03:24:02 AM »

Event Date 05/23/2011
Event Type  Death   
Event Description
It was reported that the pt had passed away. The physician has not seen this pt in a long time and the pt was being followed by an unk physician, so the details surrounding death are unk at this time.
 
Event Description
Evaluation by a manufacturer nurse reveals that the patient's death is a possible sudep. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2180777
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dennis100
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« Reply #19 on: February 24, 2019, 03:25:22 AM »

Model Number 102
Device Problem Insufficient Information
Event Date 06/11/2012
Event Type  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 underlying cause of death was potential sudep. The cause of death per the ndi was infantile cerebral palsy, sleep apnea, encephalopathy, and other unspecified convulsions. 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.
 
Event Description
On (b)(6) 2012, the vns patient's mother reported that the patient passed away last night. The mother mentioned that the patient was having seizures, but no indication of an increase. Good faith attempts to the physician for further information were made but no additional information was received. The department of state health in the state the patient passed away in reported that they will not provide death certificates to the manufacturer. A review of the patient's programming history revealed that the patient was last programmed to output=2. 75ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=0. 8min/magnet output=3ma/magnet pulse width=250usec/magnet on time=60sec on (b)(6) 2011. A battery life calculation was performed which showed 0. 34 years remaining until the elective replacement indicator flagged as "yes. " with the available information provided to the manufacturer thus far, the patient's death has been determined to be possible sudep.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2639930
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« Reply #20 on: February 24, 2019, 03:26:24 AM »

Event Date 12/01/2011
Event Type  Death   
Event Description
Further information was received from the treating nurse indicating that no additional information was available regarding the reported events. This death event has been reviewed by the manufacturer and with the available information has been determined to be possible sudep. The only known factors are that the patient had epilepsy and died. As such, sudep cannot be ruled out as a cause of death.
 
Manufacturer Narrative

Event Description
It was reported by a company representative that a vns patient had passed away on (b)(6) 2011. The patient had not been seen for follow up visits since 2005, and was reported to be experiencing an increase in tonic clonic seizures. The patient was seen by a new physician in (b)(6) 2011 and a new aed was introduced. At the moment, the cause of death is unknown as the coroner has very few details and an autopsy is not available. Good faith attempts to obtain further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2389547
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« Reply #21 on: February 24, 2019, 03:27:07 AM »

Event Date 05/18/2015
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the vns patient passed away on (b)(6) 2015 from natural causes. The cause of death and its relationship to vns are unknown. No autopsy was performed and the patient¿s device was not explanted prior to burial. 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=4859679
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« Reply #22 on: February 24, 2019, 03:27:48 AM »

Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the vns caregiver was told by an unknown physician that there were three cases where pediatric patients had passed away due to cardiac arrest from vns. Attempts for additional relevant information have been unsuccessful to date. Based on the limited available information about the patients¿ deaths, an internal classification has determined that the deaths may be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4838774
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« Reply #23 on: February 24, 2019, 03:28:24 AM »

Model Number 103
Event Date 04/01/2015
Event Type  Death   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
It was reported that the vns patient passed away in (b)(6) 2015. The cause of death and its relationship to vns are unknown. 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) 2013. A battery life calculation using the available programming history showed > 10 years remaining. 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=4824699
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« Reply #24 on: February 24, 2019, 03:29:05 AM »

Model Number 102
Event Date 05/20/2014
Event Type  Death   
Manufacturer Narrative

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. No further information relevant to the death has been received to date. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4775834
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« Reply #25 on: February 24, 2019, 03:29:36 AM »

Model Number 102R
Event Type  Death   
Event Description
It was reported that the patient had passed away about a year prior per the neurologist. Follow-up with the neurologist revealed that the patient had not been seen for approximately eight years, and the cause of death was unknown. No additional information was provided by the neurologist. Follow-up with the county of residence coroner¿s office was performed, but they were unable to locate information regarding the patient¿s death. (b)(6) attempts for additional relevant information have been unsuccessful. With the available information, the death was reviewed by the manufacturer and classified as possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4743812
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« Reply #26 on: February 24, 2019, 03:30:20 AM »

Model Number 102
Event Date 06/04/2012
Event Type  Death   
Manufacturer Narrative
Analysis of programming history performed.
 
Event Description
On (b)(6) 2013 a sudep evaluation was performed by the manufacturer with the information available and it was determined that the patient¿s death is considered to be possibly sudep related.
 
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: atherosclerotic heart disease; benign neoplasm of adrenal gland; myocardial degeneration; cardiomegaly; atherosclerosis of aorta. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
It was reported that the patient had not been seen in a long time, and the treating physician was unknown. The company case manager searched online and found an obituary for the patient who passed away on (b)(6) 2012. The reason is unknown. The patient¿s previously treating physician moved a few years prior and no longer practices vns. The patient passed away outside of his care. Review of the company programming history database revealed the patient¿s last programming physician was another physician (on (b)(6) 2010). Attempts for additional information from this physician have been unsuccessful to date.
 
Event Description
Follow-up with the funeral home was done and they did not have the generator or lead for return.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3205872
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« Reply #27 on: February 24, 2019, 03:31:00 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/09/2015
Event Type  Death   
Event Description
Follow-up to the physician at the patient's group home revealed the patient's cause of death was respiratory failure, restrictive lung disease due to scoliosis, and aspiration pneumonia due to dysphagia. The physician stated that vns did not contribute to the dysphagia or the cause of death.
 
Manufacturer Narrative
Suspect device udi: (b)(4).
 
Event Description
It was reported that the vns patient passed away on (b)(6) 2015. The cause of death and its relationship to vns are unknown. It was noted that the patient had been hospitalized the past month due to fever and aspiration unrelated to vns. No further information relevant to the event has been received to date. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4889279
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« Reply #28 on: February 24, 2019, 03:31:43 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/09/2015
Event Type  Death   
Event Description
Follow-up to the physician at the patient's group home revealed the patient's cause of death was respiratory failure, restrictive lung disease due to scoliosis, and aspiration pneumonia due to dysphagia. The physician stated that vns did not contribute to the dysphagia or the cause of death.
 
Manufacturer Narrative
Suspect device udi: (b)(4).
 
Event Description
It was reported that the vns patient passed away on (b)(6) 2015. The cause of death and its relationship to vns are unknown. It was noted that the patient had been hospitalized the past month due to fever and aspiration unrelated to vns. No further information relevant to the event has been received to date. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4889279
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« Reply #29 on: February 24, 2019, 03:32:25 AM »

Model Number 102
Event Date 08/04/2006
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient passed away on (b)(6) 2016. She was found deceased in her home. The physician reported that the patient had cps and gtc seizures along with morbid obesity and depression. The patient was presumably seizure free, according to the physician's report. An autopsy was not performed, but the generator and lead were explanted and discarded. The patient's last visit to her physician was on (b)(6) 2006, and the patient was receiving vns therapy at the time of death to the physician's knowledge. The patient was on topimate and lamotrigine at the time of death. The relationship of the death and vns was unknown since the cause of death was unknown, but the physician did not attribute the death to vns. Additional information was received from the national death index. The cause of death was: major cardiovascular disease, generalized and unspecified atherosclerosis, other obesity, unspecified depressive episode, unspecified epilepsy, unspecified asthma, and unspecified arthrosis. A sudep (sudden unexpected death in epilepsy patients) evaluation was performed based on information from the national death index, and the death was determined to be probable sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5983626
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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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« 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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« 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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« 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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« 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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« 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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« 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
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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
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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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« 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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« 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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« 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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« 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
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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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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« Reply #90 on: May 08, 2019, 10:02:05 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/09/2015
Event Type  Death   
Event Description
It was reported that the patient had passed away. Additional relevant information has not been received despite multiple attempts. 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=6378310
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« Reply #91 on: May 08, 2019, 10:02:36 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Death   
Event Description
The patient was reported to have passed away. An obituary could not be found. No additional relevant information has been received regarding patient's cause of death. 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=6526476
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« Reply #92 on: May 14, 2019, 12:19:32 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/04/2010
Event Type  Death   
Event Description
It was found that the patient passed away from an obituary. Additional relevant information 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=6465546
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« Reply #93 on: May 14, 2019, 12:20:08 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/24/2015
Event Type  Death   
Event Description
It was reported by a company representative that this patient passed away. The representative found this from the neurologist office and the neurologist did not have any information on patient's cause of 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6455278
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« Reply #94 on: May 18, 2019, 12:04:43 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/19/2013
Event Type  Death   
Event Description
It was found that the patient passed away per an online obituary. No additional relevant information was received to date. 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=6569730
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« Reply #95 on: May 30, 2019, 05:26:49 AM »

Model Number 102
Device Problem Low Battery
Event Date 04/19/2017
Event Type  Death   
Event Description
Patient was referred for prophylactic generator replacement based on estimated battery life calculation (0 years remaining). Low battery warning was also observed per the clinic notes. Prior to generator replacement, however, the patient passed away. The family informed the surgeon's office that the patient would not be able to attend the consult as the passed away. Information was received from the patient's neurologist that the patient's response to vns therapy was seizure reduction. However, no details regarding the death was known to the neurologist. Patient has a history of 2nd generalized and complex partial seizures. Patient was compliant with medications and was on primidone, carbamazepine, lamotrigine, and few other medications. Patient was undergoing evaluation for replacement of vns due to generator failure/battery depletion. 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=6607900
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dennis100
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« Reply #96 on: June 28, 2019, 10:00:05 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/19/2017
Event Type  Death   
Manufacturer Narrative
 
Event Description
It was reported that the patient passed away in his sleep. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7541963
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